Complicated Urinary Tract Infection, Acute Pyelonephritis
Conditions
Keywords
Complicated Urinary Tract Infection, Acute Pyelonephritis
Brief summary
The key purpose of this study is to evaluate the efficacy, safety and pharmacokinetics (PK) of tebipenem pivoxil hydrobromide (TBPM-PI-HBr) compared to intravenous (IV) ertapenem, in participants with complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP).
Interventions
DRUGErtapenem
Antibiotic Therapy for cUTI.
DRUGDummy Infusion
Dummy intravenous infusion.
DRUGTBPM-PI-HBr
TBPM-PI-HBr tablets administered orally.
DRUGDummy tablets
Dummy tablets orally.
Sponsors
Spero Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male and female participants at least 18 years of age. 2. Able to provide informed consent. 3. Able to ingest oral tablets for the anticipated treatment duration. If present at baseline, nausea and/or vomiting should have been mild or well-controlled with antiemetic therapy, in order to tolerate oral study drug. 4. Have a diagnosis of cUTI or AP as defined below: a. cUTI definition: At least Two of the following signs and symptoms: i. Chills, rigors, or fever; fever must be observed and documented by a health care provider (oral, tympanic, rectal or core temperature \>38.0°C \[\>100.4°F\]) ii. Dysuria, urgency to void, or increased urinary frequency iii. Nausea or vomiting, as reported by the participants iv. Lower abdominal, suprapubic, or pelvic pain And at least One of the following risk factors for cUTI: i. Implanted urinary tract instrumentation (e.g., nephrostomy tube, ureteric stents, or other urinary tract prosthetic material), ongoing intermittent bladder catheterization, or presence of an indwelling bladder catheter (Note: bladder catheters that have been in place for \>24 hours prior to Screening must be removed or replaced prior to collection of the Screening urine for urinalysis and culture, unless removal or replacement is considered unsafe or contraindicated). ii. Current known functional or anatomical abnormality of the urogenital tract, including anatomic abnormalities of the urinary tract, neurogenic bladder, or post-void residual urine volume of ≥ 100 mL within the past 6 months. iii. Complete or partial obstructive uropathy (e.g., nephrolithiasis, tumor, fibrosis, urethral stricture) that is expected to be medically or surgically treated during study drug therapy (prior to end of the treatment \[EOT\]). iv. Known intrinsic renal disease with blood urea nitrogen (BUN) \>20 mg/deciliter (dL), or blood urea \>42.8 mg/dL, or serum creatinine (Cr) \>1.4 mg/dL. v. Urinary retention, including urinary retention in men due to previously diagnosed benign prostatic hyperplasia (BPH). b. AP definition: Acute flank pain (onset within 7 days prior to randomization) or costovertebral angle tenderness on physical examination. And at least One of the following signs and symptoms: i. Chills, rigors, or fever; fever must be observed and documented by a health care provider (oral, tympanic, rectal or core temperature \>38.0°C \[\>100.4°F\]). ii. Peripheral white blood cell count (WBC) \>10,000/mm3 or bandemia (≥15% immature polymorphonuclear neutrophils (PMNs), regardless of WBC count). iii. Nausea or vomiting, as reported by the participants. iv. Dysuria, urgency to void, or increased urinary frequency. Note: Participants who meet the definition for cUTI (Inclusion Criterion 4a) and also have flank pain or costovertebral tenderness should be randomized as cUTI rather than AP. 5. Have an adequate urine specimen for evaluation and culture obtained within 24 h prior to randomization with evidence of pyuria that includes at least one of the following: 1. At least 10 WBCs per high power field (hpf) in urine sediment. 2. At least 10 WBCs per cubic millimeter (mm3) in unspun (non-centrifuged) urine. 3. Positive leukocyte esterase (LE) on urinalysis. Note: Participants could be randomized and administered investigational product (IP) prior to knowledge of urine culture results. 6. Expectation, in the judgment of the Investigator, that the participant would survive with effective antibiotic therapy and appropriate supportive care for the anticipated duration of the study. 7. Willing to comply with all the study activities and procedures throughout the duration of the study. 8. Participants were required to use a highly-effective method of birth control; male participants were required to use an effective barrier method of contraception from Screening through LFU and for 90 days following the last dose if sexually active with a female of childbearing potential (FOCP); female participants must not have been pregnant or nursing, and were required to commit to either sexual abstinence or use at least two medically accepted, effective methods of birth control (e.g., condom, spermicidal gel, oral contraceptive, indwelling intrauterine device, hormonal implant/patch, injections, approved cervical ring) from Screening through LFU and for 90 days following the last dose.
Exclusion criteria
1. Presence of any known or suspected disease or condition that, in the opinion of the Investigator, may have confounded the assessment of efficacy, including but not limited to the following: 1. Perinephric or renal corticomedullary abscess. 2. Uncomplicated urinary tract infection (cUTI) - (acute cystitis that does not meet the cUTI disease definition, see Inclusion Criterion 4a). 3. Polycystic kidney disease. 4. Recent history of trauma to the pelvis or urinary tract. 5. Confirmed or suspected acute or chronic bacterial prostatitis, orchitis, or epididymitis. 6. Chronic vesicoureteral reflux. 7. Previous or planned renal transplantation. 8. Previous or planned cystectomy or ileal loop surgery. 9. Known or suspected non-renal source of infection (e.g., infective endocarditis, osteomyelitis, meningitis, pneumonia). 10. Confirmed or suspected infection that is caused by a pathogen that is resistant to either IP (e.g., carbapenem-resistant pathogen), including infection caused by fungi (e.g., candiduria) or mycobacteria (e.g., urogenital tuberculosis). 2. Gross hematuria requiring intervention other than administration of IP or removal/placement of urinary tract instrumentation. 3. Urinary tract surgery within 7 days prior to randomization or urinary tract surgery planned during the study period (except surgery required relieving an obstruction or placing urinary tract instrumentation). 4. Creatinine clearance (CrCl) of ≤30 mL/min, as estimated by the Cockcroft-Gault formula: estimated Creatinine Clearance (eC\_Cr) \[mL/min\]=((140-Age \[yrs\]) × Body Weight \[kg\] × \[0.85 if Female\])/(72 × Serum Creatinine \[mg⁄dL\]). 5. Anticipated concomitant use of non-study antibacterial drug therapy between randomization and the LFU Visit that would potentially effect outcome evaluations of cUTI/ AP, including but not limited to antibacterials with potential activity versus uropathogens, antibacterial drug prophylaxis, and antibacterial bladder irrigation. 6. Anticipated concomitant use of gastric acid-reducing medications between randomization and end-of-treatment (EOT), including proton pump inhibitors, histamine-2 receptor antagonists, and antacids. 7. Receipt of more than a single dose of a short-acting potentially effective antibiotic started within 72 h prior to randomization. Exception: Participants who received more than a single dose of short-acting potentially effective antibiotic within 72 h prior to randomization may be eligible for enrollment if they meet all of the following criteria: 1. In the opinion of the Investigator they have failed the prior antibiotic therapy (e.g., have worsening signs and symptoms of cUTI/AP). 2. Had a documented uropathogen (growth in urine culture \>10\^5 CFU/mL) that is resistant to the prior antibiotic therapy. 3. Had a documented uropathogen that is carbapenem-susceptible. 4. Received approval from the Medical Monitor to enroll the participants. 8. Severe hepatic impairment at Screening, as evidenced by alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>5x upper limit of normal (ULN) or total bilirubin \>3x ULN, or clinical signs of cirrhosis or end-stage hepatic disease (e.g., ascites, hepatic encephalopathy). 9. Any signs of severe sepsis, including shock or profound hypotension defined as systolic blood pressure \<90 mmHg or a decrease of \>40 mmHg from baseline that is not responsive to fluid challenge. 10. Pregnant or breastfeeding women. 11. History of epilepsy or known seizure disorder (excluding a history of childhood febrile seizures). 12. Receipt of any investigational medication during the last 30 days or 5 half-lives, whichever is longer, prior to randomization. 13. Known history of human immunodeficiency virus (HIV) infection and or acquired immunodeficiency syndrome (AIDS)-defining illness, or known history of HIV infection and known CD4 count \<200/mm\^3 within the past year. 14. Presence of immunodeficiency or an immunocompromised condition including neutropenia (\<1,000 neutrophils/mm\^3 obtained from the local laboratory at Screening), hematologic malignancy, bone marrow transplant, or receiving immunosuppressive therapy such as cancer chemotherapy, medications for the rejection of transplantation, and long-term use of systemic corticosteroids (e.g., ≥20 mg/day of prednisone or systemic equivalent for at least 2 weeks). 15. A mean QT interval corrected using Fridericia's formula (QTcF) \>480 msec based on triplicate ECGs at Screening. 16. History of significant hypersensitivity or allergic reaction to β-lactam antibiotics (e.g., cephalosporins, penicillins, carbapenems), product excipients (mannitol, microcrystalline cellulose, crospovidone, magnesium stearate, colloidal silicon dioxide, and Opadry®) or any contraindication to the use of ertapenem. 17. History of known genetic metabolism anomaly associated with carnitine deficiency (e.g., carnitine transporter defect, methylmalonic aciduria, propionic acidemia) 18. Requirement for concomitant use of valproic acid, divalproex sodium, or probenecid between randomization and EOT. 19. Unable or unwilling to comply with the protocol. 20. An employee of the Investigator or study center with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as a family member of the employee or the Investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response (Combined Clinical Cure and Microbiological Eradication) at Test-of-Cure (TOC) in Micro Intent-to-Treat Population | Day 19 (TOC) | Overall response is participants with combined clinical cure and microbiological eradication. Clinical cure is defined as complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \<10\^3 colony forming unit/milliliter (CFU/mL) and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) in The Safety Population | From the first dose of administration up to Day 25 post-treatment ± 2 days (up to approximately 27 days) | An Adverse Event (AE) was defined as any untoward medical occurrence in a subject or clinical investigation participant administered a pharmaceutical product, which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational/experimental) product, whether or not related to this product. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Cure at EOT Days the Clinically Evaluable (CE-EOT) Populations | Day 15 (EOT) | Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. |
