Pneumonia, Pneumonia, Ventilator-Associated, Urinary Tract Infections
Conditions
Keywords
Carbapenem, Doripenem, Doribax, Nosocomial pneumonia, Intra-abdominal infections, Urinary tract infection
Brief summary
The purpose of this study is to understand the utilization patterns of doripenem in Asia Pacific, including the profile of the patients treated with carbapenems.
Detailed description
This is a Phase 4, prospective, open-label, non-comparative, multicenter study to characterize the usage of doripenem in selected hospitals in the Asia Pacific region. Doripenem belongs to the carbapenem class which is a broad-spectrum antibiotic given to treat patients with serious infections, such as pneumonia and complicated intra-abdominal infections. Physicians in the selected hospital or hospital unit will refer potential patients to the study team. Patients will include men and women 18 years of age and older, hospitalized either in the Intensive Care Unit (ICU) or ward, with a diagnosis of pneumonia, complicated intra-abdominal infections and complicated urinary tract infections. The study has 3 phases: a pretreatment phase with a 1-day screening/baseline visit, a treatment phase of 5 to 14 days, and a post-treatment phase consisting of an end-of-treatment (EOT)/early withdrawal visit to be conducted within 24 hours after the last dose of antimicrobial therapy, a test of cure (TOC) visit 7 to 14 days after EOT, a Day 28 visit, and a post-discharge visit 28 days after discharge from the hospital. Usage of Doripenem in terms of approved indications, mode of usage, duration of antibiotic therapy, and patient characteristics will be assessed. Safety will be assessed through monitoring for adverse events, serial physical examinations, and the collection of conventional laboratory data (chemistry panel, complete blood count with differential). Being a prospective study, patient data will be gathered as the patients are enrolled, starting with their present condition and following them until duration of the study. The study will not compare Doripenem with other antibiotics for the primary endpoint. One vial (500mg) of doripenem intravenously (by injection) every 8 hours for 5 to 14 days
Interventions
DRUGdoripenem
500mg vial by injection every 8 hours for 5 to 14 days
Sponsors
Johnson & Johnson (Hong Kong) Ltd.
Janssen Research & Development, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Patients hospitalized either in the ICU or ward, with a diagnosis of pneumonia, complicated abdominal infections, or complicated urinary tract infection using the protocol-defined Guidelines for Diagnosis
Exclusion criteria
* Pregnant or lactating females * Allergies to Doripenem or its derivatives * Infected by a bacteria that is resistant to Doripenem * Taking probenecid * Severe allergies to other antibiotics like penicillins, cephalosporins, or carbapenems * Severe kidney disease, in an unstable disease state and assessed as unlikely to survive until the study follow up period * Signs of severe sepsis with treatment failure with other carbapenems, who received other carbapenem within 2 weeks before first dose of study drug, and who has any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With the Usage of Doripenem as Per the Approved Indication | 5 to 14 days | Early onset of Nosocomial Pneumonia (NP) and Ventilator-Associated Pneumonia (VAP) is defined as less than 5 days after hospitalization and late onset of NP and VAP is defined as more than or equal to 5 days after hospitalization |
| Number of Participants With Different Mode of Usage of Doripenem | 5 to 14 days | — |
| Duration of Antibiotic Therapy | 5 to 14 days | Duration of doripenem and duration of doripenem plus oral antibiotics therapy |
| Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score | Baseline (Day -1) | APACHE II is a severity of disease classification system and the score will be determined in the participants admitted to the Intensive Care Unit upon study enrollment to help predict the risk of mortality for critically ill patients. It consists of, A: acute physiology score (APS; range, 0 to 4), B: age points (range, 0 \[less than or equal to 44\] to 6 \[greater than or equal to 75\]) and C: chronic health points (2 \[elective postoperative patient\] and 5 \[non-operative or emergency postoperative patient\]). Total APACHE II score is sum of A, B and C. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Readmitted to the Intensive Care Unit (ICU) Within 28 Days After End-of-treatment (EOT) | Within 28 days after EOT (Day 5 or Day 7 or Day 14) | — |
| Number of Participants Who Achieved Clinical Cure, Clinical Failure and Intermediate Outcome at End-of-treatment Visit (EOT) | Day 5 or Day 7 or Day 14 | — |
| Number of Participants Readmitted to the Hospital Within 28 Days After End-of-treatment (EOT) | Within 28 days after EOT (Day 5 or Day 7 or Day 14) | — |
| Number of Participants Who Achieved Clinical Cure, or Experienced Clinical Failure, Relapse or Intermediate Outcome at Test-of-cure (TOC) Visit | End-of-treatment (Day 5 or Day 7 or Day 14) plus 7 to 14 days | — |
| Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit | Day 5 or Day 7 or Day 14 | — |
| Medical Resource Utilization | From Baseline (Day -1) upto the duration of hospital stay of a participant | Medical resource utilization included length of hospital stay, length of intensive care unit (ICU) stay, duration of mechanical ventilation and time to discharge. |
Countries
Hong Kong, Indonesia, Malaysia, Singapore, Vietnam
Participant flow
Recruitment details
217 patients were enrolled at sites in Malaysia, Indonesia, Singapore, Vietnam and Hong Kong.
Pre-assignment details
217 patients were enrolled and 216 received study medication. 1 patient was enrolled but subsequently withdrew consent before receiving the study medication. 61 patients discontinued study medication prior to end of treatment.
Participants by arm
| Arm | Count |
|---|---|
| Nosocomial Pneumonia (NP) 500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days | 53 |
| Ventilator-Associated Pneumonia (VAP) 500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days | 77 |
| Complicated Urinary Tract Infection (cUTI) 500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days | 19 |
| Complicated Intra-abdominal Infection (cIAI) 500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days | 67 |
| Total | 216 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Ventilator-Associated Pneumonia (VAP) | Total | Nosocomial Pneumonia (NP) | Complicated Intra-abdominal Infection (cIAI) | Complicated Urinary Tract Infection (cUTI) |
|---|---|---|---|---|---|
| Age, Continuous | 44.4 years STANDARD_DEVIATION 19.17 | 49.5 years STANDARD_DEVIATION 17.88 | 54.1 years STANDARD_DEVIATION 17.52 | 49.2 years STANDARD_DEVIATION 16.13 | 58.2 years STANDARD_DEVIATION 13.23 |
| Patient's location in the hospital upon enrollment Intensive Care Unit (ICU) | 69 Participants | 137 Participants | 30 Participants | 29 Participants | 9 Participants |
| Patient's location in the hospital upon enrollment Missing | 0 Participants | 2 Participants | 0 Participants | 2 Participants | 0 Participants |
| Patient's location in the hospital upon enrollment Non -ICU | 8 Participants | 77 Participants | 23 Participants | 36 Participants | 10 Participants |
| Race/Ethnicity, Customized Aboriginal | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Chinese | 13 Participants | 56 Participants | 8 Participants | 28 Participants | 7 Participants |
| Race/Ethnicity, Customized Indian | 3 Participants | 7 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Malay | 44 Participants | 120 Participants | 33 Participants | 35 Participants | 8 Participants |
| Race/Ethnicity, Customized Others | 16 Participants | 30 Participants | 10 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Female | 19 Participants | 72 Participants | 16 Participants | 24 Participants | 13 Participants |
| Sex: Female, Male Male | 58 Participants | 144 Participants | 37 Participants | 43 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 27 / 53 | 38 / 77 | 11 / 19 | 32 / 67 |
| serious Total, serious adverse events | 22 / 53 | 24 / 77 | 3 / 19 | 15 / 67 |
Outcome results
Primary
Duration of Antibiotic Therapy
Duration of doripenem and duration of doripenem plus oral antibiotics therapy
Time frame: 5 to 14 days
Population: Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nosocomial Pneumonia (NP) | Duration of Antibiotic Therapy | Duration of doripenem therapy | 7.4 Days | Standard Deviation 3.51 |
| Nosocomial Pneumonia (NP) | Duration of Antibiotic Therapy | Duration of doripenem plus oral antibiotic therapy | 7.5 Days | Standard Deviation 3.57 |
| Ventilator-Associated Pneumonia (VAP) | Duration of Antibiotic Therapy | Duration of doripenem plus oral antibiotic therapy | 9.9 Days | Standard Deviation 6.07 |
| Ventilator-Associated Pneumonia (VAP) | Duration of Antibiotic Therapy | Duration of doripenem therapy | 9.2 Days | Standard Deviation 4.67 |
| Complicated Urinary Tract Infection (cUTI) | Duration of Antibiotic Therapy | Duration of doripenem therapy | 6.9 Days | Standard Deviation 2.46 |
| Complicated Urinary Tract Infection (cUTI) | Duration of Antibiotic Therapy | Duration of doripenem plus oral antibiotic therapy | 9.1 Days | Standard Deviation 3.94 |
| Complicated Intra-abdominal Infection (cIAI) | Duration of Antibiotic Therapy | Duration of doripenem therapy | 6.9 Days | Standard Deviation 2.86 |
| Complicated Intra-abdominal Infection (cIAI) | Duration of Antibiotic Therapy | Duration of doripenem plus oral antibiotic therapy | 8.3 Days | Standard Deviation 4.5 |
Primary
Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score
APACHE II is a severity of disease classification system and the score will be determined in the participants admitted to the Intensive Care Unit upon study enrollment to help predict the risk of mortality for critically ill patients. It consists of, A: acute physiology score (APS; range, 0 to 4), B: age points (range, 0 \[less than or equal to 44\] to 6 \[greater than or equal to 75\]) and C: chronic health points (2 \[elective postoperative patient\] and 5 \[non-operative or emergency postoperative patient\]). Total APACHE II score is sum of A, B and C.
