Complicated Intra-abdominal Infection
Conditions
Keywords
Ceftazidime-avibactam,, Metronidazole,, complicated intra-abdominal infection
Brief summary
Study C3591036 is a Phase 3 study to assess the efficacy and safety of PF-06947386 in Japanese adult patients with complicated intra-abdominal infection requiring hospitalization. This is a multicenter, open-label, single-arm study. All eligible participants will receive intravenous infusion of PF-06947386 followed by intravenous infusion of metronidazole.
Interventions
DRUGPF-06947386
Ceftazidime-Avibactam powder for concentrate for solution for infusion 2.0 g/ 0.5 g. Dosage will be adjusted based on renal function after enrollment.
DRUGMetronidazole
Metronidazole 0.5 g solution for injection.
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant who is capable of giving signed, dated and timed informed consent (or by their legally acceptable representative) * Participant aged 20 years or older * Participant who is willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures * Confirmation of infection by surgical intervention within 24 hours of entry: evidence of systemic inflammatory response; physical findings consistent with intra-abdominal infection; supportive radiologic imaging findings of intra-abdominal infections * Intraoperative/postoperative enrollment with visual confirmation (presence of pus within the abdominal cavity) of an intra-abdominal infection associated with peritonitis
Exclusion criteria
* Participant will undergo surgery for traumatic bowel perforation within 12 hours or perforation of gastroduodenal ulcers within 24 hours. Other intra-abdominal processes that are not infectious. * Participant has abdominal wall abscess or bowel obstruction without perforation or ischemic bowel without perforation * Participant whose surgery will include staged abdominal repair, or open abdomen technique, or marsupialization. * Participant has evidence of sepsis with shock not responding to IV fluid challenge or anticipated to require the administration of vasopressors for \>24 hours * Participant has suspected intra-abdominal infections due to fungus, parasites (eg, amebic liver abscess), virus, or tuberculosis * Participant is considered unlikely to survive the 6- to 8-week study period or has a rapidly progressive or terminal illness * Participant is pregnant or breastfeeding. * Participant has received systemic antibacterial agents within the 72-hour period prior to study entry except for cases specified in the protocol such that participant is considered to have failed the previous treatment regimen, or participant has received systemic antibiotic agents no more than 24 hours (no more than one daily dose) within the 72-hour period prior to study entry, etc. * Estimated CrCL ≤50 mL/min calculated by Cockcroft-Gault method.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinical Response at Test of Cure (TOC) Visit: Clinically Evaluable (CE) Analysis Set | TOC: Any day from Day 28 to Day 35 | Clinical response: Clinical response of cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within the abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptoms of intra-abdominal infection; Indeterminate: Study data was not available for evaluation of efficacy for any reason. TOC was after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Microbiological Response EOT, TOC and LFU Visits: ME Analysis Set | EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49 | Microbiological response: Favorable microbiological response assessments include eradication, presumed eradication and colonization. Unfavorable microbiological response assessments include persistence, persistence with increasing MIC, and presumed persistence. Indeterminate: Study data was not available for evaluation of efficacy. Indeterminate were not included in the denominator. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion. |
| Percentage of Participants With Favorable Per-Pathogen Microbiological Response by Minimum Inhibitory Concentration (MIC) Categories at EOT, TOC and LFU Visits: mMITT Analysis Set | EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49 | Microbiological response: Favorable microbiological response assessments include eradication, presumed eradication and colonization. Unfavorable microbiological response assessments include persistence, persistence with increasing MIC, and presumed persistence. Indeterminate: Study data was not available for evaluation of efficacy. Indeterminate were not included in the denominator. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion. |
| Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: ME Analysis Set | EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49 | Microbiological response: Favorable microbiological response assessments include eradication, presumed eradication and colonization. Unfavorable microbiological response assessments include persistence, persistence with increasing MIC, and presumed persistence. Indeterminate: Study data was not available for evaluation of efficacy. Indeterminate were not included in the denominator. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion. |
| Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: eME Analysis Set | EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49 | Microbiological response: Favorable microbiological response assessments include eradication, presumed eradication and colonization. Unfavorable microbiological response assessments include persistence, persistence with increasing MIC, and presumed persistence. Indeterminate: Study data was not available for evaluation of efficacy. Indeterminate were not included in the denominator. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion. |
| Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs (SAEs) | Up to Day 49 | An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was defined as any untoward medical occurrence that, at any dose that resulted in death, was life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent disability/incapacity, a congenital anomaly/birth defect as per medical or scientific judgment. AEs included both SAEs and non-SAEs. TEAE was defined as an AE that emerges or worsened during the effective duration of treatment. All events that started on or after the first dosing day were flagged as TEAEs. |
| All-cause Mortality | Up to Day 49 | Number of participants with death is presented. |
| Number of Participants Who Discontinued Treatment and Study Due to Adverse Events | Up to Day 49 | Number of participants who discontinued treatment and study due to adverse events is presented. |
| Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline, Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, and EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49 | A semiautomated recording device was used to measure SBP and DBP with participant in a supine position after at least 5 minutes of rest. |
| Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Pulse Rate | Baseline, Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, and EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49 | Pulse rate was measured for in a supine position preceded by at least 5 minutes of rest for the participant. |
| Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Weight | Baseline, Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, and EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49 | Body weight was measured using a balance scale. |
| Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Temperature | Baseline, Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, and EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49 | Temperature was measured in a supine position, after the participant had rest for at least 5 minutes. |
| Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Respiratory Rate | Baseline, Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, and EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49 | Respiratory rate was measured in a supine position, after the participant had rest for at least 5 minutes. |
| Number of Participants With Laboratory Test Abnormalities | Up to Day 49 | Criteria for abnormal laboratory values for chemistry parameters: Bilirubin \>1.5\*upper limit of normal (ULN), direct Bilirubin \>1.5\*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase \>3.0\*ULN, total protein and albumin \<0.8\*lower limit of normal (LLN), urea nitrogen and creatinine \>1.3\*ULN, sodium \>0.95\*LLN, potassium \>0.9\*LLN and \>1.1\*ULN, calcium \>0.9\*LLN, glucose \> 1.5\*LLN; hematology parameters: Hemoglobin, hematocrit, erythrocytes \<0.8\*LLN, platelets \<0.5\*LLN and \> 1.75\*ULN, leukocytes \<0.6\*LLN and \<0.6\*LLN, lymphocytes \<0.8\* LLN, lymphocytes/leukocytes \<0.8\* LLN and \>1.2\*ULN, neutrophils \>1.2\*ULN, neutrophils/leukocytes \<0.8\*LLN and \>1.2\* ULN, basophils/leukocytes \>1.2\*ULN, eosinophils \>1.2\*ULN, eosinophils/leukocytes \>1.2\*ULN, monocytes and monocytes/leukocytes \>1.2\*ULN; Criteria for abnormal laboratory values for urinalysis parameters: urine glucose, \>=1, urine protein \>=1, urine Hemoglobin\>=1. |
| Plasma Concentration of Avibactam | Day 3, Day 4, and Combination of Day 3 and 4: 15 minutes before or after infusion, 30-90 minutes after infusion, 300-360 minutes after infusion | Plasma concentrations of avibactam was measured by nominal sampling window. |
| Plasma Concentration of Ceftazidime | Day 3, Day 4, and Combination of Day 3 and 4: 15 minutes before or after infusion, 30-90 minutes after infusion, 300-360 minutes after infusion | Plasma concentrations of ceftazidime was measured by nominal sampling window. |
| Percentage of Participants With Clinical Response at End of Treatment (EOT) and Late Follow-up (LFU) Visits: CE Analysis Set | EOT: 24 hours after last IV infusion; LFU: Any day from Day 42 to Day 49 | Clinical response: Clinical response of cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within the abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptoms of intra-abdominal infection; Indeterminate: Study data was not available for evaluation of efficacy for any reason. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. |
| Number of Participants With Clinical Response at EOT and LFU Visits: Modified Intent-to-Treat (MITT) Analysis Set | EOT: 24 hours after last IV infusion; LFU: Any day from Day 42 to Day 49 | Clinical response: Clinical response of cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within the abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptoms of intra-abdominal infection; Indeterminate: Study data was not available for evaluation of efficacy for any reason. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. |
| Number of Participants With Clinical Response at EOT and LFU Visits: Microbiological Modified Intent-to-Treat (mMITT) Analysis Set | EOT: 24 hours after last IV infusion; LFU: Any day from Day 42 to Day 49 | Clinical response: Clinical response of cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within the abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptoms of intra-abdominal infection; Indeterminate: Study data was not available for evaluation of efficacy for any reason. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. |
| Percentage of Participants With Clinical Response at EOT and LFU Visits: Microbiologically Evaluable (ME) Analysis Set | EOT: 24 hours after last IV infusion; LFU: Any day from Day 42 to Day 49 | Clinical response: Clinical response of cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within the abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptoms of intra-abdominal infection; Indeterminate: Study data was not available for evaluation of efficacy for any reason. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. |
| Percentage of Participants With Clinical Response EOT and LFU Visits: Extended Microbiologically Evaluable (eME) Analysis Set | EOT: 24 hours after last IV infusion; LFU: Any day from Day 42 to Day 49 | Clinical response: Clinical response of cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within the abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptoms of intra-abdominal infection; Indeterminate: Study data was not available for evaluation of efficacy for any reason. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. |
| Number of Participants With Microbiological Response EOT, TOC and LFU Visits: mMITT Analysis Set | EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49 | Microbiological response: Favorable microbiological response assessments include eradication, presumed eradication and colonization. Unfavorable microbiological response assessments include persistence, persistence with increasing MIC, and presumed persistence. Indeterminate: Study data are not available for evaluation of efficacy. Indeterminate were not included in the denominator. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion. |
| Percentage of Participants With Microbiological Response EOT, TOC and LFU Visits: eME Analysis Set | EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49 | Microbiological response: Favorable microbiological response assessments include eradication, presumed eradication and colonization. Unfavorable microbiological response assessments include persistence, persistence with increasing MIC, and presumed persistence. Indeterminate: Study data was not available for evaluation of efficacy. Indeterminate were not included in the denominator. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion. |
| Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: mMITT Analysis Set | EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49 | Microbiological response: Favorable microbiological response assessments include eradication, presumed eradication and colonization. Unfavorable microbiological response assessments include persistence, persistence with increasing MIC, and presumed persistence. Indeterminate: Study data was not available for evaluation of efficacy. Indeterminate were not included in the denominator. EOT: within 24 hours after completion of last IV infusion. Response of baseline pathogens cultured from intra-abdominal site or blood. A participant can have more than 1 pathogen. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion. |
| Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: ME Analysis Set | EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49 | Microbiological response: Favorable microbiological response assessments include eradication, presumed eradication and colonization. Unfavorable microbiological response assessments include persistence, persistence with increasing MIC, and presumed persistence. Indeterminate: Study data are not available for evaluation of efficacy. Indeterminate were not included in the denominator. EOT: within 24 hours after completion of last IV infusion. Response of baseline pathogens cultured from intra-abdominal site or blood. A participant can have more than 1 pathogen. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion. |
| Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: eME Analysis Set | EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49 | Microbiological response: Favorable microbiological response assessments include eradication, presumed eradication and colonization. Unfavorable microbiological response assessments include persistence, persistence with increasing MIC, and presumed persistence. Indeterminate: Study data was not available for evaluation of efficacy. Indeterminate were not included in the denominator. EOT: within 24 hours after completion of last IV infusion. Response of baseline pathogens cultured from intra-abdominal site or blood. A participant can have more than 1 pathogen. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinical Response at TOC: ME Analysis Set | TOC: Any day from Day 28 to Day 35 | Clinical response: Clinical response of cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within the abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptoms of intra-abdominal infection; Indeterminate: Study data was not available for evaluation of efficacy for any reason. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion. |
| Number of Participants With Clinical Response at TOC: eME Analysis Set | TOC: Any day from Day 28 to Day 35 | Clinical response: Clinical response of cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within the abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptoms of intra-abdominal infection; Indeterminate: Study data was not available for evaluation of efficacy for any reason. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion. |
| Number of Participants With Clinical Response at EOT, TOC and LFU Visits: Sepsis Participants Subset | EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49 | Clinical response of cure was defined as complete resolution or significant improvement of signs & symptoms of index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from day of 1st IV infusion, allowed visit window was 28¬-35 calendar days after day of 1st IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptom of intra-abdominal infection; Indeterminate:Study data was not available for evaluation of efficacy for any reason. EOT: within 24 hours after completion of last IV infusion. LFU:after 42 calendar days from day of 1st IV infusion, allowed visit window was 42-49 calendar days from 1st IV infusion. TOC:after 28 calendar days from 1st IV infusion, allowed visit window was 28-35 calendar days after 1st IV infusion. |
| Number of Participants With Clinical Response at EOT, TOC and LFU Visits: Sepsis Evaluable Participants Subset | EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49 | Clinical response of cure was defined as complete resolution or significant improvement of signs & symptoms of index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from day of 1st IV infusion, allowed visit window was 28¬-35 calendar days after day of 1st IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptom of intra-abdominal infection; Indeterminate:Study data was not available for evaluation of efficacy for any reason. EOT: within 24 hours after completion of last IV infusion. LFU:after 42 calendar days from day of 1st IV infusion, allowed visit window was 42-49 calendar days from 1st IV infusion. TOC:after 28 calendar days from 1st IV infusion, allowed visit window was 28-35 calendar days after 1st IV infusion. |
| Number of Participants With Microbiological Response EOT, TOC and LFU Visits: Sepsis Participants Subset | EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49 | Microbiological response: Favorable microbiological response assessments include eradication, presumed eradication and colonization. Unfavorable microbiological response assessments include persistence, persistence with increasing MIC, and presumed persistence. Indeterminate: Study data are not available for evaluation of efficacy. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion. |
| Number of Participants With Microbiological Response EOT, TOC and LFU Visits: Sepsis Evaluable Participants Subset | EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49 | Microbiological response: Favorable microbiological response assessments include eradication, presumed eradication and colonization. Unfavorable microbiological response assessments include persistence, persistence with increasing MIC, and presumed persistence. Indeterminate: Study data are not available for evaluation of efficacy. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion. |
| Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: Sepsis Participants Subset | EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49 | Microbiological response: Favorable microbiological response assessments include eradication, presumed eradication and colonization. Unfavorable microbiological response assessments include persistence, persistence with increasing MIC, and presumed persistence. Indeterminate: Study data was not available for evaluation of efficacy. EOT: within 24 hours after completion of last IV infusion. Response of baseline pathogens cultured from intra-abdominal site or blood. A participant can have more than 1 pathogen. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion. |
| Number of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: Sepsis Evaluation Participants Subset | EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49 | Microbiological response: Favorable microbiological response assessments include eradication, presumed eradication and colonization. Unfavorable microbiological response assessments include persistence, persistence with increasing MIC, and presumed persistence. Indeterminate: Study data was not available for evaluation of efficacy. EOT: within 24 hours after completion of last IV infusion. Response of baseline pathogens cultured from intra-abdominal site or blood. A participant can have more than 1 pathogen. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion. |
| Number of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: Sepsis Participants Subset | EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49 | Microbiological response: Favorable microbiological response assessments include eradication, presumed eradication and colonization. Unfavorable microbiological response assessments include persistence, persistence with increasing MIC, and presumed persistence. Indeterminate: Study data was not available for evaluation of efficacy. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion. |
| Number of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: Sepsis Evaluation Participants Subset | EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49 | Microbiological response: Favorable microbiological response assessments include eradication, presumed eradication and colonization. Unfavorable microbiological response assessments include persistence, persistence with increasing MIC, and presumed persistence. Indeterminate: Study data was not available for evaluation of efficacy. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion. |
| Number of Participants With Treatment Emergent AEs and SAEs: Sepsis Participants Subset | Up to Day 49 | An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was defined as any untoward medical occurrence that, at any dose that resulted in death, was life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent disability/incapacity, a congenital anomaly/birth defect as per medical or scientific judgment. AEs included both SAEs and non-SAEs. TEAE was defined as an AE that emerges or worsened during the effective duration of treatment. All events that started on or after the first dosing day were flagged as TEAEs. |
| Number of Participants With Treatment Emergent AEs and SAEs: Sepsis Evaluable Participants Subset | Up to Day 49 | An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was defined as any untoward medical occurrence that, at any dose that resulted in death, was life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent disability/incapacity, a congenital anomaly/birth defect as per medical or scientific judgment. AEs included both SAEs and non-SAEs. TEAE was defined as an AE that emerges or worsened during the effective duration of treatment. All events that started on or after the first dosing day were flagged as TEAEs. |
| Number of Participants With Clinical Response at TOC Visit: MITT Analysis Set | TOC: Any day from Day 28 to Day 35 | Clinical response: Clinical response of cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within the abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptoms of intra-abdominal infection; Indeterminate: Study data was not available for evaluation of efficacy for any reason. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion. |
| Number of Participants With Clinical Response at TOC Visit: mMITT Analysis Set | TOC: Any day from Day 28 to Day 35 | Clinical response: Clinical response of cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within the abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptoms of intra-abdominal infection; Indeterminate: Study data was not available for evaluation of efficacy for any reason. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion. |
Countries
Japan
Participant flow
Recruitment details
A total of 60 Japanese hospitalized participants with complicated intra-abdominal infection (cIAI) were enrolled in this study.
Participants by arm
| Arm | Count |
|---|---|
| PF-06947386 + Metronidazole Participants received intravenous (IV) infusion of PF-06947386 (2.0 gram (g) of ceftazidime and 0.5 g of avibactam) every 8 hours, immediately followed by an IV administration of metronidazole (0.5 g) for 60 minutes. Participants received a minimum of 5 full days (15 doses) of IV study intervention up to a maximum of 14 full days (42 doses) of study intervention. | 60 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Death | 1 |
| Overall Study | Other | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | PF-06947386 + Metronidazole |
|---|---|
| Age, Continuous | 56.5 Years STANDARD_DEVIATION 17.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 60 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 60 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 60 |
| other Total, other adverse events | 34 / 60 |
| serious Total, serious adverse events | 3 / 60 |
Outcome results
Primary
Number of Participants With Clinical Response at Test of Cure (TOC) Visit: Clinically Evaluable (CE) Analysis Set
Clinical response: Clinical response of cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within the abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptoms of intra-abdominal infection; Indeterminate: Study data was not available for evaluation of efficacy for any reason. TOC was after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.
Time frame: TOC: Any day from Day 28 to Day 35
Population: CE analysis set included participants who had an appropriate diagnosis of cIAI; either received therapy for greater than or equal to (\>=) 48 hours, with \>=80 percent (%) of the scheduled drug administered over number of days administered or received therapy less than (\<) 48 hours before discontinuing treatment due to an adverse event (AE).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06947386 + Metronidazole | Number of Participants With Clinical Response at Test of Cure (TOC) Visit: Clinically Evaluable (CE) Analysis Set | Clinical Cure | 36 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Clinical Response at Test of Cure (TOC) Visit: Clinically Evaluable (CE) Analysis Set | Clinical Failure | 4 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Clinical Response at Test of Cure (TOC) Visit: Clinically Evaluable (CE) Analysis Set | Indeterminate | 0 Participants |
Secondary
All-cause Mortality
Number of participants with death is presented.
Time frame: Up to Day 49
Population: Safety analysis set included all participants who received any amount of IV study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PF-06947386 + Metronidazole | All-cause Mortality | 1 Participants |
Secondary
Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Pulse Rate
Pulse rate was measured for in a supine position preceded by at least 5 minutes of rest for the participant.
Time frame: Baseline, Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, and EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49
Population: Safety analysis set included all participants who received any amount of IV study intervention. Here, Number Analyzed signifies participants included in safety analysis set at EOT, TOC and LFU respectively. Here, Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Pulse Rate | Day 8 | -9.1 Beats per minute | Standard Deviation 14.69 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Pulse Rate | Baseline | 82.6 Beats per minute | Standard Deviation 13.5 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Pulse Rate | Day 2 | -4.8 Beats per minute | Standard Deviation 11.54 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Pulse Rate | Day 3 | -7.1 Beats per minute | Standard Deviation 13.04 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Pulse Rate | Day 4 | -8.9 Beats per minute | Standard Deviation 14.92 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Pulse Rate | Day 5 | -11.3 Beats per minute | Standard Deviation 15.46 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Pulse Rate | Day 6 | -12.4 Beats per minute | Standard Deviation 15.61 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Pulse Rate | Day 7 | -11.0 Beats per minute | Standard Deviation 18.09 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Pulse Rate | Day 9 | -12.0 Beats per minute | Standard Deviation 20.25 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Pulse Rate | Day 10 | -8.0 Beats per minute | Standard Deviation 29.5 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Pulse Rate | Day 11 | -12.3 Beats per minute | Standard Deviation 24.57 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Pulse Rate | Day 12 | -18.7 Beats per minute | Standard Deviation 35.36 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Pulse Rate | Day 13 | -18.0 Beats per minute | Standard Deviation 37.51 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Pulse Rate | Day 14 | -24.5 Beats per minute | Standard Deviation 53.03 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Pulse Rate | EOT | -8.7 Beats per minute | Standard Deviation 16.56 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Pulse Rate | TOC | -8.8 Beats per minute | Standard Deviation 16.43 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Pulse Rate | LFU | -9.4 Beats per minute | Standard Deviation 16.07 |
Secondary
Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Respiratory Rate
Respiratory rate was measured in a supine position, after the participant had rest for at least 5 minutes.