| Clinical Cure at TOC in the CE-TOC Populations | Day 19 (TOC) | Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. |
| Sustained Clinical Cure at LFU in the CE-LFU Populations | Day 25 (LFU) | Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Sustained clinical cure is defined as number of participants who met criteria for clinical cure at TOC and remained free of signs and symptoms of cUTI or AP at LFU. |
| Clinical Cure at EOT in the ME-EOT Populations | Day 15 (EOT) | Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. |
| Clinical Cure at TOC Days in the ME-TOC Populations | Day 19 (TOC) | Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. |
| Sustained Clinical Cure at LFU in the ME-LFU Population | Day 25 (LFU) | Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Sustained clinical cure is defined as participants who met criteria for clinical cure at TOC and remained free of signs and symptoms of cUTI or AP at LFU. |
| By-Patient Microbiological Eradication at EOT, TOC, and Sustained Microbiological Eradication at LFU Days in the Micro-ITT Population | Days 15 (EOT), 19 (TOC) and 25 (LFU) | Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Microbiological eradication is defined as number of participants with reduction of Baseline urine pathogen(s) to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at Baseline. Sustained Microbiological Eradication is defined as number of participants with microbiologic eradication at the TOC and no subsequent urine culture after TOC demonstrating recurrence of the original baseline uropathogen at ≥10\^5 CFU/mL. |
| By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Days 15 (EOT) | Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Microbiological eradication rate is the percentage of pathogens being eradicated from the overall number of pathogens analyzed. |
| By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Day 19 (TOC) | Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Microbiological eradication rate is the percentage of pathogens being eradicated from the overall number of pathogens analyzed. |
| By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Day 25 (LFU) | Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Sustained Microbiological Eradication is defined as microbiologic eradication at the TOC and no subsequent urine culture after TOC demonstrating recurrence of the original baseline uropathogen at ≥10\^5 CFU/mL. Microbiological eradication rate is the percentage of pathogens being eradicated from the overall number of pathogen analyzed. |
| By-Patient Microbiological Eradication at EOT in the ME-EOT Populations | Day 15 (EOT) | Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. |
| By-Patient Microbiological Eradication at TOC in the ME-TOC Population | Day 15 (TOC) | Microbiological eradication is defined as number of participants with reduction of baseline urine pathogen(s) to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Microbiological eradication rate is the percentage of pathogens being eradicated from the overall number of pathogens analyzed. |
| By-Patient Sustained Microbiological Eradication at LFU Days in the ME-LFU Populations | Day 25 (LFU) | Microbiological eradication is defined as number of participants with reduction of baseline urine pathogen(s) to \<10\^3 colony forming unit/milliliter (CFU/mL) and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Sustained Microbiological Eradication is defined participants with microbiologic eradication at the TOC and no subsequent urine culture after TOC demonstrating recurrence of the original baseline uropathogen at ≥10\^5 CFU/mL. |
| By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Day 15 (EOT) | Microbiological eradication is defined as number of participants with reduction of baseline urine pathogen(s) to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Microbiological eradication rate is the percentage of pathogens being eradicated from the overall number of pathogens analyzed. |
| Overall Response (Combined Clinical Cure Plus Microbiological Eradication) At Test-Of-Cure (TOC) In The Microbiologically Evaluable (ME) - TOC Population | Day 19 (TOC) | Overall response is participants with combined clinical cure and microbiological eradication. Clinical cure is defined as complete resolution or significant improvement of signs and symptoms of cUTI or acute pyelonephritis (AP) that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. |
| By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | Day 25 (LFU) | Microbiological eradication is defined as number of participants with reduction of baseline urine pathogen(s) to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Sustained Microbiological Eradication is defined participants with microbiologic eradication at the TOC and no subsequent urine culture after TOC demonstrating recurrence of the original baseline uropathogen at ≥10\^5 CFU/mL.Microbiological eradication rate is the percentage of pathogens being eradicated from the overall number of pathogen analyzed. |
| Overall Response Rate (Combined Clinical Cure Plus Microbiological Eradication) In Subgroup Including: Stratified Infection Category | Day 19 (TOC) | Overall response rate is percentage of participants with combined clinical cure plus microbiological eradication. Clinical cure is defined as complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \<10\^3 colony forming unit/milliliter (CFU/mL) and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. |
| Overall Response Rate (Combined Clinical Cure Plus Microbiological Eradication) at TOC In Subgroup Stratified Age Category | Day 19 (TOC) | Overall response rate is percentage of participants with combined clinical cure plus microbiological eradication. Clinical cure is defined as complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. |
| Overall Response Rate (Combined Clinical Cure Plus Microbiological Eradication) at TOC In Subgroup Including Region | Day 25 (LFU) | Overall response rate is percentage of participants with combined clinical cure plus microbiological eradication. Clinical cure is defined as complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \<10\^3 colony forming unit/milliliter (CFU/mL) and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. The point estimate and confidence interval (CI) is presented for Central and eastern Europe subgroup. |
| Time (Days) to Resolution or Improvement of Signs and Symptoms of cUTI and AP Present a Baseline in the Micro-ITT Populations | Day 25 (LFU) | Time (days) to resolution or improvement of signs and symptoms of cUTI and AP present at baseline was defined as follows: date of the first visit at which all baseline signs/symptoms have improved by at least 1 grade with worsening of none and development of no new signs/symptoms of the index infection minus the date of randomization. |
| Time (Days) to Defervescence in Micro-ITT Population With a Documented Fever at Screening or Day 1 | Day 25 (LFU) | Time to Defervescence (days) = date of first post-baseline temperature measure with maximum daily Temperature ≤38°C at the date of randomization. |
| Rate of Clinical Relapse at the LFU Days in the Micro-ITT Population | Day 25 (LFU) | Clinical relapse is participants who met criteria for clinical cure at TOC, but new signs and symptoms of cUTI or AP are present at the LFU Visit and the subject requires antibiotic therapy for the cUT. Clinical cure is defined as complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. |
| Rates Of Superinfection And New Infection In The Micro-ITT Population | Day 25 (LFU) | Superinfection was isolation of a new uropathogen at ≥105 CFU/mL (other than the original Baseline pathogen\[s\] from blood and/or urine) from a urine culture that was accompanied by clinical signs and symptoms of infection requiring alternative antimicrobial therapy (e.g., the participant was assessed by the investigator as a clinical failure) during the period up to and including EOT. New infection was isolation of a new uropathogen at ≥105 CFU/mL (other than the original baseline pathogen\[s\] from blood and/or urine) from a urine culture that was accompanied by clinical signs and symptoms of infection requiring alternative antimicrobial therapy (e.g., the participant was assessed by the Investigator as a clinical failure) in the period after EOT. |
| Apparent Volume of Distribution (Vss) at Steady State in TBPM-PI-HBr Recipients in the Pharmacokinetic (PK) Population | Predose and post-dose at 0.25h, 0.5h, 1h, 2h, and 8h on Days 1 and 3 | — |
| Cmax in TBPM-PI-HBr Recipients in the PK Population | Predose and post-dose at 0.25h, 0.5h, 1h, 2h, and 8h on Days 1 and 3 | — |
| Area Under Curve (AUC 0-24) in TBPM-PI-HBr Recipients in the PK Population | Predose and post-dose at 0.25h, 0.5h, 1h, 2h, and 8h on Days 1 and 3 | — |
| Minimum Concentration (Cmin) in TBPM-PI-HBr Recipients in the PK Population | Predose and post-dose at 0.25h, 0.5h, 1h, 2h, and 8h on Days 1 and 3 | — |
| Systemic Clearance (CL) in TBPM-PI-HBr Recipients in the PK Population | Predose and post-dose at 0.25h, 0.5h, 1h, 2h, and 8h on Days 1 and 3 | — |
| By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Day 19 (TOC) | Microbiological eradication is defined as number of participants with reduction of baseline urine pathogen(s) to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Microbiological eradication rate is the percentage of pathogens being eradicated from the overall number of participants analyzed. |
| Clinical Cure at End-of-Treatment (EOT), TOC, and Sustained Clinical Cure at Late Follow-Up (LFU) Days in the Micro-ITT Populations | Days 15 (EOT), Day 19 (TOC) and Day 25 (LFU) | Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Sustained clinical cure is defined as participants who met criteria for clinical cure at TOC and remained free of signs and symptoms of cUTI or AP at LFU. |
Countries
Bulgaria, Czechia, Estonia, Georgia, Hungary, Latvia, Moldova, Poland, Romania, Russia, Serbia, Slovakia, South Africa, Ukraine, United States
Participant flow
Recruitment details
Participants took part in the study at 95 study centers in Bulgaria, Czech Republic, Estonia, Georgia, Hungary, Latvia, Moldova, Poland, Romania, Russia, Serbia, Slovakia, South Africa, Ukraine, and the United States from 03 June 2019 to 27 May 2020.
