A Study of Oral Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr) Compared to Intravenous Imipenem-cila… (NCT06059846) | Clinical Trial Compass
CompletedPhase 3
A Study of Oral Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr) Compared to Intravenous Imipenem-cilastatin in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
United States, Argentina1,690 participantsStarted 2023-12-21
Plain-language summary
The primary purpose of this study is to assess the efficacy of oral TBP-PI-HBr as compared with intravenous (IV) imipenem-cilastatin with respect to the overall response (combined clinical cure plus microbiological eradication) at the Test-of-Cure (TOC) visit in hospitalized adult participants (greater than or equal to (≥)18 years of age) with cUTI or AP.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Have a diagnosis of cUTI or AP.
✓. Have an adequate urine specimen for evaluation and culture obtained within 24 hours prior to randomization with evidence of pyuria that includes at least one of the following:
✓. at least 10 white blood cells (WBCs) per high power field (HPF) in urine sediment
✓. at least 10 WBCs per millimeters cubed (mm\^3) in unspun urine
✓. positive leukocyte esterase (LE) on urinalysis Note: Participants may be randomized and administered study drug prior to knowledge of urine culture results, but pyuria must be documented.
✓. Expectation, in the judgment of the Investigator, that the participant will survive with effective antimicrobial therapy and appropriate supportive care for the anticipated duration of the study.
Exclusion criteria
✕. Presence of any known or suspected disease or condition that may confound the assessment of efficacy.
✕. Gross hematuria requiring intervention other than administration of study drug or removal/placement of urinary tract instrumentation.
✕. Urinary tract surgery within 7 days prior to randomization or urinary tract surgery planned during the study period.
✕. Creatinine clearance (CrCl) of ≤30 milliliters per minute (mL/min), as estimated by the Cockcroft-Gault formula.
✕. Anticipated concomitant use of non-study antimicrobial drug therapy between randomization and the LFU visit that would potentially effect outcome evaluations of cUTI/AP.
What they're measuring
1
Number of Participants With Overall Response at the Test-of-Cure (TOC) Visit in the Microbiological Intent-to-Treat (Micro-ITT) Population
✕. Receipt of a potentially effective antimicrobial within 72 hours prior to study randomization.
✕. Severe hepatic impairment at Screening, as evidenced by alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>5×upper limit of normal (ULN) or total bilirubin \>3×ULN, or clinical signs of cirrhosis or end-stage hepatic disease (e.g., ascites, hepatic encephalopathy).