Time frame: Baseline, Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, and EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49
Population: Safety analysis set included all participants who received any amount of IV study intervention. Here, Number Analyzed signifies participants included in safety analysis set at EOT, TOC and LFU respectively. Here, Number Analyzed signifies participants evaluable for specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Respiratory Rate | Baseline | 17.8 Breaths per minute | Standard Deviation 3.39 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Respiratory Rate | Day 2 | 0.4 Breaths per minute | Standard Deviation 5.91 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Respiratory Rate | Day 3 | -0.4 Breaths per minute | Standard Deviation 4.41 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Respiratory Rate | Day 4 | -1.1 Breaths per minute | Standard Deviation 3.97 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Respiratory Rate | Day 5 | -0.5 Breaths per minute | Standard Deviation 4.79 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Respiratory Rate | Day 6 | -1.3 Breaths per minute | Standard Deviation 3.9 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Respiratory Rate | Day 7 | -1.6 Breaths per minute | Standard Deviation 3.63 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Respiratory Rate | Day 8 | -1.1 Breaths per minute | Standard Deviation 2.66 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Respiratory Rate | Day 9 | -2.8 Breaths per minute | Standard Deviation 3.27 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Respiratory Rate | Day 10 | 0.2 Breaths per minute | Standard Deviation 3.19 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Respiratory Rate | Day 11 | -1.8 Breaths per minute | Standard Deviation 4.19 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Respiratory Rate | Day 12 | -3.3 Breaths per minute | Standard Deviation 4.16 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Respiratory Rate | Day 13 | -0.3 Breaths per minute | Standard Deviation 4.93 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Respiratory Rate | Day 14 | 0.5 Breaths per minute | Standard Deviation 9.19 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Respiratory Rate | EOT | -0.6 Breaths per minute | Standard Deviation 4.3 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Respiratory Rate | TOC | -1.2 Breaths per minute | Standard Deviation 4.15 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Respiratory Rate | LFU | -1.6 Breaths per minute | Standard Deviation 3.88 |
Secondary
Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
A semiautomated recording device was used to measure SBP and DBP with participant in a supine position after at least 5 minutes of rest.
Time frame: Baseline, Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, and EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49
Population: Safety analysis set included all participants who received any amount of IV study intervention. Here, Number Analyzed signifies participants included in safety analysis set at EOT, TOC and LFU respectively. Here, Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline, SBP | 119.0 Millimeters of Mercury | Standard Deviation 17.73 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 2, SBP | 3.8 Millimeters of Mercury | Standard Deviation 16.05 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 3, SBP | 6.1 Millimeters of Mercury | Standard Deviation 20.44 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 4, SBP | 8.0 Millimeters of Mercury | Standard Deviation 18.27 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 5, SBP | 8.2 Millimeters of Mercury | Standard Deviation 18.26 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 6, SBP | 2.2 Millimeters of Mercury | Standard Deviation 22.92 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 7, SBP | 2.8 Millimeters of Mercury | Standard Deviation 21.61 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 8, SBP | 4.9 Millimeters of Mercury | Standard Deviation 21.14 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 9, SBP | -9.6 Millimeters of Mercury | Standard Deviation 20.61 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 10, SBP | -8.6 Millimeters of Mercury | Standard Deviation 23.86 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 11, SBP | -11.8 Millimeters of Mercury | Standard Deviation 16.5 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 12, SBP | -16.3 Millimeters of Mercury | Standard Deviation 27.57 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 13, SBP | -10.7 Millimeters of Mercury | Standard Deviation 35.5 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 14, SBP | -20.0 Millimeters of Mercury | Standard Deviation 33.94 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | EOT, SBP | 2.1 Millimeters of Mercury | Standard Deviation 17.56 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | TOC, SBP | 2.1 Millimeters of Mercury | Standard Deviation 19.34 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | LFU, SBP | 4.7 Millimeters of Mercury | Standard Deviation 18.78 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline, DBP | 70.6 Millimeters of Mercury | Standard Deviation 12.9 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 2, DBP | 0.1 Millimeters of Mercury | Standard Deviation 11.31 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 3, DBP | 2.4 Millimeters of Mercury | Standard Deviation 12.77 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 4, DBP | 4.8 Millimeters of Mercury | Standard Deviation 15.13 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 5, DBP | 4.0 Millimeters of Mercury | Standard Deviation 13.9 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 6, DBP | 2.0 Millimeters of Mercury | Standard Deviation 16.36 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 7, DBP | 4.4 Millimeters of Mercury | Standard Deviation 17.53 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 8, DBP | 8.5 Millimeters of Mercury | Standard Deviation 14.9 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 9, DBP | 0.2 Millimeters of Mercury | Standard Deviation 21.05 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 10, DBP | -3.4 Millimeters of Mercury | Standard Deviation 23.1 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 11, DBP | 2.3 Millimeters of Mercury | Standard Deviation 24.8 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 12, DBP | -5.0 Millimeters of Mercury | Standard Deviation 23.3 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 13, DBP | -7.0 Millimeters of Mercury | Standard Deviation 32.19 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Day 14, DBP | -9.5 Millimeters of Mercury | Standard Deviation 43.13 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | EOT, DBP | 0.7 Millimeters of Mercury | Standard Deviation 12.74 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | TOC, DBP | 2.9 Millimeters of Mercury | Standard Deviation 13.26 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | LFU, DBP | 3.4 Millimeters of Mercury | Standard Deviation 13.86 |
Secondary
Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Temperature
Temperature was measured in a supine position, after the participant had rest for at least 5 minutes.
Time frame: Baseline, Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, and EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49
Population: Safety analysis set included all participants who received any amount of IV study intervention. Here, Number Analyzed signifies participants included in safety analysis set at EOT, TOC and LFU respectively. Here, Number Analyzed signifies participants evaluable for specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Temperature | Baseline | 37.01 Degree Celsius | Standard Deviation 0.643 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Temperature | Day 2 | 0.33 Degree Celsius | Standard Deviation 0.653 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Temperature | Day 3 | 0.09 Degree Celsius | Standard Deviation 0.65 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Temperature | Day 4 | -0.05 Degree Celsius | Standard Deviation 0.679 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Temperature | Day 5 | -0.12 Degree Celsius | Standard Deviation 0.659 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Temperature | Day 6 | -0.29 Degree Celsius | Standard Deviation 0.782 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Temperature | Day 7 | -0.20 Degree Celsius | Standard Deviation 0.846 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Temperature | Day 8 | -0.19 Degree Celsius | Standard Deviation 0.607 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Temperature | Day 9 | -0.12 Degree Celsius | Standard Deviation 0.698 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Temperature | Day 10 | -0.26 Degree Celsius | Standard Deviation 0.811 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Temperature | Day 11 | -0.30 Degree Celsius | Standard Deviation 0.739 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Temperature | Day 12 | 0.13 Degree Celsius | Standard Deviation 0.321 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Temperature | Day 13 | -0.27 Degree Celsius | Standard Deviation 0.493 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Temperature | Day 14 | -0.10 Degree Celsius | Standard Deviation 0.141 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Temperature | EOT | -0.38 Degree Celsius | Standard Deviation 0.711 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Temperature | TOC | -0.58 Degree Celsius | Standard Deviation 0.766 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Temperature | LFU | -0.54 Degree Celsius | Standard Deviation 0.684 |
Secondary
Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Weight
Body weight was measured using a balance scale.
Time frame: Baseline, Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, and EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49
Population: Safety analysis set included all participants who received any amount of IV study intervention. Here, Number Analyzed signifies participants included in safety analysis set at EOT, TOC and LFU respectively. Here, Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Weight | Baseline | 62.05 Kilograms | Standard Deviation 12.975 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Weight | Day 2 | 0.64 Kilograms | Standard Deviation 1.587 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Weight | Day 3 | 0.68 Kilograms | Standard Deviation 1.927 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Weight | Day 4 | 0.34 Kilograms | Standard Deviation 1.578 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Weight | Day 5 | 0.39 Kilograms | Standard Deviation 1.949 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Weight | Day 6 | 0.82 Kilograms | Standard Deviation 1.593 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Weight | Day 7 | 1.55 Kilograms | Standard Deviation 2.415 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Weight | Day 8 | 1.80 Kilograms | Standard Deviation 3.894 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Weight | Day 9 | 5.80 Kilograms | — |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Weight | Day 10 | 5.00 Kilograms | — |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Weight | Day 11 | 5.40 Kilograms | — |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Weight | Day 12 | -0.05 Kilograms | Standard Deviation 5.303 |
| PF-06947386 + Metronidazole | Change From Baseline in Vital Sign Parameters at Day 2 to 14, EOT, TOC and, LFU Visits: Weight | Day 13 | 1.35 Kilograms | Standard Deviation 4.455 |
Secondary
Number of Participants Who Discontinued Treatment and Study Due to Adverse Events
Number of participants who discontinued treatment and study due to adverse events is presented.
Time frame: Up to Day 49
Population: Safety analysis set included all participants who received any amount of IV study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06947386 + Metronidazole | Number of Participants Who Discontinued Treatment and Study Due to Adverse Events | Discontinued Treatment due to AE | 0 Participants |
| PF-06947386 + Metronidazole | Number of Participants Who Discontinued Treatment and Study Due to Adverse Events | Discontinued study due to AE | 2 Participants |
Secondary
Number of Participants With Clinical Response at EOT and LFU Visits: Microbiological Modified Intent-to-Treat (mMITT) Analysis Set
Clinical response: Clinical response of cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within the abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptoms of intra-abdominal infection; Indeterminate: Study data was not available for evaluation of efficacy for any reason. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion.
Time frame: EOT: 24 hours after last IV infusion; LFU: Any day from Day 42 to Day 49
Population: mMITT analysis set included all enrolled participant who met the disease definition of cIAI; received any amount of study drug and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06947386 + Metronidazole | Number of Participants With Clinical Response at EOT and LFU Visits: Microbiological Modified Intent-to-Treat (mMITT) Analysis Set | EOT, Clinical Cure | 38 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Clinical Response at EOT and LFU Visits: Microbiological Modified Intent-to-Treat (mMITT) Analysis Set | EOT, Clinical Failure | 4 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Clinical Response at EOT and LFU Visits: Microbiological Modified Intent-to-Treat (mMITT) Analysis Set | EOT, Indeterminate | 0 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Clinical Response at EOT and LFU Visits: Microbiological Modified Intent-to-Treat (mMITT) Analysis Set | LFU, Clinical Cure | 36 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Clinical Response at EOT and LFU Visits: Microbiological Modified Intent-to-Treat (mMITT) Analysis Set | LFU, Clinical Failure | 4 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Clinical Response at EOT and LFU Visits: Microbiological Modified Intent-to-Treat (mMITT) Analysis Set | LFU, Indeterminate | 2 Participants |
Secondary
Number of Participants With Clinical Response at EOT and LFU Visits: Modified Intent-to-Treat (MITT) Analysis Set
Clinical response: Clinical response of cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within the abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptoms of intra-abdominal infection; Indeterminate: Study data was not available for evaluation of efficacy for any reason. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion.