Pre-assignment details
Participants with diagnosis of complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) were enrolled to receive tebipenem pivoxil hydrobromide (TBPM-PI-HBr) and ertapenem.
Participants by arm
| Arm | Count |
|---|---|
| TBPM-PI-HBr 600 mg TBPM-PI-HBr 600 mg (300 mg×2 ) film-coated tablets, administered orally three times per day (every 8 hours \[q8h\] ± 0.5 h) plus a single dummy IV infusion over 30 minutes (min) once daily (every 24 hours \[q24h\] ± 0.5 h) up to Day 15; participants with moderate renal insufficiency (creatinine clearance \[CrCl\] \>30 to ≤50 mL/min) required TBPM-PI-HBr dosage adjustment to 300 mg (one tablet) q8h ± 0.5 h. | 685 |
| Ertapenem 1 g Ertapenem for IV injection, administered as a 1-gram IV infusion over 30 min once daily (q24h ± 0.5 h) plus dummy placebo tablets administered orally q8h (±0.5 h) up to Day 14; no dose adjustment of ertapenem was required for participants with renal insufficiency. | 687 |
| Total | 1,372 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | COVID-19 | 1 | 2 |
| Overall Study | Lost to Follow-up | 14 | 10 |
| Overall Study | Participant Non-Compliance/Uncooperativeness | 3 | 6 |
| Overall Study | Participant Withdrawal of Consent | 13 | 5 |
Baseline characteristics
| Characteristic | Ertapenem 1 g | Total | TBPM-PI-HBr 600 mg |
|---|---|---|---|
| Age, Continuous | 57.2 years STANDARD_DEVIATION 18.23 | 56.9 years STANDARD_DEVIATION 18.45 | 56.7 years STANDARD_DEVIATION 18.68 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 18 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 682 Participants | 1354 Participants | 672 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 12 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 677 Participants | 1353 Participants | 676 Participants |
| Sex: Female, Male Female | 389 Participants | 757 Participants | 368 Participants |
| Sex: Female, Male Male | 298 Participants | 615 Participants | 317 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 685 | 0 / 687 |
| other Total, other adverse events | 39 / 685 | 30 / 687 |
| serious Total, serious adverse events | 14 / 685 | 12 / 687 |
Outcome results
Primary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) in The Safety Population
An Adverse Event (AE) was defined as any untoward medical occurrence in a subject or clinical investigation participant administered a pharmaceutical product, which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational/experimental) product, whether or not related to this product.
Time frame: From the first dose of administration up to Day 25 post-treatment ± 2 days (up to approximately 27 days)
Population: Safety analysis population included all randomized participants who received any amount of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TBPM-PI-HBr 600 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in The Safety Population | 176 Participants |
| Ertapenem 1 g | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in The Safety Population | 176 Participants |
Primary
Overall Response (Combined Clinical Cure and Microbiological Eradication) at Test-of-Cure (TOC) in Micro Intent-to-Treat Population
Overall response is participants with combined clinical cure and microbiological eradication. Clinical cure is defined as complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \<10\^3 colony forming unit/milliliter (CFU/mL) and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline.
Time frame: Day 19 (TOC)
Population: Microbiological intent-to-treat population (Micro-ITT) included all randomized participants with a confirmed diagnosis of cUTI or AP and a positive Screening urine culture defined as growth of one or two uropathogens at ≥10\^5 CFU/mL and/or positive Screening blood culture with isolation of one or more uropathogens.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TBPM-PI-HBr 600 mg | Overall Response (Combined Clinical Cure and Microbiological Eradication) at Test-of-Cure (TOC) in Micro Intent-to-Treat Population | 264 Participants |
| Ertapenem 1 g | Overall Response (Combined Clinical Cure and Microbiological Eradication) at Test-of-Cure (TOC) in Micro Intent-to-Treat Population | 258 Participants |
95% CI: [-9.7, 3.2]
Secondary
Apparent Volume of Distribution (Vss) at Steady State in TBPM-PI-HBr Recipients in the Pharmacokinetic (PK) Population
Time frame: Predose and post-dose at 0.25h, 0.5h, 1h, 2h, and 8h on Days 1 and 3
Population: PK population included participants treated with at least 1 dose of TBPM-PI-HBr with at least 1 analyzable plasma or urine PK sample. The data is reported only for TBPM-PI-HBr arm.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| TBPM-PI-HBr 600 mg | Apparent Volume of Distribution (Vss) at Steady State in TBPM-PI-HBr Recipients in the Pharmacokinetic (PK) Population | Day 1 | 75.5 Liters (L) |
| TBPM-PI-HBr 600 mg | Apparent Volume of Distribution (Vss) at Steady State in TBPM-PI-HBr Recipients in the Pharmacokinetic (PK) Population | Day 3 | 75.5 Liters (L) |
Secondary
Area Under Curve (AUC 0-24) in TBPM-PI-HBr Recipients in the PK Population
Time frame: Predose and post-dose at 0.25h, 0.5h, 1h, 2h, and 8h on Days 1 and 3
Population: PK population included participants treated with at least 1 dose of TBPM-PI-HBr with at least 1 analyzable plasma or urine PK sample. The data is reported only for TBPM-PI-HBr arm.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| TBPM-PI-HBr 600 mg | Area Under Curve (AUC 0-24) in TBPM-PI-HBr Recipients in the PK Population | Day 1 | 65.5 microgram.hour per milliliter (μg•h/mL) |
| TBPM-PI-HBr 600 mg | Area Under Curve (AUC 0-24) in TBPM-PI-HBr Recipients in the PK Population | Day 3 | 74.6 microgram.hour per milliliter (μg•h/mL) |
Secondary
By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population
Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Microbiological eradication rate is the percentage of pathogens being eradicated from the overall number of pathogens analyzed.
Time frame: Days 15 (EOT)
Population: Micro-ITT-all randomized participants with confirmed diagnosis of cUTI/AP and positive Screening urine culture defined as growth of one or two uropathogens at ≥10\^5 CFU/mL and/or positive Screening blood culture with isolation of one or more uropathogens. Overall Number of Units Analyzed=number of pathogens available for analysis at given timepoint. Participant may have had more than 1 pathogen. Multiple isolates of same species/category from same participant are counted only once towards total.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TBPM-PI-HBr 600 mg | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Enterobacterales, Klebsiella oxytoca | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Enterobacterales, Citrobacter freundii | 75.0 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Enterobacterales, Providencia rettgeri | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Enterobacterales, Klebsiella pneumoniae | 98.1 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Enterobacterales, Providencia stuartii | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Enterobacterales, Escherichia coli | 98.3 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Enterobacterales, Raoultella ornithinolytica | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Enterobacterales, Klebsiella variicola | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Enterobacterales, Serratia marcescens | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Enterobacterales, Citrobacter koseri | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Gram Positive, Enterococcus faecalis | 94.8 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Enterobacterales, Morganella morganii | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Gram Positive, Enterococcus faecium | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Enterobacterales, Klebsiella aerogenes | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Gram Positive, Enterococcus hirae | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Gram Positive, Staphylococcus aureus | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Enterobacterales, Proteus hauseri | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Gram Positive, Staphylococcus lugdunensis | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Enterobacterales, Proteus mirabilis | 97.1 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Gram Positive, Staphylococcus saprophyticus | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Enterobacterales, Enterobacter cloacae | 90.9 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Gram Positive, Streptococcus gallolyticus | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Enterobacterales, Citrobacter braakii | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Gram Positive, Staphylococcus lugdunensis | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Gram Positive, Staphylococcus saprophyticus | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Gram Positive, Staphylococcus aureus | 75.0 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Enterobacterales, Citrobacter freundii | 66.7 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Enterobacterales, Citrobacter koseri | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Enterobacterales, Enterobacter amnigenus | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Enterobacterales, Enterobacter asburiae | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Enterobacterales, Enterobacter bugandensis | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Enterobacterales, Enterobacter cloacae | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Enterobacterales, Escherichia coli | 96.7 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Enterobacterales, Klebsiella aerogenes | 0.0 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Enterobacterales, Klebsiella oxytoca | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Enterobacterales, Klebsiella pneumoniae | 98.6 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Enterobacterales, Klebsiella variicola | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Enterobacterales, Morganella morganii | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Enterobacterales, Proteus mirabilis | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Enterobacterales, Proteus penneri | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Enterobacterales, Proteus vulgaris | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Enterobacterales, Providencia rettgeri | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Enterobacterales, Providencia stuartii | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Enterobacterales, Serratia liquefaciens | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Enterobacterales, Serratia marcescens | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Gram Positive, Enterococcus faecalis | 91.7 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Gram Positive, Enterococcus faecium | 100 percentage of pathogen eradication |
Secondary
By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population
Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Microbiological eradication rate is the percentage of pathogens being eradicated from the overall number of pathogens analyzed.