Time frame: Baseline (Day -1)
Population: Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nosocomial Pneumonia (NP) | Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score | APACHE II score: less than or equal to 14 | 34 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score | APACHE II score: 15 to 19 | 8 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score | APACHE II score: 20 to 24 | 4 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score | APACHE II score: 25 to 29 | 2 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score | APACHE II score: greater than or equal to 30 | 1 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score | Missing | 4 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score | Missing | 0 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score | APACHE II score: 25 to 29 | 4 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score | APACHE II score: less than or equal to 14 | 50 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score | APACHE II score: 20 to 24 | 7 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score | APACHE II score: 15 to 19 | 15 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score | APACHE II score: greater than or equal to 30 | 1 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score | APACHE II score: 15 to 19 | 3 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score | APACHE II score: 20 to 24 | 1 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score | APACHE II score: 25 to 29 | 0 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score | Missing | 4 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score | APACHE II score: greater than or equal to 30 | 0 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score | APACHE II score: less than or equal to 14 | 11 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score | APACHE II score: greater than or equal to 30 | 0 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score | Missing | 1 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score | APACHE II score: 15 to 19 | 6 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score | APACHE II score: 25 to 29 | 0 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score | APACHE II score: less than or equal to 14 | 58 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score | APACHE II score: 20 to 24 | 2 Participants |
Primary
Number of Participants With Different Mode of Usage of Doripenem
Time frame: 5 to 14 days
Population: Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nosocomial Pneumonia (NP) | Number of Participants With Different Mode of Usage of Doripenem | Monotherapy | 41 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants With Different Mode of Usage of Doripenem | Combination Therapy | 12 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants With Different Mode of Usage of Doripenem | First Line Therapy | 16 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants With Different Mode of Usage of Doripenem | Second Line Therapy | 37 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants With Different Mode of Usage of Doripenem | Combination Therapy | 11 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants With Different Mode of Usage of Doripenem | First Line Therapy | 33 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants With Different Mode of Usage of Doripenem | Second Line Therapy | 44 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants With Different Mode of Usage of Doripenem | Monotherapy | 66 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants With Different Mode of Usage of Doripenem | First Line Therapy | 3 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants With Different Mode of Usage of Doripenem | Combination Therapy | 1 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants With Different Mode of Usage of Doripenem | Second Line Therapy | 16 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants With Different Mode of Usage of Doripenem | Monotherapy | 18 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants With Different Mode of Usage of Doripenem | Second Line Therapy | 37 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants With Different Mode of Usage of Doripenem | Combination Therapy | 5 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants With Different Mode of Usage of Doripenem | Monotherapy | 62 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants With Different Mode of Usage of Doripenem | First Line Therapy | 30 Participants |
Primary
Number of Participants With the Usage of Doripenem as Per the Approved Indication
Early onset of Nosocomial Pneumonia (NP) and Ventilator-Associated Pneumonia (VAP) is defined as less than 5 days after hospitalization and late onset of NP and VAP is defined as more than or equal to 5 days after hospitalization
Time frame: 5 to 14 days