Time frame: EOT: 24 hours after last IV infusion; LFU: Any day from Day 42 to Day 49
Population: MITT analysis set included all enrolled participants who had clinical evidence of cIAI and received any amount of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06947386 + Metronidazole | Number of Participants With Clinical Response at EOT and LFU Visits: Modified Intent-to-Treat (MITT) Analysis Set | EOT, Clinical Cure | 54 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Clinical Response at EOT and LFU Visits: Modified Intent-to-Treat (MITT) Analysis Set | EOT, Clinical Failure | 4 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Clinical Response at EOT and LFU Visits: Modified Intent-to-Treat (MITT) Analysis Set | EOT, Indeterminate | 1 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Clinical Response at EOT and LFU Visits: Modified Intent-to-Treat (MITT) Analysis Set | LFU, Clinical Cure | 52 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Clinical Response at EOT and LFU Visits: Modified Intent-to-Treat (MITT) Analysis Set | LFU, Clinical Failure | 4 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Clinical Response at EOT and LFU Visits: Modified Intent-to-Treat (MITT) Analysis Set | LFU, Indeterminate | 3 Participants |
Secondary
Number of Participants With Laboratory Test Abnormalities
Criteria for abnormal laboratory values for chemistry parameters: Bilirubin \>1.5\*upper limit of normal (ULN), direct Bilirubin \>1.5\*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase \>3.0\*ULN, total protein and albumin \<0.8\*lower limit of normal (LLN), urea nitrogen and creatinine \>1.3\*ULN, sodium \>0.95\*LLN, potassium \>0.9\*LLN and \>1.1\*ULN, calcium \>0.9\*LLN, glucose \> 1.5\*LLN; hematology parameters: Hemoglobin, hematocrit, erythrocytes \<0.8\*LLN, platelets \<0.5\*LLN and \> 1.75\*ULN, leukocytes \<0.6\*LLN and \<0.6\*LLN, lymphocytes \<0.8\* LLN, lymphocytes/leukocytes \<0.8\* LLN and \>1.2\*ULN, neutrophils \>1.2\*ULN, neutrophils/leukocytes \<0.8\*LLN and \>1.2\* ULN, basophils/leukocytes \>1.2\*ULN, eosinophils \>1.2\*ULN, eosinophils/leukocytes \>1.2\*ULN, monocytes and monocytes/leukocytes \>1.2\*ULN; Criteria for abnormal laboratory values for urinalysis parameters: urine glucose, \>=1, urine protein \>=1, urine Hemoglobin\>=1.
Time frame: Up to Day 49
Population: Safety analysis set included all participants who received any amount of IV study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PF-06947386 + Metronidazole | Number of Participants With Laboratory Test Abnormalities | 60 Participants |
Secondary
Number of Participants With Microbiological Response EOT, TOC and LFU Visits: mMITT Analysis Set
Microbiological response: Favorable microbiological response assessments include eradication, presumed eradication and colonization. Unfavorable microbiological response assessments include persistence, persistence with increasing MIC, and presumed persistence. Indeterminate: Study data are not available for evaluation of efficacy. Indeterminate were not included in the denominator. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.
Time frame: EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49
Population: mMITT analysis set included all enrolled participant who met the disease definition of cIAI; received any amount of study drug and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06947386 + Metronidazole | Number of Participants With Microbiological Response EOT, TOC and LFU Visits: mMITT Analysis Set | EOT, Favorable | 38 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Microbiological Response EOT, TOC and LFU Visits: mMITT Analysis Set | EOT, Unfavorable | 4 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Microbiological Response EOT, TOC and LFU Visits: mMITT Analysis Set | EOT, Indeterminate | 0 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Microbiological Response EOT, TOC and LFU Visits: mMITT Analysis Set | TOC, Favorable | 36 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Microbiological Response EOT, TOC and LFU Visits: mMITT Analysis Set | TOC, Unfavorable | 4 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Microbiological Response EOT, TOC and LFU Visits: mMITT Analysis Set | TOC, Indeterminate | 2 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Microbiological Response EOT, TOC and LFU Visits: mMITT Analysis Set | LFU, Favorable | 36 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Microbiological Response EOT, TOC and LFU Visits: mMITT Analysis Set | LFU, Unfavorable | 4 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Microbiological Response EOT, TOC and LFU Visits: mMITT Analysis Set | LFU, Indeterminate | 2 Participants |
Secondary
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs (SAEs)
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was defined as any untoward medical occurrence that, at any dose that resulted in death, was life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent disability/incapacity, a congenital anomaly/birth defect as per medical or scientific judgment. AEs included both SAEs and non-SAEs. TEAE was defined as an AE that emerges or worsened during the effective duration of treatment. All events that started on or after the first dosing day were flagged as TEAEs.
Time frame: Up to Day 49
Population: Safety analysis set included all participants who received any amount of IV study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06947386 + Metronidazole | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs (SAEs) | AEs | 42 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs (SAEs) | SAEs | 3 Participants |
Secondary
Percentage of Participants With Clinical Response at End of Treatment (EOT) and Late Follow-up (LFU) Visits: CE Analysis Set
Clinical response: Clinical response of cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within the abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptoms of intra-abdominal infection; Indeterminate: Study data was not available for evaluation of efficacy for any reason. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion.
Time frame: EOT: 24 hours after last IV infusion; LFU: Any day from Day 42 to Day 49
Population: CE analysis set evaluated. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. Here, Number Analyzed signifies participants included in CE analysis set at EOT and LFU respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-06947386 + Metronidazole | Percentage of Participants With Clinical Response at End of Treatment (EOT) and Late Follow-up (LFU) Visits: CE Analysis Set | EOT, Clinical Cure | 90.5 Percentage of participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Clinical Response at End of Treatment (EOT) and Late Follow-up (LFU) Visits: CE Analysis Set | EOT, Clinical Failure | 9.5 Percentage of participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Clinical Response at End of Treatment (EOT) and Late Follow-up (LFU) Visits: CE Analysis Set | EOT, Indeterminate | 0 Percentage of participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Clinical Response at End of Treatment (EOT) and Late Follow-up (LFU) Visits: CE Analysis Set | LFU, Clinical Cure | 90.0 Percentage of participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Clinical Response at End of Treatment (EOT) and Late Follow-up (LFU) Visits: CE Analysis Set | LFU, Clinical Failure | 10.0 Percentage of participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Clinical Response at End of Treatment (EOT) and Late Follow-up (LFU) Visits: CE Analysis Set | LFU, Indeterminate | 0 Percentage of participants |
Secondary
Percentage of Participants With Clinical Response at EOT and LFU Visits: Microbiologically Evaluable (ME) Analysis Set
Clinical response: Clinical response of cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within the abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptoms of intra-abdominal infection; Indeterminate: Study data was not available for evaluation of efficacy for any reason. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion.
Time frame: EOT: 24 hours after last IV infusion; LFU: Any day from Day 42 to Day 49
Population: ME analysis set included participants who were included in a subset of CE participants and had at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible. Here, Number Analyzed signifies participants included in ME analysis set at EOT and LFU respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-06947386 + Metronidazole | Percentage of Participants With Clinical Response at EOT and LFU Visits: Microbiologically Evaluable (ME) Analysis Set | EOT, Clinical Cure | 94.4 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Clinical Response at EOT and LFU Visits: Microbiologically Evaluable (ME) Analysis Set | EOT, Clinical Failure | 5.6 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Clinical Response at EOT and LFU Visits: Microbiologically Evaluable (ME) Analysis Set | EOT, Indeterminate | 0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Clinical Response at EOT and LFU Visits: Microbiologically Evaluable (ME) Analysis Set | LFU, Clinical Cure | 94.3 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Clinical Response at EOT and LFU Visits: Microbiologically Evaluable (ME) Analysis Set | LFU, Clinical Failure | 5.7 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Clinical Response at EOT and LFU Visits: Microbiologically Evaluable (ME) Analysis Set | LFU, Indeterminate | 0 Percentage of Participants |
Secondary
Percentage of Participants With Clinical Response EOT and LFU Visits: Extended Microbiologically Evaluable (eME) Analysis Set
Clinical response: Clinical response of cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within the abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptoms of intra-abdominal infection; Indeterminate: Study data was not available for evaluation of efficacy for any reason. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion.
Time frame: EOT: 24 hours after last IV infusion; LFU: Any day from Day 42 to Day 49
Population: eME analysis set included participants who were included in a subset of CE participants and had at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that is susceptible. Here, Number Analyzed signifies participants included in eME analysis set at EOT and LFU respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-06947386 + Metronidazole | Percentage of Participants With Clinical Response EOT and LFU Visits: Extended Microbiologically Evaluable (eME) Analysis Set | EOT, Clinical Cure | 94.6 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Clinical Response EOT and LFU Visits: Extended Microbiologically Evaluable (eME) Analysis Set | EOT, Clinical Failure | 5.4 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Clinical Response EOT and LFU Visits: Extended Microbiologically Evaluable (eME) Analysis Set | EOT, Indeterminate | 0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Clinical Response EOT and LFU Visits: Extended Microbiologically Evaluable (eME) Analysis Set | LFU, Clinical Cure | 94.4 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Clinical Response EOT and LFU Visits: Extended Microbiologically Evaluable (eME) Analysis Set | LFU, Clinical Failure | 5.6 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Clinical Response EOT and LFU Visits: Extended Microbiologically Evaluable (eME) Analysis Set | LFU, Indeterminate | 0 Percentage of Participants |
Secondary
Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: eME Analysis Set
Microbiological response: Favorable microbiological response assessments include eradication, presumed eradication and colonization. Unfavorable microbiological response assessments include persistence, persistence with increasing MIC, and presumed persistence. Indeterminate: Study data was not available for evaluation of efficacy. Indeterminate were not included in the denominator. EOT: within 24 hours after completion of last IV infusion. Response of baseline pathogens cultured from intra-abdominal site or blood. A participant can have more than 1 pathogen. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.
Time frame: EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49
Population: eME analysis set: participants who were included in subset of CE participants \& had at least 1 Gram-negative aerobic pathogen in initial/prestudy culture that is susceptible. Overall Number of Participants Analyzed:participants evaluable for this outcome measure however all participants reported under 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Number Analyzed: participants included in eME analysis set at EOT, TOC \& LFU.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: eME Analysis Set | EOT, Enterobacter Aerogenes | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: eME Analysis Set | EOT, Escherichia Coli | 93.5 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: eME Analysis Set | EOT, Klebsiella Oxytoca | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: eME Analysis Set | EOT, Klebsiella Pneumoniae | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: eME Analysis Set | EOT, Proteus Mirabilis | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: eME Analysis Set | EOT, Proteus Penneri | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: eME Analysis Set | EOT, Proteus Vulgaris | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: eME Analysis Set | EOT, Raoultella Planticola | 50.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: eME Analysis Set | EOT, Pseudomonas Aeruginosa | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: eME Analysis Set | TOC, Enterobacter Aerogenes | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: eME Analysis Set | TOC, Escherichia Coli | 93.3 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: eME Analysis Set | TOC, Klebsiella Oxytoca | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: eME Analysis Set | TOC, Klebsiella Pneumoniae | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: eME Analysis Set | TOC, Proteus Mirabilis | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: eME Analysis Set | TOC, Proteus Penneri | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: eME Analysis Set | TOC, Proteus Vulgaris | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: eME Analysis Set | TOC, Raoultella Planticola | 0.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: eME Analysis Set | TOC, Pseudomonas Aeruginosa | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: eME Analysis Set | LFU, Enterobacter Aerogenes | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: eME Analysis Set | LFU, Escherichia Coli | 93.3 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: eME Analysis Set | LFU, Klebsiella Oxytoca | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: eME Analysis Set | LFU, Klebsiella Pneumoniae | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: eME Analysis Set | LFU, Proteus Mirabilis | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: eME Analysis Set | LFU, Proteus Penneri | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: eME Analysis Set | LFU, Proteus Vulgaris | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: eME Analysis Set | LFU, Raoultella Planticola | 0.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: eME Analysis Set | LFU, Pseudomonas Aeruginosa | 100.0 Percentage of Participants |
Secondary
Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: ME Analysis Set
Microbiological response: Favorable microbiological response assessments include eradication, presumed eradication and colonization. Unfavorable microbiological response assessments include persistence, persistence with increasing MIC, and presumed persistence. Indeterminate: Study data are not available for evaluation of efficacy. Indeterminate were not included in the denominator. EOT: within 24 hours after completion of last IV infusion. Response of baseline pathogens cultured from intra-abdominal site or blood. A participant can have more than 1 pathogen. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.