Time frame: Day 19 (TOC)
Population: Micro-ITT included all randomized participants with a confirmed diagnosis of cUTI or AP and a positive Screening urine culture defined as growth of one or two uropathogens at ≥10\^5 CFU/mL and/or positive Screening blood culture with isolation of one or more uropathogens. Number analyzed are the number of pathogens available for analysis at the given timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TBPM-PI-HBr 600 mg | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Enterobacterales, Klebsiella oxytoca | 75.0 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Enterobacterales, Citrobacter freundii | 50.0 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Enterobacterales, Providencia rettgeri | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Enterobacterales, Klebsiella pneumoniae | 45.3 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Enterobacterales, Providencia stuartii | 0.0 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Enterobacterales, Escherichia coli | 62.7 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Enterobacterales, Raoultella ornithinolytica | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Enterobacterales, Klebsiella variicola | 50.0 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Enterobacterales, Serratia marcescens | 50.0 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Enterobacterales, Citrobacter koseri | 66.7 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Gram Positive, Enterococcus faecalis | 67.2 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Enterobacterales, Morganella morganii | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Gram Positive, Enterococcus faecium | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Enterobacterales, Klebsiella aerogenes | 0.0 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Gram Positive, Enterococcus hirae | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Gram Positive, Staphylococcus aureus | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Enterobacterales, Proteus hauseri | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Gram Positive, Staphylococcus lugdunensis | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Enterobacterales, Proteus mirabilis | 48.6 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Gram Positive, Staphylococcus saprophyticus | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Enterobacterales, Enterobacter cloacae | 54.5 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Gram Positive, Streptococcus gallolyticus | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Enterobacterales, Citrobacter braakii | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Gram Positive, Staphylococcus lugdunensis | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Gram Positive, Staphylococcus saprophyticus | 83.3 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Gram Positive, Staphylococcus aureus | 37.5 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Enterobacterales, Citrobacter freundii | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Enterobacterales, Citrobacter koseri | 50.0 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Enterobacterales, Enterobacter amnigenus | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Enterobacterales, Enterobacter asburiae | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Enterobacterales, Enterobacter bugandensis | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Enterobacterales, Enterobacter cloacae | 50.0 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Enterobacterales, Escherichia coli | 65.2 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Enterobacterales, Klebsiella aerogenes | 0.0 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Enterobacterales, Klebsiella oxytoca | 33.3 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Enterobacterales, Klebsiella pneumoniae | 63.4 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Enterobacterales, Klebsiella variicola | 75.0 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Enterobacterales, Morganella morganii | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Enterobacterales, Proteus mirabilis | 69.6 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Enterobacterales, Proteus penneri | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Enterobacterales, Proteus vulgaris | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Enterobacterales, Providencia rettgeri | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Enterobacterales, Providencia stuartii | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Enterobacterales, Serratia liquefaciens | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Enterobacterales, Serratia marcescens | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Gram Positive, Enterococcus faecalis | 55.6 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Gram Positive, Enterococcus faecium | 100 percentage of pathogen eradication |
Secondary
By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations
Microbiological eradication is defined as number of participants with reduction of baseline urine pathogen(s) to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Microbiological eradication rate is the percentage of pathogens being eradicated from the overall number of pathogens analyzed.
Time frame: Day 15 (EOT)
Population: ME-EOT population included participants who met the definitions of both the micro-ITT Population and CE Population and were defined for each visit for the analyses in the ME Population at each respective visit as outlined in the ERP. Number analyzed are the number of pathogens available for analysis at the given timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TBPM-PI-HBr 600 mg | By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Enterobacterales, Klebsiella oxytoca | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Enterobacterales, Enterobacter cloacae | 90.9 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Enterobacterales, Providencia rettgeri | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Enterobacterales, Klebsiella pneumoniae | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Enterobacterales, Providencia stuartii | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Enterobacterales, Citrobacter freundii | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Enterobacterales, Raoultella ornithinolytica | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Enterobacterales, Klebsiella variicola | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Enterobacterales, Serratia marcescens | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Enterobacterales, Escherichia coli | 99.6 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Gram Positive, Enterococcus faecalis | 98.1 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Enterobacterales, Morganella morganii | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Gram Positive, Enterococcus faecium | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Enterobacterales, Citrobacter koseri | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Gram Positive, Enterococcus hirae | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Gram Positive, Staphylococcus aureus | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Enterobacterales, Proteus hauseri | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Gram Positive, Staphylococcus lugdunensis | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Enterobacterales, Proteus mirabilis | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Gram Positive,Staphylococcus saprophyticus | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Enterobacterales, Klebsiella aerogenes | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Gram Positive, Streptococcus gallolyticus | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Gram Positive, Staphylococcus lugdunensis | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Gram Positive,Staphylococcus saprophyticus | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Gram Positive, Staphylococcus aureus | 85.7 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Enterobacterales, Citrobacter freundii | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Enterobacterales, Citrobacter koseri | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Enterobacterales, Enterobacter amnigenus | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Enterobacterales, Enterobacter asburiae | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Enterobacterales, Enterobacter bugandensis | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Enterobacterales, Enterobacter cloacae | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Enterobacterales, Escherichia coli | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Enterobacterales, Klebsiella oxytoca | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Enterobacterales, Klebsiella pneumoniae | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Enterobacterales, Klebsiella variicola | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Enterobacterales, Morganella morganii | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Enterobacterales, Proteus mirabilis | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Enterobacterales, Proteus penneri | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Enterobacterales, Proteus vulgaris | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Enterobacterales, Providencia rettgeri | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Enterobacterales, Providencia stuartii | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Enterobacterales, Serratia liquefaciens | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Enterobacterales, Serratia marcescens | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Gram Positive, Enterococcus faecalis | 97.1 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Gram Positive, Enterococcus faecium | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Enterobacterales, Citrobacter braakii | 100 percentage of pathogen eradication |
Secondary
By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations
Microbiological eradication is defined as number of participants with reduction of baseline urine pathogen(s) to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Microbiological eradication rate is the percentage of pathogens being eradicated from the overall number of participants analyzed.