Population: Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nosocomial Pneumonia (NP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Prostate Infection | 0 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Late onset of NP | 30 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Appendicitis | 0 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Appendiceal Abscess | 0 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Pyelonephritis | 0 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Post Procedural Bile Leak | 0 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Abdominal Abscess | 0 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Complicated lower urinary tract infection | 0 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Pyonephrosis | 0 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Early onset of NP | 23 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Urosepsis | 0 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Small Intestine Gangrene | 0 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Intestinal Perforation | 0 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Ileal Perforation | 0 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Gastrointestinal Stoma Complication | 0 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Early onset of VAP | 0 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Small Intestinal Perforation | 0 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Gastrointestinal Anastomotic Leak | 0 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Gastric Ulcer Perforation | 0 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Late onset of VAP | 0 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Peritonitis | 0 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Gastric Perforation | 0 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Gallbladder Empyema | 0 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Acute Pyelonephritis | 0 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Pelvic Abscess | 0 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Duodenal Ulcer Perforation | 0 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Diverticular Perforation | 0 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Emphysematous Pyelonephritis | 0 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Large Intestine Perforation | 0 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Cholecystitis Acute | 0 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Appendicitis Perforated | 0 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Small Intestinal Perforation | 0 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Small Intestine Gangrene | 0 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Late onset of NP | 0 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Early onset of NP | 0 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Early onset of VAP | 32 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Late onset of VAP | 45 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Acute Pyelonephritis | 0 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Emphysematous Pyelonephritis | 0 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Prostate Infection | 0 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Pyelonephritis | 0 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Pyonephrosis | 0 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Urosepsis | 0 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Complicated lower urinary tract infection | 0 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Abdominal Abscess | 0 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Appendiceal Abscess | 0 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Appendicitis | 0 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Appendicitis Perforated | 0 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Cholecystitis Acute | 0 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Diverticular Perforation | 0 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Duodenal Ulcer Perforation | 0 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Gallbladder Empyema | 0 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Gastric Perforation | 0 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Gastric Ulcer Perforation | 0 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Gastrointestinal Anastomotic Leak | 0 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Gastrointestinal Stoma Complication | 0 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Ileal Perforation | 0 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Intestinal Perforation | 0 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Large Intestine Perforation | 0 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Pelvic Abscess | 0 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Peritonitis | 0 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Post Procedural Bile Leak | 0 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Gastrointestinal Anastomotic Leak | 0 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Large Intestine Perforation | 0 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Emphysematous