Time frame: EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49
Population: ME analysis set: participants who were included in subset of CE participants \& had at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible. Overall Number of Participants Analyzed:participants evaluable for this outcome measure however all participants reported under 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Number Analyzed:participants included in ME analysis set at EOT,TOC \& LFU
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: ME Analysis Set | EOT, Enterobacter Aerogenes | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: ME Analysis Set | EOT, Escherichia Coli | 93.5 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: ME Analysis Set | EOT, Klebsiella Oxytoca | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: ME Analysis Set | EOT, Klebsiella Pneumoniae | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: ME Analysis Set | EOT, Proteus Mirabilis | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: ME Analysis Set | EOT, Proteus Penneri | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: ME Analysis Set | EOT, Proteus Vulgaris | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: ME Analysis Set | EOT, Raoultella Planticola | 50.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: ME Analysis Set | EOT, Pseudomonas Aeruginosa | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: ME Analysis Set | TOC, Enterobacter Aerogenes | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: ME Analysis Set | TOC, Escherichia Coli | 93.3 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: ME Analysis Set | TOC, Klebsiella Oxytoca | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: ME Analysis Set | TOC, Klebsiella Pneumoniae | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: ME Analysis Set | TOC, Proteus Mirabilis | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: ME Analysis Set | TOC, Proteus Penneri | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: ME Analysis Set | TOC, Proteus Vulgaris | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: ME Analysis Set | TOC, Raoultella Planticola | 0.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: ME Analysis Set | TOC, Pseudomonas Aeruginosa | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: ME Analysis Set | LFU, Enterobacter Aerogenes | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: ME Analysis Set | LFU, Escherichia Coli | 93.3 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: ME Analysis Set | LFU, Klebsiella Oxytoca | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: ME Analysis Set | LFU, Klebsiella Pneumoniae | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: ME Analysis Set | LFU, Proteus Mirabilis | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: ME Analysis Set | LFU, Proteus Penneri | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: ME Analysis Set | LFU, Proteus Vulgaris | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: ME Analysis Set | LFU, Raoultella Planticola | 0.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: ME Analysis Set | LFU, Pseudomonas Aeruginosa | 100.0 Percentage of Participants |
Secondary
Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: mMITT Analysis Set
Microbiological response: Favorable microbiological response assessments include eradication, presumed eradication and colonization. Unfavorable microbiological response assessments include persistence, persistence with increasing MIC, and presumed persistence. Indeterminate: Study data was not available for evaluation of efficacy. Indeterminate were not included in the denominator. EOT: within 24 hours after completion of last IV infusion. Response of baseline pathogens cultured from intra-abdominal site or blood. A participant can have more than 1 pathogen. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.
Time frame: EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49
Population: mMITT analysis set:all enrolled participant who met disease definition of cIAI; received any amount of study drug; had at least 1 etiologic pathogen identified at study entry.Overall Number of Participants Analyzed: participants evaluable for this outcome measure however all participants reported under 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Number Analyzed:participants included in eME analysis set at EOT, TOC \& LFU.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: mMITT Analysis Set | EOT, Enterobacter Aerogenes | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: mMITT Analysis Set | EOT, Escherichia Coli | 93.5 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: mMITT Analysis Set | EOT, Klebsiella Oxytoca | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: mMITT Analysis Set | EOT, Klebsiella Pneumoniae | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: mMITT Analysis Set | EOT, Proteus Mirabilis | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: mMITT Analysis Set | EOT, Proteus Penneri | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: mMITT Analysis Set | EOT, Proteus Vulgaris | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: mMITT Analysis Set | EOT, Raoultella Planticola | 50.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: mMITT Analysis Set | EOT, Pseudomonas Aeruginosa | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: mMITT Analysis Set | TOC, Enterobacter Aerogenes | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: mMITT Analysis Set | TOC, Escherichia Coli | 93.3 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: mMITT Analysis Set | TOC, Klebsiella Oxytoca | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: mMITT Analysis Set | TOC, Klebsiella Pneumoniae | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: mMITT Analysis Set | TOC, Proteus Mirabilis | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: mMITT Analysis Set | TOC, Proteus Penneri | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: mMITT Analysis Set | TOC, Proteus Vulgaris | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: mMITT Analysis Set | TOC, Raoultella Planticola | 0.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: mMITT Analysis Set | TOC, Pseudomonas Aeruginosa | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: mMITT Analysis Set | LFU, Enterobacter Aerogenes | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: mMITT Analysis Set | LFU, Escherichia Coli | 93.3 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: mMITT Analysis Set | LFU, Klebsiella Oxytoca | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: mMITT Analysis Set | LFU, Klebsiella Pneumoniae | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: mMITT Analysis Set | LFU, Proteus Mirabilis | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: mMITT Analysis Set | LFU, Proteus Penneri | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: mMITT Analysis Set | LFU, Proteus Vulgaris | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: mMITT Analysis Set | LFU, Raoultella Planticola | 0.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: mMITT Analysis Set | LFU, Pseudomonas Aeruginosa | 100.0 Percentage of Participants |
Secondary
Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: eME Analysis Set
Microbiological response: Favorable microbiological response assessments include eradication, presumed eradication and colonization. Unfavorable microbiological response assessments include persistence, persistence with increasing MIC, and presumed persistence. Indeterminate: Study data was not available for evaluation of efficacy. Indeterminate were not included in the denominator. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.
Time frame: EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49
Population: eME analysis set: participants who were included in subset of CE participants \& had at least 1 Gram-negative aerobic pathogen in initial/prestudy culture that is susceptible. Overall Number of Participants Analyzed:participants evaluable for this outcome measure however all participants reported under 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Number Analyzed: participants included in eME analysis set at EOT, TOC \& LFU.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: eME Analysis Set | EOT, Enterobacter Aerogenes, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: eME Analysis Set | EOT, Escherichia Coli, Susceptible | 93.3 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: eME Analysis Set | EOT, Klebsiella Oxytoca, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: eME Analysis Set | EOT, Klebsiella Pneumoniae, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: eME Analysis Set | EOT, Proteus Mirabilis, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: eME Analysis Set | EOT, Proteus Penneri, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: eME Analysis Set | EOT, Proteus Vulgaris, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: eME Analysis Set | EOT, Raoultella Planticola, Susceptible | 50.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: eME Analysis Set | EOT, Pseudomonas Aeruginosa, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: eME Analysis Set | TOC, Enterobacter Aerogenes, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: eME Analysis Set | TOC, Escherichia Coli, Susceptible | 93.1 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: eME Analysis Set | TOC, Klebsiella Oxytoca, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: eME Analysis Set | TOC, Klebsiella Pneumoniae, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: eME Analysis Set | TOC, Proteus Mirabilis, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: eME Analysis Set | TOC, Proteus Penneri, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: eME Analysis Set | TOC, Proteus Vulgaris, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: eME Analysis Set | TOC, Raoultella Planticola, Susceptible | 0.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: eME Analysis Set | TOC, Pseudomonas Aeruginosa, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: eME Analysis Set | LFU, Enterobacter Aerogenes, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: eME Analysis Set | LFU, Escherichia Coli, Susceptible | 93.1 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: eME Analysis Set | LFU, Klebsiella Oxytoca, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: eME Analysis Set | LFU, Klebsiella Pneumoniae, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: eME Analysis Set | LFU, Proteus Mirabilis, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: eME Analysis Set | LFU, Proteus Penneri, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: eME Analysis Set | LFU, Proteus Vulgaris, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: eME Analysis Set | LFU, Raoultella Planticola, Susceptible | 0.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: eME Analysis Set | LFU, Pseudomonas Aeruginosa, Susceptible | 100.0 Percentage of Participants |
Secondary
Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: ME Analysis Set
Microbiological response: Favorable microbiological response assessments include eradication, presumed eradication and colonization. Unfavorable microbiological response assessments include persistence, persistence with increasing MIC, and presumed persistence. Indeterminate: Study data was not available for evaluation of efficacy. Indeterminate were not included in the denominator. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.
Time frame: EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49
Population: ME analysis set: participants who were included in subset of CE participants \& had at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible. Overall Number of Participants Analyzed:participants evaluable for this outcome measure however all participants reported under 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Number Analyzed:participants included in ME analysis set at EOT,TOC \& LFU
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: ME Analysis Set | EOT, Enterobacter Aerogenes, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: ME Analysis Set | EOT, Escherichia Coli, Susceptible | 93.3 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: ME Analysis Set | EOT, Klebsiella Oxytoca, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: ME Analysis Set | EOT, Klebsiella Pneumoniae, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: ME Analysis Set | EOT, Proteus Mirabilis, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: ME Analysis Set | EOT, Proteus Penneri, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: ME Analysis Set | EOT, Proteus Vulgaris, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: ME Analysis Set | EOT, Raoultella Planticola, Susceptible | 50.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: ME Analysis Set | EOT, Pseudomonas Aeruginosa, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: ME Analysis Set | TOC, Enterobacter Aerogenes, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: ME Analysis Set | TOC, Escherichia Coli, Susceptible | 93.1 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: ME Analysis Set | TOC, Klebsiella Oxytoca, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: ME Analysis Set | TOC, Klebsiella Pneumoniae, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: ME Analysis Set | TOC, Proteus Mirabilis, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: ME Analysis Set | TOC, Proteus Penneri, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: ME Analysis Set | TOC, Proteus Vulgaris, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: ME Analysis Set | TOC, Raoultella Planticola, Susceptible | 0.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: ME Analysis Set | TOC, Pseudomonas Aeruginosa, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: ME Analysis Set | LFU, Enterobacter Aerogenes, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: ME Analysis Set | LFU, Escherichia Coli, Susceptible | 93.1 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: ME Analysis Set | LFU, Klebsiella Oxytoca, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: ME Analysis Set | LFU, Klebsiella Pneumoniae, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: ME Analysis Set | LFU, Proteus Mirabilis, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: ME Analysis Set | LFU, Proteus Penneri, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: ME Analysis Set | LFU, Proteus Vulgaris, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: ME Analysis Set | LFU, Raoultella Planticola, Susceptible | 0.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: ME Analysis Set | LFU, Pseudomonas Aeruginosa, Susceptible | 100.0 Percentage of Participants |
Secondary
Percentage of Participants With Favorable Per-Pathogen Microbiological Response by Minimum Inhibitory Concentration (MIC) Categories at EOT, TOC and LFU Visits: mMITT Analysis Set
Microbiological response: Favorable microbiological response assessments include eradication, presumed eradication and colonization. Unfavorable microbiological response assessments include persistence, persistence with increasing MIC, and presumed persistence. Indeterminate: Study data was not available for evaluation of efficacy. Indeterminate were not included in the denominator. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.