Time frame: Day 19 (TOC)
Population: ME-EOT population included participants who met the definitions of both the micro-ITT Population and CE Population and were defined for each visit for the analyses in the ME Population at each respective visit as outlined in the ERP. Number analyzed are the number of pathogens available for analysis at the given timepoint. A participant may have had more than 1 pathogen. Multiple isolates of the same species/category from the same participants are counted only once towards total.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TBPM-PI-HBr 600 mg | By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Gram Positive, Enterococcus faecalis | 69.8 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Enterobacterales, Citrobacter freundii | 66.7 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Enterobacterales, Citrobacter koseri | 66.7 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Enterobacterales, Enterobacter cloacae | 54.5 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Enterobacterales, Escherichia coli | 65.8 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Enterobacterales, Klebsiella aerogenes | 0.0 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Enterobacterales, Klebsiella oxytoca | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Enterobacterales, Klebsiella pneumoniae | 49.0 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Enterobacterales, Klebsiella variicola | 50.0 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Enterobacterales, Morganella morganii | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Enterobacterales, Proteus hauseri | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Enterobacterales, Proteus mirabilis | 51.6 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Enterobacterales, Providencia rettgeri | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Enterobacterales, Providencia stuartii | 0.0 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Enterobacterales, Raoultella ornithinolytica | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Enterobacterales, Serratia marcescens | 66.7 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Gram Positive, Streptococcus gallolyticus | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Gram Positive, Enterococcus faecium | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Gram Positive, Enterococcus hirae | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Gram Positive, Staphylococcus aureus | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Gram Positive, Staphylococcus lugdunensis | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Gram Positive,Staphylococcus saprophyticus | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Enterobacterales, Serratia marcescens | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Gram Positive, Staphylococcus lugdunensis | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Enterobacterales, Proteus mirabilis | 76.2 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Enterobacterales, Citrobacter braakii | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Enterobacterales, Proteus penneri | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Enterobacterales, Citrobacter freundii | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Enterobacterales, Proteus vulgaris | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Enterobacterales, Citrobacter koseri | 66.7 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Enterobacterales, Enterobacter amnigenus | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Enterobacterales, Enterobacter asburiae | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Enterobacterales, Enterobacter bugandensis | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Gram Positive, Enterococcus faecalis | 57.6 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Enterobacterales, Enterobacter cloacae | 50.0 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Enterobacterales, Providencia rettgeri | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Enterobacterales, Escherichia coli | 68.3 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Gram Positive, Staphylococcus aureus | 50.0 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Enterobacterales, Providencia stuartii | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Enterobacterales, Klebsiella oxytoca | 50.0 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Gram Positive, Enterococcus faecium | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Enterobacterales, Klebsiella pneumoniae | 71.0 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Enterobacterales, Serratia liquefaciens | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Enterobacterales, Klebsiella variicola | 75.0 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Gram Positive,Staphylococcus saprophyticus | 83.3 percentage of pathogen eradication |
| Ertapenem 1 g | By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Enterobacterales, Morganella morganii | 100 percentage of pathogen eradication |
Secondary
By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT)
Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Sustained Microbiological Eradication is defined as microbiologic eradication at the TOC and no subsequent urine culture after TOC demonstrating recurrence of the original baseline uropathogen at ≥10\^5 CFU/mL. Microbiological eradication rate is the percentage of pathogens being eradicated from the overall number of pathogen analyzed.
Time frame: Day 25 (LFU)
Population: mITT-all randomized participants with confirmed diagnosis of cUTI/AP \& positive Screening urine culture defined as growth of one/two uropathogens at ≥10\^5 CFU/mL and/or positive Screening blood culture with isolation of one or more uropathogens. Overall Number of Units Analyzed are number of enterobacterale pathogens. Participant may have more than 1 pathogen. Multiple isolates of same species/category from same participants are counted once towards total.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TBPM-PI-HBr 600 mg | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Raoultella ornithinolytica | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Citrobacter freundii | 50.0 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Citrobacter koseri | 66.7 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Enterobacter cloacae | 54.5 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Enterococcus faecalis | 63.8 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Enterococcus faecium | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Enterococcus hirae | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Escherichia coli | 59.9 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Klebsiella aerogenes | 0.0 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Klebsiella oxytoca | 75.0 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Klebsiella pneumoniae | 43.4 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Klebsiella variicola | 50.0 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Morganella morganii | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Proteus hauseri | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Proteus mirabilis | 48.6 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Providencia rettgeri | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Providencia stuartii | 0.0 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Serratia marcescens | 50.0 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Staphylococcus aureus | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Staphylococcus lugdunensis | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Staphylococcus saprophyticus | 100 percentage of pathogen eradication |
| TBPM-PI-HBr 600 mg | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Staphylococcus gallolyticus | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Klebsiella pneumoniae | 60.6 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Citrobacter braakii | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Klebsiella variicola | 75.0 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Serratia liquefaciens | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Morganella morganii | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Citrobacter freundii | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Staphylococcus saprophyticus | 83.3 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Citrobacter koseri | 50.0 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Enterobacter amnigenus | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Enterobacter asburiae | 0 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Enterobacter bugandensis | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Serratia marcescens | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Enterobacter cloacae | 37.5 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Proteus mirabilis | 60.9 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Enterococcus faecalis | 50.0 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Proteus penneri | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Enterococcus faecium | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Proteus vulgaris | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Staphylococcus lugdunensis | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Escherichia coli | 60.0 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Providencia rettgeri | 100 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Klebsiella aerogenes | 0.0 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Staphylococcus aureus | 37.5 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Klebsiella oxytoca | 33.3 percentage of pathogen eradication |
| Ertapenem 1 g | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Providencia stuartii | 100 percentage of pathogen eradication |
Secondary
By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations
Microbiological eradication is defined as number of participants with reduction of baseline urine pathogen(s) to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Sustained Microbiological Eradication is defined participants with microbiologic eradication at the TOC and no subsequent urine culture after TOC demonstrating recurrence of the original baseline uropathogen at ≥10\^5 CFU/mL.Microbiological eradication rate is the percentage of pathogens being eradicated from the overall number of pathogen analyzed.
Time frame: Day 25 (LFU)
Population: ME-LFU population included participants who met the definitions of both the micro-ITT Population and CE Population and were defined for each visit for the analyses in the ME Population at each respective visit as outlined in the ERP. Overall Number of Units Analyzed are the number of enterobacteral pathogens. A participant may have had more than 1 pathogen. Multiple isolates of the same species/category from the same participants are counted only once towards total.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TBPM-PI-HBr 600 mg | By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | Morganella morganii | 100 percentage of pathogens eradications |
| TBPM-PI-HBr 600 mg | By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | Enterobacter cloacae | 55.6 percentage of pathogens eradications |
| TBPM-PI-HBr 600 mg | By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | Proteus hauseri | 100 percentage of pathogens eradications |
| TBPM-PI-HBr 600 mg | By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | Proteus mirabilis | 51.7 percentage of pathogens eradications |
| TBPM-PI-HBr 600 mg | By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | Enterococcus hirae | 100 percentage of pathogens eradications |
| TBPM-PI-HBr 600 mg | By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | Escherichia coli | 62.4 percentage of pathogens eradications |
| TBPM-PI-HBr 600 mg | By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | Citrobacter freundii | 66.7 percentage of pathogens eradications |
| TBPM-PI-HBr 600 mg | By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | Providencia rettgeri | 100 percentage of pathogens eradications |
| TBPM-PI-HBr 600 mg | By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | Klebsiella aerogenes | 0 percentage of pathogens eradications |
| TBPM-PI-HBr 600 mg | By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | Providencia stuartii | 0.0 percentage of pathogens eradications |
| TBPM-PI-HBr 600 mg | By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | Klebsiella oxytoca | 100 percentage of pathogens eradications |
| TBPM-PI-HBr 600 mg | By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | Raoultella ornithinolytica | 100 percentage of pathogens eradications |
| TBPM-PI-HBr 600 mg | By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | Enterococcus faecalis | 66.7 percentage of pathogens eradications |
| TBPM-PI-HBr 600 mg | By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | Serratia marcescens | 66.7 percentage of pathogens eradications |
| TBPM-PI-HBr 600 mg | By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | Klebsiella pneumoniae | 46.7 percentage of pathogens eradications |
| TBPM-PI-HBr 600 mg | By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | Staphylococcus aureus | 100 percentage of pathogens eradications |
| TBPM-PI-HBr 600 mg | By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | Citrobacter koseri | 100 percentage of pathogens eradications |
| TBPM-PI-HBr 600 mg | By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | 1Staphylococcus lugdunensis | 100 percentage of pathogens eradications |
| TBPM-PI-HBr 600 mg | By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | Klebsiella variicola | 50.0 percentage of pathogens eradications |
| TBPM-PI-HBr 600 mg | By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | Staphylococcus saprophyticus | 100 percentage of pathogens eradications |
| TBPM-PI-HBr 600 mg | By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | Enterococcus faecium | 100 percentage of pathogens eradications |
| TBPM-PI-HBr 600 mg | By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | Staphylococcus gallolyticus | 100 percentage of pathogens eradications |
| Ertapenem 1 g | By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | 1Staphylococcus lugdunensis | 100 percentage of pathogens eradications |
| Ertapenem 1 g | By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | Staphylococcus saprophyticus | 80.0 percentage of pathogens eradications |
| Ertapenem 1 g | By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | Proteus mirabilis | 70.0 percentage of pathogens eradications |
| Ertapenem 1 g | By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | Citrobacter freundii | 100 percentage of pathogens eradications |
| Ertapenem 1 g | By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | Citrobacter koseri | 66.7 percentage of pathogens eradications |
| Ertapenem 1 g | By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | Enterobacter amnigenus | 100 percentage of pathogens eradications |
| Ertapenem 1 g | By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | Enterobacter asburiae | 0 percentage of pathogens eradications |
| Ertapenem 1 g | By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | Enterobacter bugandensis | 100 percentage of pathogens eradications |
| Ertapenem 1 g | By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | Enterobacter cloacae | 33.3 percentage of pathogens eradications |
| Ertapenem 1 g | By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | Enterococcus faecalis | 52.9 percentage of pathogens eradications |
| Ertapenem 1 g | By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | Enterococcus faecium | 100 percentage of pathogens eradications |
| Ertapenem 1 g | By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | Escherichia coli | 61.8 percentage of pathogens eradications |
| Ertapenem 1 g | By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | Klebsiella oxytoca | 50.0 percentage of pathogens eradications |
| Ertapenem 1 g | By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | Klebsiella pneumoniae | 68.4 percentage of pathogens eradications |
| Ertapenem 1 g | By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | Klebsiella variicola | 66.7 percentage of pathogens eradications |
| Ertapenem 1 g | By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | Morganella morganii | 100 percentage of pathogens eradications |
| Ertapenem 1 g | By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | Citrobacter braakii | 100 percentage of pathogens eradications |
| Ertapenem 1 g | By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | Proteus penneri | 100 percentage of pathogens eradications |
| Ertapenem 1 g | By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | Proteus vulgaris | 100 percentage of pathogens eradications |
| Ertapenem 1 g | By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | Providencia rettgeri | 100 percentage of pathogens eradications |
| Ertapenem 1 g | By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | Providencia stuartii | 100 percentage of pathogens eradications |
| Ertapenem 1 g | By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | Serratia liquefaciens | 100 percentage of pathogens eradications |
| Ertapenem 1 g | By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | Serratia marcescens | 100 percentage of pathogens eradications |
| Ertapenem 1 g | By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | Staphylococcus aureus | 50.0 percentage of pathogens eradications |
Secondary
By-Patient Microbiological Eradication at EOT in the ME-EOT Populations
Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline.
