Study to Assess the Efficacy, Safety and Pharmacokinetics of Orally Administered Tebipenem Pivoxi… (NCT03788967) | Clinical Trial Compass
CompletedPhase 3
Study to Assess the Efficacy, Safety and Pharmacokinetics of Orally Administered Tebipenem Pivoxil Hydrobromide (SPR994) Compared to Intravenous Ertapenem in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
United States, Bulgaria1,372 participantsStarted 2019-06-03
Plain-language 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).
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male and female participants at least 18 years of age.
✓. Able to provide informed consent.
✓. 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.
✓. Have a diagnosis of cUTI or AP as defined below:
✓. 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:
✓. At least 10 WBCs per high power field (hpf) in urine sediment.
✓. At least 10 WBCs per cubic millimeter (mm3) in unspun (non-centrifuged) urine.
✓. Positive leukocyte esterase (LE) on urinalysis. Note: Participants could be randomized and administered investigational product (IP) prior to knowledge of urine culture results.
Exclusion criteria
✕. 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:
✕. Perinephric or renal corticomedullary abscess.
✕. Uncomplicated urinary tract infection (cUTI) - (acute cystitis that does not meet the cUTI disease definition, see Inclusion Criterion 4a).
What they're measuring
1
Overall Response (Combined Clinical Cure and Microbiological Eradication) at Test-of-Cure (TOC) in Micro Intent-to-Treat Population
Timeframe: Day 19 (TOC)
2
Number of Participants With Treatment Emergent Adverse Events (TEAEs) in The Safety Population
Timeframe: From the first dose of administration up to Day 25 post-treatment ± 2 days (up to approximately 27 days)