Time frame: EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49
Population: mMITT analysis set:all enrolled participant who met disease definition of cIAI; received any amount of study drug; had at least 1 etiologic pathogen identified at study entry.Overall Number of Participants Analyzed: participants evaluable for this outcome measure however all participants reported under 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Number Analyzed:participants included in eME analysis set at EOT, TOC \& LFU
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by Minimum Inhibitory Concentration (MIC) Categories at EOT, TOC and LFU Visits: mMITT Analysis Set | EOT, Enterobacter Aerogenes, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by Minimum Inhibitory Concentration (MIC) Categories at EOT, TOC and LFU Visits: mMITT Analysis Set | EOT, Escherichia Coli, Susceptible | 93.3 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by Minimum Inhibitory Concentration (MIC) Categories at EOT, TOC and LFU Visits: mMITT Analysis Set | EOT, Klebsiella Oxytoca, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by Minimum Inhibitory Concentration (MIC) Categories at EOT, TOC and LFU Visits: mMITT Analysis Set | EOT, Klebsiella Pneumoniae, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by Minimum Inhibitory Concentration (MIC) Categories at EOT, TOC and LFU Visits: mMITT Analysis Set | EOT, Proteus Mirabilis, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by Minimum Inhibitory Concentration (MIC) Categories at EOT, TOC and LFU Visits: mMITT Analysis Set | EOT, Proteus Penneri, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by Minimum Inhibitory Concentration (MIC) Categories at EOT, TOC and LFU Visits: mMITT Analysis Set | EOT, Proteus Vulgaris, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by Minimum Inhibitory Concentration (MIC) Categories at EOT, TOC and LFU Visits: mMITT Analysis Set | EOT, Raoultella Planticola, Susceptible | 50.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by Minimum Inhibitory Concentration (MIC) Categories at EOT, TOC and LFU Visits: mMITT Analysis Set | EOT, Pseudomonas Aeruginosa, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by Minimum Inhibitory Concentration (MIC) Categories at EOT, TOC and LFU Visits: mMITT Analysis Set | TOC, Enterobacter Aerogenes, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by Minimum Inhibitory Concentration (MIC) Categories at EOT, TOC and LFU Visits: mMITT Analysis Set | TOC, Escherichia Coli, Susceptible | 93.1 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by Minimum Inhibitory Concentration (MIC) Categories at EOT, TOC and LFU Visits: mMITT Analysis Set | TOC, Klebsiella Oxytoca, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by Minimum Inhibitory Concentration (MIC) Categories at EOT, TOC and LFU Visits: mMITT Analysis Set | TOC, Klebsiella Pneumoniae, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by Minimum Inhibitory Concentration (MIC) Categories at EOT, TOC and LFU Visits: mMITT Analysis Set | TOC, Proteus Mirabilis, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by Minimum Inhibitory Concentration (MIC) Categories at EOT, TOC and LFU Visits: mMITT Analysis Set | TOC, Proteus Penneri, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by Minimum Inhibitory Concentration (MIC) Categories at EOT, TOC and LFU Visits: mMITT Analysis Set | TOC, Proteus Vulgaris, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by Minimum Inhibitory Concentration (MIC) Categories at EOT, TOC and LFU Visits: mMITT Analysis Set | TOC, Raoultella Planticola, Susceptible | 0.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by Minimum Inhibitory Concentration (MIC) Categories at EOT, TOC and LFU Visits: mMITT Analysis Set | TOC, Pseudomonas Aeruginosa, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by Minimum Inhibitory Concentration (MIC) Categories at EOT, TOC and LFU Visits: mMITT Analysis Set | LFU, Enterobacter Aerogenes, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by Minimum Inhibitory Concentration (MIC) Categories at EOT, TOC and LFU Visits: mMITT Analysis Set | LFU, Escherichia Coli, Susceptible | 93.1 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by Minimum Inhibitory Concentration (MIC) Categories at EOT, TOC and LFU Visits: mMITT Analysis Set | LFU, Klebsiella Oxytoca, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by Minimum Inhibitory Concentration (MIC) Categories at EOT, TOC and LFU Visits: mMITT Analysis Set | LFU, Klebsiella Pneumoniae, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by Minimum Inhibitory Concentration (MIC) Categories at EOT, TOC and LFU Visits: mMITT Analysis Set | LFU, Proteus Mirabilis, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by Minimum Inhibitory Concentration (MIC) Categories at EOT, TOC and LFU Visits: mMITT Analysis Set | LFU, Proteus Penneri, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by Minimum Inhibitory Concentration (MIC) Categories at EOT, TOC and LFU Visits: mMITT Analysis Set | LFU, Proteus Vulgaris, Susceptible | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by Minimum Inhibitory Concentration (MIC) Categories at EOT, TOC and LFU Visits: mMITT Analysis Set | LFU, Raoultella Planticola, Susceptible | 0.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response by Minimum Inhibitory Concentration (MIC) Categories at EOT, TOC and LFU Visits: mMITT Analysis Set | LFU, Pseudomonas Aeruginosa, Susceptible | 100.0 Percentage of Participants |
Secondary
Percentage of Participants With Microbiological Response EOT, TOC and LFU Visits: eME Analysis Set
Microbiological response: Favorable microbiological response assessments include eradication, presumed eradication and colonization. Unfavorable microbiological response assessments include persistence, persistence with increasing MIC, and presumed persistence. Indeterminate: Study data was not available for evaluation of efficacy. Indeterminate were not included in the denominator. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.
Time frame: EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49
Population: eME analysis set included participants who were included in a subset of CE participants and had at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that is susceptible. Here, Number Analyzed signifies participants included in eME analysis set at EOT, TOC and LFU respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-06947386 + Metronidazole | Percentage of Participants With Microbiological Response EOT, TOC and LFU Visits: eME Analysis Set | EOT, Favorable | 94.6 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Microbiological Response EOT, TOC and LFU Visits: eME Analysis Set | EOT, Unfavorable | 5.4 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Microbiological Response EOT, TOC and LFU Visits: eME Analysis Set | EOT, Indeterminate | 0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Microbiological Response EOT, TOC and LFU Visits: eME Analysis Set | TOC, Favorable | 94.4 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Microbiological Response EOT, TOC and LFU Visits: eME Analysis Set | TOC, Unfavorable | 5.6 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Microbiological Response EOT, TOC and LFU Visits: eME Analysis Set | TOC, Indeterminate | 0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Microbiological Response EOT, TOC and LFU Visits: eME Analysis Set | LFU, Favorable | 94.4 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Microbiological Response EOT, TOC and LFU Visits: eME Analysis Set | LFU, Unfavorable | 5.6 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Microbiological Response EOT, TOC and LFU Visits: eME Analysis Set | LFU, Indeterminate | 0 Percentage of Participants |
Secondary
Percentage of Participants With Microbiological Response EOT, TOC and LFU Visits: ME Analysis Set
Microbiological response: Favorable microbiological response assessments include eradication, presumed eradication and colonization. Unfavorable microbiological response assessments include persistence, persistence with increasing MIC, and presumed persistence. Indeterminate: Study data was not available for evaluation of efficacy. Indeterminate were not included in the denominator. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.
Time frame: EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49
Population: ME analysis set included participants who were included in a subset of CE participants and had at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible. Here, Number Analyzed signifies participants included in ME analysis set at EOT, TOC and LFU respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-06947386 + Metronidazole | Percentage of Participants With Microbiological Response EOT, TOC and LFU Visits: ME Analysis Set | EOT, Favorable | 94.4 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Microbiological Response EOT, TOC and LFU Visits: ME Analysis Set | EOT, Unfavorable | 5.6 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Microbiological Response EOT, TOC and LFU Visits: ME Analysis Set | EOT, Indeterminate | 0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Microbiological Response EOT, TOC and LFU Visits: ME Analysis Set | TOC, Favorable | 94.3 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Microbiological Response EOT, TOC and LFU Visits: ME Analysis Set | TOC, Unfavorable | 5.7 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Microbiological Response EOT, TOC and LFU Visits: ME Analysis Set | TOC, Indeterminate | 0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Microbiological Response EOT, TOC and LFU Visits: ME Analysis Set | LFU, Favorable | 94.3 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Microbiological Response EOT, TOC and LFU Visits: ME Analysis Set | LFU, Unfavorable | 5.7 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Microbiological Response EOT, TOC and LFU Visits: ME Analysis Set | LFU, Indeterminate | 0 Percentage of Participants |
Secondary
Plasma Concentration of Avibactam
Plasma concentrations of avibactam was measured by nominal sampling window.
Time frame: Day 3, Day 4, and Combination of Day 3 and 4: 15 minutes before or after infusion, 30-90 minutes after infusion, 300-360 minutes after infusion
Population: Pharmacokinetic (PK) analysis set included all participants who have at least 1 plasma concentration data value available for either Ceftazidime or Avibactam. Overall number of participants analyzed signifies participants evaluable for this outcome measure. 'Number Analyzed' signifies participants evaluable for specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06947386 + Metronidazole | Plasma Concentration of Avibactam | Day 3, 15 minutes before or after | 13810 Nanograms per milliliter | Standard Deviation 5911.5 |
| PF-06947386 + Metronidazole | Plasma Concentration of Avibactam | Day 3, 30-90 minutes after | 8321 Nanograms per milliliter | Standard Deviation 3776.9 |
| PF-06947386 + Metronidazole | Plasma Concentration of Avibactam | Day 3, 300-360 minutes after | 1148 Nanograms per milliliter | Standard Deviation 708.04 |
| PF-06947386 + Metronidazole | Plasma Concentration of Avibactam | Day 4, 15 minutes before or after | 13940 Nanograms per milliliter | Standard Deviation 4352.1 |
| PF-06947386 + Metronidazole | Plasma Concentration of Avibactam | Day 4, 30-90 minutes after | 7897 Nanograms per milliliter | Standard Deviation 2926.5 |
| PF-06947386 + Metronidazole | Plasma Concentration of Avibactam | Day 4, 300-360 minutes after | 1651 Nanograms per milliliter | Standard Deviation 2195.6 |
| PF-06947386 + Metronidazole | Plasma Concentration of Avibactam | Day 3 and Day 4, 15 minutes before or after | 13870 Nanograms per milliliter | Standard Deviation 5240.9 |
| PF-06947386 + Metronidazole | Plasma Concentration of Avibactam | Day 3 and Day 4, 30-90 minutes after | 8098 Nanograms per milliliter | Standard Deviation 3332.2 |
| PF-06947386 + Metronidazole | Plasma Concentration of Avibactam | Day 3 and 4, 300-360 minutes after | 1382 Nanograms per milliliter | Standard Deviation 1589.6 |
Secondary
Plasma Concentration of Ceftazidime
Plasma concentrations of ceftazidime was measured by nominal sampling window.