Time frame: Day 15 (EOT)
Population: ME-EOT population is a subset which included participants who met the definitions of both the micro-ITT Population and CE Population and were defined for each visit for the analyses in the ME Population at each respective visit as outlined in the ERP.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TBPM-PI-HBr 600 mg | By-Patient Microbiological Eradication at EOT in the ME-EOT Populations | 436 Participants |
| Ertapenem 1 g | By-Patient Microbiological Eradication at EOT in the ME-EOT Populations | 399 Participants |
95% CI: [-1.6, 1.2]
Secondary
By-Patient Microbiological Eradication at EOT, TOC, and Sustained Microbiological Eradication at LFU Days in the Micro-ITT Population
Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Microbiological eradication is defined as number of participants with reduction of Baseline urine pathogen(s) to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at Baseline. Sustained Microbiological Eradication is defined as number of participants with microbiologic eradication at the TOC and no subsequent urine culture after TOC demonstrating recurrence of the original baseline uropathogen at ≥10\^5 CFU/mL.
Time frame: Days 15 (EOT), 19 (TOC) and 25 (LFU)
Population: Micro-ITT include all randomized participants with a confirmed diagnosis of cUTI or AP and a positive Screening urine culture defined as growth of one or two uropathogens at ≥10\^5 CFU/mL and/or positive Screening blood culture with isolation of one or more uropathogens.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TBPM-PI-HBr 600 mg | By-Patient Microbiological Eradication at EOT, TOC, and Sustained Microbiological Eradication at LFU Days in the Micro-ITT Population | EOT | 439 Participants |
| TBPM-PI-HBr 600 mg | By-Patient Microbiological Eradication at EOT, TOC, and Sustained Microbiological Eradication at LFU Days in the Micro-ITT Population | TOC | 267 Participants |
| TBPM-PI-HBr 600 mg | By-Patient Microbiological Eradication at EOT, TOC, and Sustained Microbiological Eradication at LFU Days in the Micro-ITT Population | LFU | 257 Participants |
| Ertapenem 1 g | By-Patient Microbiological Eradication at EOT, TOC, and Sustained Microbiological Eradication at LFU Days in the Micro-ITT Population | EOT | 403 Participants |
| Ertapenem 1 g | By-Patient Microbiological Eradication at EOT, TOC, and Sustained Microbiological Eradication at LFU Days in the Micro-ITT Population | TOC | 266 Participants |
| Ertapenem 1 g | By-Patient Microbiological Eradication at EOT, TOC, and Sustained Microbiological Eradication at LFU Days in the Micro-ITT Population | LFU | 244 Participants |
Comparison: Statistical Analysis 1 (EOT)95% CI: [-0.8, 4.1]
Comparison: Statistical Analysis 2 (TOC)95% CI: [-10.8, 1.9]
95% CI: [-7.9, 5]
Secondary
By-Patient Microbiological Eradication at TOC in the ME-TOC Population
Microbiological eradication is defined as number of participants with reduction of baseline urine pathogen(s) to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Microbiological eradication rate is the percentage of pathogens being eradicated from the overall number of pathogens analyzed.
Time frame: Day 15 (TOC)
Population: ME-TOC population included participants who met the definitions of both the micro-ITT Population and CE Population and were defined for each visit for the analyses in the ME Population at each respective visit as outlined in the ERP.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TBPM-PI-HBr 600 mg | By-Patient Microbiological Eradication at TOC in the ME-TOC Population | 257 Participants |
| Ertapenem 1 g | By-Patient Microbiological Eradication at TOC in the ME-TOC Population | 254 Participants |
95% CI: [-12.4, 0.7]
Secondary
By-Patient Sustained Microbiological Eradication at LFU Days in the ME-LFU Populations
Microbiological eradication is defined as number of participants with reduction of baseline urine pathogen(s) to \<10\^3 colony forming unit/milliliter (CFU/mL) and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Sustained Microbiological Eradication is defined participants with microbiologic eradication at the TOC and no subsequent urine culture after TOC demonstrating recurrence of the original baseline uropathogen at ≥10\^5 CFU/mL.
Time frame: Day 25 (LFU)
Population: ME-LFU population included participants who met the definitions of both the micro-ITT Population and CE Population and were defined for each visit for the analyses in the ME Population at each respective visit as outlined in the ERP
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TBPM-PI-HBr 600 mg | By-Patient Sustained Microbiological Eradication at LFU Days in the ME-LFU Populations | 234 Participants |
| Ertapenem 1 g | By-Patient Sustained Microbiological Eradication at LFU Days in the ME-LFU Populations | 216 Participants |
95% CI: [-8.5, 5.3]
Secondary
Clinical Cure at End-of-Treatment (EOT), TOC, and Sustained Clinical Cure at Late Follow-Up (LFU) Days in the Micro-ITT Populations
Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Sustained clinical cure is defined as participants who met criteria for clinical cure at TOC and remained free of signs and symptoms of cUTI or AP at LFU.
Time frame: Days 15 (EOT), Day 19 (TOC) and Day 25 (LFU)
Population: Microbiological intent-to-treat population (Micro-ITT) included all randomized participants with a confirmed diagnosis of cUTI or AP and a positive Screening urine culture defined as growth of one or two uropathogens at ≥10\^5 CFU/mL and/or positive Screening blood culture with isolation of one or more uropathogens.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TBPM-PI-HBr 600 mg | Clinical Cure at End-of-Treatment (EOT), TOC, and Sustained Clinical Cure at Late Follow-Up (LFU) Days in the Micro-ITT Populations | EOT | 446 Participants |
| TBPM-PI-HBr 600 mg | Clinical Cure at End-of-Treatment (EOT), TOC, and Sustained Clinical Cure at Late Follow-Up (LFU) Days in the Micro-ITT Populations | TOC | 418 Participants |
| TBPM-PI-HBr 600 mg | Clinical Cure at End-of-Treatment (EOT), TOC, and Sustained Clinical Cure at Late Follow-Up (LFU) Days in the Micro-ITT Populations | LFU | 398 Participants |
| Ertapenem 1 g | Clinical Cure at End-of-Treatment (EOT), TOC, and Sustained Clinical Cure at Late Follow-Up (LFU) Days in the Micro-ITT Populations | EOT | 410 Participants |
| Ertapenem 1 g | Clinical Cure at End-of-Treatment (EOT), TOC, and Sustained Clinical Cure at Late Follow-Up (LFU) Days in the Micro-ITT Populations | TOC | 392 Participants |
| Ertapenem 1 g | Clinical Cure at End-of-Treatment (EOT), TOC, and Sustained Clinical Cure at Late Follow-Up (LFU) Days in the Micro-ITT Populations | LFU | 377 Participants |
Comparison: Statistical Analysis 1 (EOT)95% CI: [-0.1, 3.4]
Comparison: Statistical Analysis 2 (TOC)95% CI: [-4, 2.8]
Comparison: Statistical Analysis 3 (LFU)95% CI: [-5.7, 2.6]
Secondary
Clinical Cure at EOT Days the Clinically Evaluable (CE-EOT) Populations
Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted.