Pyelonephritis | 1 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Peritonitis | 0 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Gastrointestinal Stoma Complication | 0 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Pelvic Abscess | 0 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Late onset of NP | 0 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Gallbladder Empyema | 0 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Ileal Perforation | 0 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Appendicitis Perforated | 0 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Early onset of NP | 0 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Late onset of VAP | 0 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Pyonephrosis | 1 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Diverticular Perforation | 0 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Urosepsis | 2 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Gastric Perforation | 0 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Cholecystitis Acute | 0 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Intestinal Perforation | 0 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Complicated lower urinary tract infection | 2 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Acute Pyelonephritis | 11 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Pyelonephritis | 1 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Small Intestine Gangrene | 0 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Abdominal Abscess | 0 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Gastric Ulcer Perforation | 0 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Post Procedural Bile Leak | 0 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Early onset of VAP | 0 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Appendiceal Abscess | 0 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Duodenal Ulcer Perforation | 0 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Prostate Infection | 1 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Small Intestinal Perforation | 0 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Appendicitis | 0 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Abdominal Abscess | 2 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Emphysematous Pyelonephritis | 0 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Appendicitis Perforated | 24 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Large Intestine Perforation | 7 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Cholecystitis Acute | 1 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Acute Pyelonephritis | 0 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Small Intestine Gangrene | 1 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Diverticular Perforation | 2 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Duodenal Ulcer Perforation | 1 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Late onset of VAP | 0 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Gallbladder Empyema | 1 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Pelvic Abscess | 1 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Gastric Perforation | 4 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Early onset of VAP | 0 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Gastric Ulcer Perforation | 3 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Post Procedural Bile Leak | 1 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Gastrointestinal Anastomotic Leak | 2 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Late onset of NP | 0 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Gastrointestinal Stoma Complication | 1 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Peritonitis | 1 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Ileal Perforation | 2 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Pyonephrosis | 0 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Small Intestinal Perforation | 3 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Urosepsis | 0 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Pyelonephritis | 0 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Complicated lower urinary tract infection | 0 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Intestinal Perforation | 8 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Appendicitis | 1 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Prostate Infection | 0 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Early onset of NP | 0 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants With the Usage of Doripenem as Per the Approved Indication | Appendiceal Abscess | 1 Participants |
Secondary
Medical Resource Utilization
Medical resource utilization included length of hospital stay, length of intensive care unit (ICU) stay, duration of mechanical ventilation and time to discharge.
Time frame: From Baseline (Day -1) upto the duration of hospital stay of a participant
Population: Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Nosocomial Pneumonia (NP) | Medical Resource Utilization | Length of Intensive Care Unit (ICU) Stay | 8 Days | Full Range 14.4 |