Time frame: Day 3, Day 4, and Combination of Day 3 and 4: 15 minutes before or after infusion, 30-90 minutes after infusion, 300-360 minutes after infusion
Population: PK analysis set included all participants who have at least 1 plasma concentration data value available for either Ceftazidime or Avibactam. Overall number of participants analyzed signifies participants evaluable for this outcome measure. Here, Number Analyzed signifies participants evaluable for specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06947386 + Metronidazole | Plasma Concentration of Ceftazidime | Day 3, 30-90 minutes after | 48800 Nanograms per milliliter | Standard Deviation 16611 |
| PF-06947386 + Metronidazole | Plasma Concentration of Ceftazidime | Day 3, 300-360 minutes after | 10030 Nanograms per milliliter | Standard Deviation 5852.5 |
| PF-06947386 + Metronidazole | Plasma Concentration of Ceftazidime | Day 4, 30-90 minutes after | 49190 Nanograms per milliliter | Standard Deviation 13095 |
| PF-06947386 + Metronidazole | Plasma Concentration of Ceftazidime | Day 3, 15 minutes before or after | 72940 Nanograms per milliliter | Standard Deviation 21323 |
| PF-06947386 + Metronidazole | Plasma Concentration of Ceftazidime | Day 4, 15 minutes before or after | 76680 Nanograms per milliliter | Standard Deviation 26157 |
| PF-06947386 + Metronidazole | Plasma Concentration of Ceftazidime | Day 4, 300-360 minutes after | 13920 Nanograms per milliliter | Standard Deviation 13135 |
| PF-06947386 + Metronidazole | Plasma Concentration of Ceftazidime | Day 3 and Day 4, 15 minutes before or after | 74580 Nanograms per milliliter | Standard Deviation 23418 |
| PF-06947386 + Metronidazole | Plasma Concentration of Ceftazidime | Day 3 and Day 4, 30-90 minutes after | 49010 Nanograms per milliliter | Standard Deviation 14729 |
| PF-06947386 + Metronidazole | Plasma Concentration of Ceftazidime | Day 3 and Day 4, 300-360 minutes after | 11840 Nanograms per milliliter | Standard Deviation 10028 |
Other Pre-specified
Number of Participants With Clinical Response at EOT, TOC and LFU Visits: Sepsis Evaluable Participants Subset
Clinical response of cure was defined as complete resolution or significant improvement of signs & symptoms of index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from day of 1st IV infusion, allowed visit window was 28¬-35 calendar days after day of 1st IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptom of intra-abdominal infection; Indeterminate:Study data was not available for evaluation of efficacy for any reason. EOT: within 24 hours after completion of last IV infusion. LFU:after 42 calendar days from day of 1st IV infusion, allowed visit window was 42-49 calendar days from 1st IV infusion. TOC:after 28 calendar days from 1st IV infusion, allowed visit window was 28-35 calendar days after 1st IV infusion.
Time frame: EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49
Population: Sepsis evaluable participants subset: participants who satisfied both clinical and microbiological criteria; Clinical: at least one criteria at Baseline. 1) body temperature \>=38 degree Celsius or \<36 degree Celsius, 2) WBC \>12000 cells/mm3 or \<4000 cells/mm3, or immature neutrophil \>10%, 3) heart rate \>90 beats per minute (bpm), 4) SBP \<90mmHg, 5) C-reactive protein (CRP) \>=20 mg/dL. Microbiological: The most relevant pathogens isolated from blood at Baseline regardless of susceptibility.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06947386 + Metronidazole | Number of Participants With Clinical Response at EOT, TOC and LFU Visits: Sepsis Evaluable Participants Subset | EOT, Clinical Cure | 1 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Clinical Response at EOT, TOC and LFU Visits: Sepsis Evaluable Participants Subset | EOT, Clinical Failure | 0 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Clinical Response at EOT, TOC and LFU Visits: Sepsis Evaluable Participants Subset | EOT, Indeterminate | 0 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Clinical Response at EOT, TOC and LFU Visits: Sepsis Evaluable Participants Subset | TOC, Clinical Cure | 1 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Clinical Response at EOT, TOC and LFU Visits: Sepsis Evaluable Participants Subset | TOC, Clinical Failure | 0 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Clinical Response at EOT, TOC and LFU Visits: Sepsis Evaluable Participants Subset | TOC, Indeterminate | 0 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Clinical Response at EOT, TOC and LFU Visits: Sepsis Evaluable Participants Subset | LFU, Clinical Cure | 1 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Clinical Response at EOT, TOC and LFU Visits: Sepsis Evaluable Participants Subset | LFU, Clinical Failure | 0 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Clinical Response at EOT, TOC and LFU Visits: Sepsis Evaluable Participants Subset | LFU, Indeterminate | 0 Participants |
Other Pre-specified
Number of Participants With Clinical Response at EOT, TOC and LFU Visits: Sepsis Participants Subset
Clinical response of cure was defined as complete resolution or significant improvement of signs & symptoms of index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from day of 1st IV infusion, allowed visit window was 28¬-35 calendar days after day of 1st IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptom of intra-abdominal infection; Indeterminate:Study data was not available for evaluation of efficacy for any reason. EOT: within 24 hours after completion of last IV infusion. LFU:after 42 calendar days from day of 1st IV infusion, allowed visit window was 42-49 calendar days from 1st IV infusion. TOC:after 28 calendar days from 1st IV infusion, allowed visit window was 28-35 calendar days after 1st IV infusion.
Time frame: EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49
Population: Sepsis participants subset included participants who satisfied clinical \& microbiological criteria; total score \>=2 in Sequential Organ Failure Assessment (SOFA) for intensive care unit (ICU) participants, 2 items or more in quick SOFA (qSOFA) for non-ICU participants; most relevant pathogens (aerobic Gram-negative bacteria -either Enterobacterales or aerobic Gram-negative pathogens other than Enterobacterales) isolated from blood at Baseline regardless of susceptibility.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06947386 + Metronidazole | Number of Participants With Clinical Response at EOT, TOC and LFU Visits: Sepsis Participants Subset | EOT, Clinical Cure | 2 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Clinical Response at EOT, TOC and LFU Visits: Sepsis Participants Subset | EOT, Clinical Failure | 0 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Clinical Response at EOT, TOC and LFU Visits: Sepsis Participants Subset | EOT, Indeterminate | 0 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Clinical Response at EOT, TOC and LFU Visits: Sepsis Participants Subset | TOC, Clinical Cure | 2 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Clinical Response at EOT, TOC and LFU Visits: Sepsis Participants Subset | TOC, Clinical Failure | 0 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Clinical Response at EOT, TOC and LFU Visits: Sepsis Participants Subset | TOC, Indeterminate | 0 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Clinical Response at EOT, TOC and LFU Visits: Sepsis Participants Subset | LFU, Clinical Cure | 2 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Clinical Response at EOT, TOC and LFU Visits: Sepsis Participants Subset | LFU, Clinical Failure | 0 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Clinical Response at EOT, TOC and LFU Visits: Sepsis Participants Subset | LFU, Indeterminate | 0 Participants |
Other Pre-specified
Number of Participants With Clinical Response at TOC: eME Analysis Set
Clinical response: Clinical response of cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within the abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptoms of intra-abdominal infection; Indeterminate: Study data was not available for evaluation of efficacy for any reason. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.
Time frame: TOC: Any day from Day 28 to Day 35
Population: eME analysis set included participants who were included in a subset of CE participants and had at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that is susceptible.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06947386 + Metronidazole | Number of Participants With Clinical Response at TOC: eME Analysis Set | TOC, Clinical Cure | 34 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Clinical Response at TOC: eME Analysis Set | TOC, Clinical Failure | 2 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Clinical Response at TOC: eME Analysis Set | TOC, Indeterminate | 0 Participants |
Other Pre-specified
Number of Participants With Clinical Response at TOC: ME Analysis Set
Clinical response: Clinical response of cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within the abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptoms of intra-abdominal infection; Indeterminate: Study data was not available for evaluation of efficacy for any reason. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.
Time frame: TOC: Any day from Day 28 to Day 35
Population: ME analysis set included participants who were included in a subset of CE participants and had at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06947386 + Metronidazole | Number of Participants With Clinical Response at TOC: ME Analysis Set | TOC, Clinical Cure | 33 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Clinical Response at TOC: ME Analysis Set | TOC, Clinical Failure | 2 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Clinical Response at TOC: ME Analysis Set | TOC, Indeterminate | 0 Participants |
Other Pre-specified
Number of Participants With Clinical Response at TOC Visit: MITT Analysis Set
Clinical response: Clinical response of cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within the abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptoms of intra-abdominal infection; Indeterminate: Study data was not available for evaluation of efficacy for any reason. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.
Time frame: TOC: Any day from Day 28 to Day 35
Population: MITT analysis set included all enrolled participants who had clinical evidence of cIAI.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06947386 + Metronidazole | Number of Participants With Clinical Response at TOC Visit: MITT Analysis Set | TOC, Clinical Cure | 52 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Clinical Response at TOC Visit: MITT Analysis Set | TOC, Clinical Failure | 4 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Clinical Response at TOC Visit: MITT Analysis Set | TOC, Indeterminate | 3 Participants |
Other Pre-specified
Number of Participants With Clinical Response at TOC Visit: mMITT Analysis Set
Clinical response: Clinical response of cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no further antimicrobial therapy, drainage, or surgical intervention was necessary. TOC was after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion; clinical failure: Death related to intra-abdominal infection, Persisting or recurrent infection within the abdomen, Postsurgical wound infections, participant who received treatment with additional antibiotics for ongoing symptoms of intra-abdominal infection; Indeterminate: Study data was not available for evaluation of efficacy for any reason. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.
Time frame: TOC: Any day from Day 28 to Day 35
Population: mMITT analysis set included all enrolled participant who met the disease definition of cIAI; received any amount of study drug and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06947386 + Metronidazole | Number of Participants With Clinical Response at TOC Visit: mMITT Analysis Set | TOC, Clinical Cure | 36 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Clinical Response at TOC Visit: mMITT Analysis Set | TOC, Clinical Failure | 4 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Clinical Response at TOC Visit: mMITT Analysis Set | TOC, Indeterminate | 2 Participants |
Other Pre-specified
Number of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: Sepsis Evaluation Participants Subset
Microbiological response: Favorable microbiological response assessments include eradication, presumed eradication and colonization. Unfavorable microbiological response assessments include persistence, persistence with increasing MIC, and presumed persistence. Indeterminate: Study data was not available for evaluation of efficacy. EOT: within 24 hours after completion of last IV infusion. Response of baseline pathogens cultured from intra-abdominal site or blood. A participant can have more than 1 pathogen. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.
Time frame: EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49
Population: Sepsis evaluable participants subset: participants who satisfied both clinical and microbiological criteria. Clinical: at least 1 criteria at Baseline, 1) body temperature \>=38 or \<36 degree Celsius, 2) WBC \>12000 or \<4000 cells/mm3, or immature neutrophil \>10%, 3) heart rate \>90 bpm, 4) SBP \<90 mmHg, 5) CRP \>=20 mg/dL. Microbiological: The most relevant pathogens isolated from blood at Baseline regardless of susceptibility.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06947386 + Metronidazole | Number of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: Sepsis Evaluation Participants Subset | EOT, Escherichia Coli | 1 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: Sepsis Evaluation Participants Subset | EOT, Klebsiella Pneumoniae | 1 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: Sepsis Evaluation Participants Subset | TOC, Escherichia Coli | 1 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: Sepsis Evaluation Participants Subset | TOC, Klebsiella Pneumoniae | 1 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: Sepsis Evaluation Participants Subset | LFU, Klebsiella Pneumoniae | 1 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: Sepsis Evaluation Participants Subset | LFU, Escherichia Coli | 1 Participants |
Other Pre-specified
Number of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: Sepsis Evaluation Participants Subset
Microbiological response: Favorable microbiological response assessments include eradication, presumed eradication and colonization. Unfavorable microbiological response assessments include persistence, persistence with increasing MIC, and presumed persistence. Indeterminate: Study data was not available for evaluation of efficacy. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.