Time frame: Day 15 (EOT)
Population: CE-EOT population is a subset which included participants who meet the definition for the ITT population, have no important protocol deviations that would affect the assessment of efficacy, and had an outcome assessed as clinical cure or clinical failure at EOT.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TBPM-PI-HBr 600 mg | Clinical Cure at EOT Days the Clinically Evaluable (CE-EOT) Populations | 673 Participants |
| Ertapenem 1 g | Clinical Cure at EOT Days the Clinically Evaluable (CE-EOT) Populations | 665 Participants |
95% CI: [-0.3, 2]
Secondary
Clinical Cure at EOT in the ME-EOT Populations
Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted.
Time frame: Day 15 (EOT)
Population: ME-EOT population is a subset which included participants who met the definitions of both the micro-ITT Population and CE Population and were defined for each visit for the analyses in the ME Population at each respective visit as outlined in the ERP.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TBPM-PI-HBr 600 mg | Clinical Cure at EOT in the ME-EOT Populations | 437 Participants |
| Ertapenem 1 g | Clinical Cure at EOT in the ME-EOT Populations | 394 Participants |
95% CI: [-0.2, 3.2]
Secondary
Clinical Cure at TOC Days in the ME-TOC Populations
Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted.
Time frame: Day 19 (TOC)
Population: ME-TOC population is a subset which included participants who met the definitions of both the micro-ITT Population and CE Population and were defined for each visit for the analyses in the ME Population at each respective visit as outlined in the ERP.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TBPM-PI-HBr 600 mg | Clinical Cure at TOC Days in the ME-TOC Populations | 390 Participants |
| Ertapenem 1 g | Clinical Cure at TOC Days in the ME-TOC Populations | 363 Participants |
95% CI: [-5.3, 0.8]
Secondary
Clinical Cure at TOC in the CE-TOC Populations
Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted.
Time frame: Day 19 (TOC)
Population: CE-TOC population is a subset which included participants who meet the definition for the ITT population, have no important protocol deviations that would affect the assessment of efficacy, and had an outcome assessed as clinical cure or clinical failure at TOC.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TBPM-PI-HBr 600 mg | Clinical Cure at TOC in the CE-TOC Populations | 611 Participants |
| Ertapenem 1 g | Clinical Cure at TOC in the CE-TOC Populations | 617 Participants |
95% CI: [-3.8, 0.6]
Secondary
Cmax in TBPM-PI-HBr Recipients in the PK Population
Time frame: Predose and post-dose at 0.25h, 0.5h, 1h, 2h, and 8h on Days 1 and 3
Population: PK population included participants treated with at least 1 dose of TBPM-PI-HBr with at least 1 analyzable plasma or urine PK sample. The data is reported only for TBPM-PI-HBr arm.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| TBPM-PI-HBr 600 mg | Cmax in TBPM-PI-HBr Recipients in the PK Population | Day 1 | 7.01 microgram per milliliter (μg/mL) |
| TBPM-PI-HBr 600 mg | Cmax in TBPM-PI-HBr Recipients in the PK Population | Day 3 | 7.21 microgram per milliliter (μg/mL) |
Secondary
Minimum Concentration (Cmin) in TBPM-PI-HBr Recipients in the PK Population
Time frame: Predose and post-dose at 0.25h, 0.5h, 1h, 2h, and 8h on Days 1 and 3
Population: PK population included subjects treated with at least 1 dose of TBPM-PI-HBr with at least 1 analyzable plasma or urine PK sample. The data is reported only for TBPM-PI-HBr arm.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| TBPM-PI-HBr 600 mg | Minimum Concentration (Cmin) in TBPM-PI-HBr Recipients in the PK Population | Day 1 | 0.706 μg/mL |
| TBPM-PI-HBr 600 mg | Minimum Concentration (Cmin) in TBPM-PI-HBr Recipients in the PK Population | Day 3 | 1.17 μg/mL |
Secondary
Overall Response (Combined Clinical Cure Plus Microbiological Eradication) At Test-Of-Cure (TOC) In The Microbiologically Evaluable (ME) - TOC Population
Overall response is participants with combined clinical cure and microbiological eradication. Clinical cure is defined as complete resolution or significant improvement of signs and symptoms of cUTI or acute pyelonephritis (AP) that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline.
Time frame: Day 19 (TOC)
Population: Microbiologically evaluable (ME) - TOC is a subset which included participants who met the definitions of both the micro-ITT Population and CE Population and were defined for each visit for the analyses in the ME Population at each respective visit as outlined in the evaluability review plan (ERP).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TBPM-PI-HBr 600 mg | Overall Response (Combined Clinical Cure Plus Microbiological Eradication) At Test-Of-Cure (TOC) In The Microbiologically Evaluable (ME) - TOC Population | 254 Participants |
| Ertapenem 1 g | Overall Response (Combined Clinical Cure Plus Microbiological Eradication) At Test-Of-Cure (TOC) In The Microbiologically Evaluable (ME) - TOC Population | 247 Participants |
95% CI: [-11.3, 1.9]
Secondary
Overall Response Rate (Combined Clinical Cure Plus Microbiological Eradication) at TOC In Subgroup Including Region
Overall response rate is percentage of participants with combined clinical cure plus microbiological eradication. Clinical cure is defined as complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \<10\^3 colony forming unit/milliliter (CFU/mL) and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. The point estimate and confidence interval (CI) is presented for Central and eastern Europe subgroup.
Time frame: Day 25 (LFU)
Population: Micro-ITT included all randomized participants with a confirmed diagnosis of cUTI or AP and a positive Screening urine culture defined as growth of one or two uropathogens at ≥10\^5 CFU/mL and/or positive Screening blood culture with isolation of one or more uropathogens. Number analyzed is number of participants with data available for analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TBPM-PI-HBr 600 mg | Overall Response Rate (Combined Clinical Cure Plus Microbiological Eradication) at TOC In Subgroup Including Region | Central and Eastern Europe | 58.9 percentage of participants |
| TBPM-PI-HBr 600 mg | Overall Response Rate (Combined Clinical Cure Plus Microbiological Eradication) at TOC In Subgroup Including Region | South Africa | 100 percentage of participants |
| TBPM-PI-HBr 600 mg | Overall Response Rate (Combined Clinical Cure Plus Microbiological Eradication) at TOC In Subgroup Including Region | United States | 0.0 percentage of participants |
| Ertapenem 1 g | Overall Response Rate (Combined Clinical Cure Plus Microbiological Eradication) at TOC In Subgroup Including Region | Central and Eastern Europe | 62.0 percentage of participants |
| Ertapenem 1 g | Overall Response Rate (Combined Clinical Cure Plus Microbiological Eradication) at TOC In Subgroup Including Region | South Africa | 0.0 percentage of participants |
| Ertapenem 1 g | Overall Response Rate (Combined Clinical Cure Plus Microbiological Eradication) at TOC In Subgroup Including Region | United States | 50.0 percentage of participants |
Comparison: Central and Eastern Europe95% CI: [-9.6, 3.5]
Secondary
Overall Response Rate (Combined Clinical Cure Plus Microbiological Eradication) at TOC In Subgroup Stratified Age Category
Overall response rate is percentage of participants with combined clinical cure plus microbiological eradication. Clinical cure is defined as complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline.
Time frame: Day 19 (TOC)
Population: Micro-ITT population included all randomized participants with a confirmed diagnosis of cUTI or AP and a positive Screening urine culture defined as growth of one or two uropathogens at ≥10\^5 CFU/mL and/or positive Screening blood culture with isolation of one or more uropathogens. Number analyzed is number of participants with data available for analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TBPM-PI-HBr 600 mg | Overall Response Rate (Combined Clinical Cure Plus Microbiological Eradication) at TOC In Subgroup Stratified Age Category | ≥18 to <65 years | 66.7 percentage of participants |
| TBPM-PI-HBr 600 mg | Overall Response Rate (Combined Clinical Cure Plus Microbiological Eradication) at TOC In Subgroup Stratified Age Category | ≥65 to <75 years | 49.2 percentage of participants |
| TBPM-PI-HBr 600 mg | Overall Response Rate (Combined Clinical Cure Plus Microbiological Eradication) at TOC In Subgroup Stratified Age Category | ≥75 years | 49.4 percentage of participants |
| Ertapenem 1 g | Overall Response Rate (Combined Clinical Cure Plus Microbiological Eradication) at TOC In Subgroup Stratified Age Category | ≥18 to <65 years | 65.3 percentage of participants |
| Ertapenem 1 g | Overall Response Rate (Combined Clinical Cure Plus Microbiological Eradication) at TOC In Subgroup Stratified Age Category | ≥65 to <75 years | 57.6 percentage of participants |
| Ertapenem 1 g | Overall Response Rate (Combined Clinical Cure Plus Microbiological Eradication) at TOC In Subgroup Stratified Age Category | ≥75 years | 56.9 percentage of participants |
95% CI: [-7.2, 9.9]
Comparison: ≥65 to \<75 years95% CI: [-20.6, 3.8]
Comparison: ≥75 years95% CI: [-23.8, 8.7]
Secondary
Overall Response Rate (Combined Clinical Cure Plus Microbiological Eradication) In Subgroup Including: Stratified Infection Category
Overall response rate is percentage of participants with combined clinical cure plus microbiological eradication. Clinical cure is defined as complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \<10\^3 colony forming unit/milliliter (CFU/mL) and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline.