| Nosocomial Pneumonia (NP) | Medical Resource Utilization | Time to Discharge | 13 Days | Full Range 15.23 |
| Nosocomial Pneumonia (NP) | Medical Resource Utilization | Length of hospital stay | 21 Days | Full Range 25.89 |
| Nosocomial Pneumonia (NP) | Medical Resource Utilization | Duration of Mechanical Ventilation | 6 Days | Full Range 11.88 |
| Ventilator-Associated Pneumonia (VAP) | Medical Resource Utilization | Length of hospital stay | 33 Days | Full Range 26.95 |
| Ventilator-Associated Pneumonia (VAP) | Medical Resource Utilization | Length of Intensive Care Unit (ICU) Stay | 17 Days | Full Range 16.34 |
| Ventilator-Associated Pneumonia (VAP) | Medical Resource Utilization | Duration of Mechanical Ventilation | 15 Days | Full Range 21.61 |
| Ventilator-Associated Pneumonia (VAP) | Medical Resource Utilization | Time to Discharge | 19 Days | Full Range 18.96 |
| Complicated Urinary Tract Infection (cUTI) | Medical Resource Utilization | Length of hospital stay | 13 Days | Full Range 12.19 |
| Complicated Urinary Tract Infection (cUTI) | Medical Resource Utilization | Duration of Mechanical Ventilation | 2 Days | Full Range 1.92 |
| Complicated Urinary Tract Infection (cUTI) | Medical Resource Utilization | Length of Intensive Care Unit (ICU) Stay | 4 Days | Full Range 9.76 |
| Complicated Urinary Tract Infection (cUTI) | Medical Resource Utilization | Time to Discharge | 8 Days | Full Range 7.72 |
| Complicated Intra-abdominal Infection (cIAI) | Medical Resource Utilization | Length of Intensive Care Unit (ICU) Stay | 7 Days | Full Range 10.21 |
| Complicated Intra-abdominal Infection (cIAI) | Medical Resource Utilization | Duration of Mechanical Ventilation | 4 Days | Full Range 9.3 |
| Complicated Intra-abdominal Infection (cIAI) | Medical Resource Utilization | Time to Discharge | 9 Days | Full Range 16.42 |
| Complicated Intra-abdominal Infection (cIAI) | Medical Resource Utilization | Length of hospital stay | 12 Days | Full Range 17.6 |
Secondary
Number of Participants Readmitted to the Hospital Within 28 Days After End-of-treatment (EOT)
Time frame: Within 28 days after EOT (Day 5 or Day 7 or Day 14)
Population: Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nosocomial Pneumonia (NP) | Number of Participants Readmitted to the Hospital Within 28 Days After End-of-treatment (EOT) | Participants discharged from hospital | 30 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants Readmitted to the Hospital Within 28 Days After End-of-treatment (EOT) | Participants readmitted to hospital | 2 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants Readmitted to the Hospital Within 28 Days After End-of-treatment (EOT) | Participants readmitted to hospital | 4 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants Readmitted to the Hospital Within 28 Days After End-of-treatment (EOT) | Participants discharged from hospital | 44 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants Readmitted to the Hospital Within 28 Days After End-of-treatment (EOT) | Participants discharged from hospital | 18 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants Readmitted to the Hospital Within 28 Days After End-of-treatment (EOT) | Participants readmitted to hospital | 1 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants Readmitted to the Hospital Within 28 Days After End-of-treatment (EOT) | Participants discharged from hospital | 54 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants Readmitted to the Hospital Within 28 Days After End-of-treatment (EOT) | Participants readmitted to hospital | 0 Participants |
Secondary
Number of Participants Readmitted to the Intensive Care Unit (ICU) Within 28 Days After End-of-treatment (EOT)
Time frame: Within 28 days after EOT (Day 5 or Day 7 or Day 14)
Population: Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nosocomial Pneumonia (NP) | Number of Participants Readmitted to the Intensive Care Unit (ICU) Within 28 Days After End-of-treatment (EOT) | Participant still in hospital | 8 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants Readmitted to the Intensive Care Unit (ICU) Within 28 Days After End-of-treatment (EOT) | Participant readmitted in ICU | 0 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants Readmitted to the Intensive Care Unit (ICU) Within 28 Days After End-of-treatment (EOT) | Participant readmitted in ICU | 1 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants Readmitted to the Intensive Care Unit (ICU) Within 28 Days After End-of-treatment (EOT) | Participant still in hospital | 19 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants Readmitted to the Intensive Care Unit (ICU) Within 28 Days After End-of-treatment (EOT) | Participant readmitted in ICU | 0 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants Readmitted to the Intensive Care Unit (ICU) Within 28 Days After End-of-treatment (EOT) | Participant still in hospital | 1 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants Readmitted to the Intensive Care Unit (ICU) Within 28 Days After End-of-treatment (EOT) | Participant still in hospital | 6 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants Readmitted to the Intensive Care Unit (ICU) Within 28 Days After End-of-treatment (EOT) | Participant readmitted in ICU | 0 Participants |