Time frame: EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49
Population: Sepsis evaluable participants subset: participants who satisfied both clinical and microbiological criteria. Clinical: at least 1 criteria at Baseline, 1) body temperature \>=38 or \<36 degree Celsius, 2) WBC \>12000 or \<4000 cells/mm3, or immature neutrophil \>10%, 3) heart rate \>90 bpm, 4) SBP \<90 mmHg, 5) CRP \>=20 mg/dL. Microbiological: The most relevant pathogens isolated from blood at Baseline regardless of susceptibility.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06947386 + Metronidazole | Number of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: Sepsis Evaluation Participants Subset | EOT, Klebsiella Pneumoniae, Susceptible | 1 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: Sepsis Evaluation Participants Subset | TOC, Klebsiella Pneumoniae, Susceptible | 1 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: Sepsis Evaluation Participants Subset | LFU, Klebsiella Pneumoniae, Susceptible | 1 Participants |
Other Pre-specified
Number of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: Sepsis Participants Subset
Microbiological response: Favorable microbiological response assessments include eradication, presumed eradication and colonization. Unfavorable microbiological response assessments include persistence, persistence with increasing MIC, and presumed persistence. Indeterminate: Study data was not available for evaluation of efficacy. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.
Time frame: EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49
Population: Sepsis participants subset: participants who satisfied clinical \& microbiological criteria: total score \>=2 in SOFA for ICU participants, 2 items or more in qSOFA for non-ICU participants; most relevant pathogens isolated from blood at Baseline regardless of susceptibility. Here, Number Analyzed signifies participants included in Sepsis participants subset at EOT and LFU respectively.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06947386 + Metronidazole | Number of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: Sepsis Participants Subset | EOT, Escherichia Coli, Susceptible | 1 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: Sepsis Participants Subset | EOT, Klebsiella Pneumoniae, Susceptible | 1 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: Sepsis Participants Subset | TOC, Escherichia Coli, Susceptible | 1 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: Sepsis Participants Subset | TOC, Klebsiella Pneumoniae, Susceptible | 1 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: Sepsis Participants Subset | LFU, Escherichia Coli, Susceptible | 1 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Favorable Per-Pathogen Microbiological Response by MIC Categories at EOT, TOC and LFU Visits: Sepsis Participants Subset | LFU, Klebsiella Pneumoniae, Susceptible | 1 Participants |
Other Pre-specified
Number of Participants With Microbiological Response EOT, TOC and LFU Visits: Sepsis Evaluable Participants Subset
Microbiological response: Favorable microbiological response assessments include eradication, presumed eradication and colonization. Unfavorable microbiological response assessments include persistence, persistence with increasing MIC, and presumed persistence. Indeterminate: Study data are not available for evaluation of efficacy. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.
Time frame: EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49
Population: Sepsis evaluable participants subset: participants who satisfied both clinical and microbiological criteria. Clinical: at least 1 criteria at Baseline, 1) body temperature \>=38 or \<36 degree Celsius, 2) WBC \>12000 or \<4000 cells/mm3, or immature neutrophil \>10%, 3) heart rate \>90 bpm, 4) SBP \<90 mmHg, 5) CRP \>=20 mg/dL. Microbiological: The most relevant pathogens isolated from blood at Baseline regardless of susceptibility.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06947386 + Metronidazole | Number of Participants With Microbiological Response EOT, TOC and LFU Visits: Sepsis Evaluable Participants Subset | EOT, Favorable | 1 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Microbiological Response EOT, TOC and LFU Visits: Sepsis Evaluable Participants Subset | EOT, Unfavorable | 0 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Microbiological Response EOT, TOC and LFU Visits: Sepsis Evaluable Participants Subset | EOT, Indeterminate | 0 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Microbiological Response EOT, TOC and LFU Visits: Sepsis Evaluable Participants Subset | TOC, Favorable | 1 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Microbiological Response EOT, TOC and LFU Visits: Sepsis Evaluable Participants Subset | TOC, Unfavorable | 0 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Microbiological Response EOT, TOC and LFU Visits: Sepsis Evaluable Participants Subset | TOC, Indeterminate | 0 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Microbiological Response EOT, TOC and LFU Visits: Sepsis Evaluable Participants Subset | LFU, Favorable | 1 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Microbiological Response EOT, TOC and LFU Visits: Sepsis Evaluable Participants Subset | LFU, Unfavorable | 0 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Microbiological Response EOT, TOC and LFU Visits: Sepsis Evaluable Participants Subset | LFU, Indeterminate | 0 Participants |
Other Pre-specified
Number of Participants With Microbiological Response EOT, TOC and LFU Visits: Sepsis Participants Subset
Microbiological response: Favorable microbiological response assessments include eradication, presumed eradication and colonization. Unfavorable microbiological response assessments include persistence, persistence with increasing MIC, and presumed persistence. Indeterminate: Study data are not available for evaluation of efficacy. EOT: within 24 hours after completion of last IV infusion. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.
Time frame: EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49
Population: Sepsis participants subset included participants who satisfied clinical \& microbiological criteria; total score \>=2 in SOFA for ICU participants, 2 items or more in qSOFA for non-ICU participants; most relevant pathogens (aerobic Gram-negative bacteria -either Enterobacterales or aerobic Gram-negative pathogens other than Enterobacterales) isolated from blood at Baseline regardless of susceptibility.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06947386 + Metronidazole | Number of Participants With Microbiological Response EOT, TOC and LFU Visits: Sepsis Participants Subset | EOT, Favorable | 2 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Microbiological Response EOT, TOC and LFU Visits: Sepsis Participants Subset | EOT, Unfavorable | 0 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Microbiological Response EOT, TOC and LFU Visits: Sepsis Participants Subset | EOT, Indeterminate | 0 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Microbiological Response EOT, TOC and LFU Visits: Sepsis Participants Subset | TOC, Favorable | 2 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Microbiological Response EOT, TOC and LFU Visits: Sepsis Participants Subset | TOC, Unfavorable | 0 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Microbiological Response EOT, TOC and LFU Visits: Sepsis Participants Subset | TOC, Indeterminate | 0 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Microbiological Response EOT, TOC and LFU Visits: Sepsis Participants Subset | LFU, Favorable | 2 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Microbiological Response EOT, TOC and LFU Visits: Sepsis Participants Subset | LFU, Unfavorable | 0 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Microbiological Response EOT, TOC and LFU Visits: Sepsis Participants Subset | LFU, Indeterminate | 0 Participants |
Other Pre-specified
Number of Participants With Treatment Emergent AEs and SAEs: Sepsis Evaluable Participants Subset
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was defined as any untoward medical occurrence that, at any dose that resulted in death, was life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent disability/incapacity, a congenital anomaly/birth defect as per medical or scientific judgment. AEs included both SAEs and non-SAEs. TEAE was defined as an AE that emerges or worsened during the effective duration of treatment. All events that started on or after the first dosing day were flagged as TEAEs.
Time frame: Up to Day 49
Population: Sepsis evaluable participants subset: participants who satisfied both clinical and microbiological criteria. Clinical: at least 1 criteria at Baseline, 1) body temperature \>=38 or \<36 degree Celsius, 2) WBC \>12000 or \<4000 cells/mm3, or immature neutrophil \>10%, 3) heart rate \>90 bpm, 4) SBP \<90 mmHg, 5) CRP \>=20 mg/dL. Microbiological: The most relevant pathogens isolated from blood at Baseline regardless of susceptibility.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06947386 + Metronidazole | Number of Participants With Treatment Emergent AEs and SAEs: Sepsis Evaluable Participants Subset | AEs | 1 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Treatment Emergent AEs and SAEs: Sepsis Evaluable Participants Subset | SAEs | 0 Participants |
Other Pre-specified
Number of Participants With Treatment Emergent AEs and SAEs: Sepsis Participants Subset
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was defined as any untoward medical occurrence that, at any dose that resulted in death, was life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent disability/incapacity, a congenital anomaly/birth defect as per medical or scientific judgment. AEs included both SAEs and non-SAEs. TEAE was defined as an AE that emerges or worsened during the effective duration of treatment. All events that started on or after the first dosing day were flagged as TEAEs.
Time frame: Up to Day 49
Population: Sepsis participants subset included participants who satisfied clinical \& microbiological criteria; total score \>=2 in SOFA for ICU participants, 2 items or more in qSOFA for non-ICU participants; most relevant pathogens (aerobic Gram-negative bacteria -either Enterobacterales or aerobic Gram-negative pathogens other than Enterobacterales) isolated from blood at Baseline regardless of susceptibility.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06947386 + Metronidazole | Number of Participants With Treatment Emergent AEs and SAEs: Sepsis Participants Subset | AEs | 2 Participants |
| PF-06947386 + Metronidazole | Number of Participants With Treatment Emergent AEs and SAEs: Sepsis Participants Subset | SAEs | 0 Participants |
Other Pre-specified
Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: Sepsis Participants Subset
Microbiological response: Favorable microbiological response assessments include eradication, presumed eradication and colonization. Unfavorable microbiological response assessments include persistence, persistence with increasing MIC, and presumed persistence. Indeterminate: Study data was not available for evaluation of efficacy. EOT: within 24 hours after completion of last IV infusion. Response of baseline pathogens cultured from intra-abdominal site or blood. A participant can have more than 1 pathogen. LFU: after 42 calendar days from the day of the first IV infusion, the allowed visit window was 42 to 49 calendar days from the day of the first IV infusion. TOC: after 28 calendar days from the day of the first IV infusion, allowed visit window was 28 to 35 calendar days after the day of the first IV infusion.
Time frame: EOT: 24 hours after last IV infusion; TOC: Any day from Day 28 to 35; LFU: Any day from Day 42 to Day 49
Population: Sepsis participants subset: participants who satisfied clinical \& microbiological criteria; total score \>=2 in SOFA for ICU participants, 2 items or more in qSOFA for non-ICU participants; most relevant pathogens (aerobic Gram-negative bacteria -either Enterobacterales or aerobic Gram-negative pathogens other than Enterobacterales) isolated from blood at Baseline regardless of susceptibility. Number Analyzed: participants included in Sepsis participants subset at EOT \& LFU respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: Sepsis Participants Subset | EOT, Escherichia Coli | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: Sepsis Participants Subset | EOT, Klebsiella Pneumoniae | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: Sepsis Participants Subset | TOC, Escherichia Coli | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: Sepsis Participants Subset | TOC, Klebsiella Pneumoniae | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: Sepsis Participants Subset | LFU, Escherichia Coli | 100.0 Percentage of Participants |
| PF-06947386 + Metronidazole | Percentage of Participants With Favorable Per-Pathogen Microbiological Response at EOT, TOC and LFU Visits: Sepsis Participants Subset | LFU, Klebsiella Pneumoniae | 100.0 Percentage of Participants |