Time frame: Day 19 (TOC)
Population: Micro-ITT population included all randomized participants with a confirmed diagnosis of cUTI or AP and a positive Screening urine culture defined as growth of one or two uropathogens at ≥10\^5 CFU/mL and/or positive Screening blood culture with isolation of one or more uropathogens. Number analyzed are the number of participants with data available for analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TBPM-PI-HBr 600 mg | Overall Response Rate (Combined Clinical Cure Plus Microbiological Eradication) In Subgroup Including: Stratified Infection Category | AP | 65.9 percentage of participants |
| TBPM-PI-HBr 600 mg | Overall Response Rate (Combined Clinical Cure Plus Microbiological Eradication) In Subgroup Including: Stratified Infection Category | cUTI | 51.6 percentage of participants |
| Ertapenem 1 g | Overall Response Rate (Combined Clinical Cure Plus Microbiological Eradication) In Subgroup Including: Stratified Infection Category | AP | 70.6 percentage of participants |
| Ertapenem 1 g | Overall Response Rate (Combined Clinical Cure Plus Microbiological Eradication) In Subgroup Including: Stratified Infection Category | cUTI | 53.2 percentage of participants |
Comparison: Overall response for participants with AP95% CI: [-13.5, 4.1]
Comparison: Overall response in participants with cUTI95% CI: [-11, 7.7]
Secondary
Rate of Clinical Relapse at the LFU Days in the Micro-ITT Population
Clinical relapse is participants who met criteria for clinical cure at TOC, but new signs and symptoms of cUTI or AP are present at the LFU Visit and the subject requires antibiotic therapy for the cUT. Clinical cure is defined as complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted.
Time frame: Day 25 (LFU)
Population: Micro-ITT population included all randomized participants with a confirmed diagnosis of cUTI or AP and a positive Screening urine culture defined as growth of one or two uropathogens at ≥10\^5 CFU/mL and/or positive Screening blood culture with isolation of one or more uropathogens.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TBPM-PI-HBr 600 mg | Rate of Clinical Relapse at the LFU Days in the Micro-ITT Population | 2.7 percentage of participants |
| Ertapenem 1 g | Rate of Clinical Relapse at the LFU Days in the Micro-ITT Population | 3.6 percentage of participants |
Secondary
Rates Of Superinfection And New Infection In The Micro-ITT Population
Superinfection was isolation of a new uropathogen at ≥105 CFU/mL (other than the original Baseline pathogen\[s\] from blood and/or urine) from a urine culture that was accompanied by clinical signs and symptoms of infection requiring alternative antimicrobial therapy (e.g., the participant was assessed by the investigator as a clinical failure) during the period up to and including EOT. New infection was isolation of a new uropathogen at ≥105 CFU/mL (other than the original baseline pathogen\[s\] from blood and/or urine) from a urine culture that was accompanied by clinical signs and symptoms of infection requiring alternative antimicrobial therapy (e.g., the participant was assessed by the Investigator as a clinical failure) in the period after EOT.
Time frame: Day 25 (LFU)
Population: Micro-ITT population included all randomized participants with a confirmed diagnosis of cUTI or AP and a positive Screening urine culture defined as growth of one or two uropathogens at ≥10\^5 CFU/mL and/or positive Screening blood culture with isolation of one or more uropathogens.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TBPM-PI-HBr 600 mg | Rates Of Superinfection And New Infection In The Micro-ITT Population | Superinfection | 0.2 percentage of participants |
| TBPM-PI-HBr 600 mg | Rates Of Superinfection And New Infection In The Micro-ITT Population | New Infection | 1.1 percentage of participants |
| Ertapenem 1 g | Rates Of Superinfection And New Infection In The Micro-ITT Population | Superinfection | 2.1 percentage of participants |
| Ertapenem 1 g | Rates Of Superinfection And New Infection In The Micro-ITT Population | New Infection | 1.9 percentage of participants |
Secondary
Sustained Clinical Cure at LFU in the CE-LFU Populations
Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Sustained clinical cure is defined as number of participants who met criteria for clinical cure at TOC and remained free of signs and symptoms of cUTI or AP at LFU.
Time frame: Day 25 (LFU)
Population: CE-LFU population is a subset which included participants who meet the definition for the ITT population, have no important protocol deviations that would affect the assessment of efficacy, and had an outcome assessed as clinical cure or clinical failure at LFU.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TBPM-PI-HBr 600 mg | Sustained Clinical Cure at LFU in the CE-LFU Populations | 556 Participants |
| Ertapenem 1 g | Sustained Clinical Cure at LFU in the CE-LFU Populations | 559 Participants |
95% CI: [-3.3, 2.3]
Secondary
Sustained Clinical Cure at LFU in the ME-LFU Population
Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Sustained clinical cure is defined as participants who met criteria for clinical cure at TOC and remained free of signs and symptoms of cUTI or AP at LFU.
Time frame: Day 25 (LFU)
Population: ME-LFU population is a subset which included participants who met the definitions of both the micro-ITT Population and CE Population and were defined for each visit for the analyses in the ME Population at each respective visit as outlined in the ERP.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TBPM-PI-HBr 600 mg | Sustained Clinical Cure at LFU in the ME-LFU Population | 360 Participants |
| Ertapenem 1 g | Sustained Clinical Cure at LFU in the ME-LFU Population | 329 Participants |
95% CI: [-5.1, 2.6]
Secondary
Systemic Clearance (CL) in TBPM-PI-HBr Recipients in the PK Population
Time frame: Predose and post-dose at 0.25h, 0.5h, 1h, 2h, and 8h on Days 1 and 3
Population: PK population included subjects treated with at least 1 dose of TBPM-PI-HBr with at least 1 analyzable plasma or urine PK sample. The data is reported only for TBPM-PI-HBr arm.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| TBPM-PI-HBr 600 mg | Systemic Clearance (CL) in TBPM-PI-HBr Recipients in the PK Population | Day 1 | 31.6 Litre per hour (L/h) |
| TBPM-PI-HBr 600 mg | Systemic Clearance (CL) in TBPM-PI-HBr Recipients in the PK Population | Day 3 | 31.6 Litre per hour (L/h) |
Secondary
Time (Days) to Defervescence in Micro-ITT Population With a Documented Fever at Screening or Day 1
Time to Defervescence (days) = date of first post-baseline temperature measure with maximum daily Temperature ≤38°C at the date of randomization.
Time frame: Day 25 (LFU)
Population: Micro-ITT population included all randomized participants with a confirmed diagnosis of cUTI or AP and a positive Screening urine culture defined as growth of one or two uropathogens at ≥10\^5 CFU/mL and/or positive Screening blood culture with isolation of one or more uropathogens. Overall number of participants analyzed are the participants with data available for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TBPM-PI-HBr 600 mg | Time (Days) to Defervescence in Micro-ITT Population With a Documented Fever at Screening or Day 1 | 2.2 days | Standard Deviation 1.33 |
| Ertapenem 1 g | Time (Days) to Defervescence in Micro-ITT Population With a Documented Fever at Screening or Day 1 | 2.2 days | Standard Deviation 1.4 |
p-value: 0.736Log Rank
Secondary
Time (Days) to Resolution or Improvement of Signs and Symptoms of cUTI and AP Present a Baseline in the Micro-ITT Populations
Time (days) to resolution or improvement of signs and symptoms of cUTI and AP present at baseline was defined as follows: date of the first visit at which all baseline signs/symptoms have improved by at least 1 grade with worsening of none and development of no new signs/symptoms of the index infection minus the date of randomization.
Time frame: Day 25 (LFU)
Population: Micro-ITT population included all randomized participants with a confirmed diagnosis of cUTI or AP and a positive Screening urine culture defined as growth of one or two uropathogens at ≥105 CFU/mL and/or positive Screening blood culture with isolation of one or more uropathogens.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TBPM-PI-HBr 600 mg | Time (Days) to Resolution or Improvement of Signs and Symptoms of cUTI and AP Present a Baseline in the Micro-ITT Populations | 4.1 days | Standard Deviation 3.85 |
| Ertapenem 1 g | Time (Days) to Resolution or Improvement of Signs and Symptoms of cUTI and AP Present a Baseline in the Micro-ITT Populations | 3.7 days | Standard Deviation 3.26 |
p-value: 0.044Log Rank