Secondary
Number of Participants Who Achieved Clinical Cure, Clinical Failure and Intermediate Outcome at End-of-treatment Visit (EOT)
Time frame: Day 5 or Day 7 or Day 14
Population: Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nosocomial Pneumonia (NP) | Number of Participants Who Achieved Clinical Cure, Clinical Failure and Intermediate Outcome at End-of-treatment Visit (EOT) | Clinical cure | 33 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants Who Achieved Clinical Cure, Clinical Failure and Intermediate Outcome at End-of-treatment Visit (EOT) | Clinical failure | 7 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants Who Achieved Clinical Cure, Clinical Failure and Intermediate Outcome at End-of-treatment Visit (EOT) | Indeterminate outcome | 5 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants Who Achieved Clinical Cure, Clinical Failure and Intermediate Outcome at End-of-treatment Visit (EOT) | Missing data | 8 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants Who Achieved Clinical Cure, Clinical Failure and Intermediate Outcome at End-of-treatment Visit (EOT) | Clinical failure | 7 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants Who Achieved Clinical Cure, Clinical Failure and Intermediate Outcome at End-of-treatment Visit (EOT) | Indeterminate outcome | 15 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants Who Achieved Clinical Cure, Clinical Failure and Intermediate Outcome at End-of-treatment Visit (EOT) | Missing data | 6 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants Who Achieved Clinical Cure, Clinical Failure and Intermediate Outcome at End-of-treatment Visit (EOT) | Clinical cure | 49 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants Who Achieved Clinical Cure, Clinical Failure and Intermediate Outcome at End-of-treatment Visit (EOT) | Indeterminate outcome | 1 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants Who Achieved Clinical Cure, Clinical Failure and Intermediate Outcome at End-of-treatment Visit (EOT) | Clinical failure | 2 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants Who Achieved Clinical Cure, Clinical Failure and Intermediate Outcome at End-of-treatment Visit (EOT) | Missing data | 1 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants Who Achieved Clinical Cure, Clinical Failure and Intermediate Outcome at End-of-treatment Visit (EOT) | Clinical cure | 15 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants Who Achieved Clinical Cure, Clinical Failure and Intermediate Outcome at End-of-treatment Visit (EOT) | Missing data | 5 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants Who Achieved Clinical Cure, Clinical Failure and Intermediate Outcome at End-of-treatment Visit (EOT) | Clinical failure | 6 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants Who Achieved Clinical Cure, Clinical Failure and Intermediate Outcome at End-of-treatment Visit (EOT) | Clinical cure | 46 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants Who Achieved Clinical Cure, Clinical Failure and Intermediate Outcome at End-of-treatment Visit (EOT) | Indeterminate outcome | 10 Participants |
Secondary
Number of Participants Who Achieved Clinical Cure, or Experienced Clinical Failure, Relapse or Intermediate Outcome at Test-of-cure (TOC) Visit
Time frame: End-of-treatment (Day 5 or Day 7 or Day 14) plus 7 to 14 days
Population: Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nosocomial Pneumonia (NP) | Number of Participants Who Achieved Clinical Cure, or Experienced Clinical Failure, Relapse or Intermediate Outcome at Test-of-cure (TOC) Visit | Relapse | 1 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants Who Achieved Clinical Cure, or Experienced Clinical Failure, Relapse or Intermediate Outcome at Test-of-cure (TOC) Visit | Missing data | 22 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants Who Achieved Clinical Cure, or Experienced Clinical Failure, Relapse or Intermediate Outcome at Test-of-cure (TOC) Visit | Clinical cure | 25 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants Who Achieved Clinical Cure, or Experienced Clinical Failure, Relapse or Intermediate Outcome at Test-of-cure (TOC) Visit | Indeterminate outcome | 4 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants Who Achieved Clinical Cure, or Experienced Clinical Failure, Relapse or Intermediate Outcome at Test-of-cure (TOC) Visit | Clinical failure | 1 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants Who Achieved Clinical Cure, or Experienced Clinical Failure, Relapse or Intermediate Outcome at Test-of-cure (TOC) Visit | Relapse | 5 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants Who Achieved Clinical Cure, or Experienced Clinical Failure, Relapse or Intermediate Outcome at Test-of-cure (TOC) Visit | Clinical failure | 5 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants Who Achieved Clinical Cure, or Experienced Clinical Failure, Relapse or Intermediate Outcome at Test-of-cure (TOC) Visit | Missing data | 20 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants Who Achieved Clinical Cure, or Experienced Clinical Failure, Relapse or Intermediate Outcome at Test-of-cure (TOC) Visit | Clinical cure | 39 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants Who Achieved Clinical Cure, or Experienced Clinical Failure, Relapse or Intermediate Outcome at Test-of-cure (TOC) Visit | Indeterminate outcome | 8 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants Who Achieved Clinical Cure, or Experienced Clinical Failure, Relapse or Intermediate Outcome at Test-of-cure (TOC) Visit | Clinical failure | 2 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants Who Achieved Clinical Cure, or Experienced Clinical Failure, Relapse or Intermediate Outcome at Test-of-cure (TOC) Visit | Missing data | 3 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants Who Achieved Clinical Cure, or Experienced Clinical Failure, Relapse or Intermediate Outcome at Test-of-cure (TOC) Visit | Indeterminate outcome | 1 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants Who Achieved Clinical Cure, or Experienced Clinical Failure, Relapse or Intermediate Outcome at Test-of-cure (TOC) Visit | Relapse | 1 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants Who Achieved Clinical Cure, or Experienced Clinical Failure, Relapse or Intermediate Outcome at Test-of-cure (TOC) Visit | Clinical cure | 12 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants Who Achieved Clinical Cure, or Experienced Clinical Failure, Relapse or Intermediate Outcome at Test-of-cure (TOC) Visit | Missing data | 14 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants Who Achieved Clinical Cure, or Experienced Clinical Failure, Relapse or Intermediate Outcome at Test-of-cure (TOC) Visit | Clinical cure | 46 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants Who Achieved Clinical Cure, or Experienced Clinical Failure, Relapse or Intermediate Outcome at Test-of-cure (TOC) Visit | Clinical failure | 3 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants Who Achieved Clinical Cure, or Experienced Clinical Failure, Relapse or Intermediate Outcome at Test-of-cure (TOC) Visit | Relapse | 0 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants Who Achieved Clinical Cure, or Experienced Clinical Failure, Relapse or Intermediate Outcome at Test-of-cure (TOC) Visit | Indeterminate outcome | 4 Participants |
Secondary
Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit
Time frame: Day 5 or Day 7 or Day 14
Population: Microbiological Modified Intent-to-Treat Population (mMITT): included participants who had a baseline pathogen identified, regardless of susceptibility to study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nosocomial Pneumonia (NP) | Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit | Eradication | 7 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit | Presumed eradication | 10 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit | Persistence | 0 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit | Presumed persistence | 3 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit | Indeterminate | 3 Participants |
| Nosocomial Pneumonia (NP) | Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit | Missing data | 3 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit | Missing data | 5 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit | Presumed persistence | 4 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit | Eradication | 12 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit | Persistence | 14 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit | Presumed eradication | 18 Participants |
| Ventilator-Associated Pneumonia (VAP) | Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit | Indeterminate | 10 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit | Presumed eradication | 4 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit | Persistence | 1 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit | Presumed persistence | 0 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit | Missing data | 0 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit | Indeterminate | 2 Participants |
| Complicated Urinary Tract Infection (cUTI) | Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit | Eradication | 3 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit | Indeterminate | 9 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit | Missing data | 5 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit | Presumed eradication | 18 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit | Presumed persistence | 3 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit | Eradication | 7 Participants |
| Complicated Intra-abdominal Infection (cIAI) | Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit | Persistence | 0 Participants |