Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06059846 | 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) | PHASE3 | COMPLETED | 1,690 | — | — | Dec 21, 2023 | Feb 6, 2025 | Mar 10, 2026 | 85 | United States, Argentina +17 |
Overall response includes combined clinical cure plus microbiological eradication. Clinical cure is defined as a complete resolution or significant improvement of signs and symptoms of cUTI or AP present at baseline and no new symptoms, such that no further antibacterial therapy is warranted, and participant is alive. Microbiological eradication (favorable microbiological response) is defined as a reduction of baseline uropathogens to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline and participant is alive.
| Arm | Type | Description |
|---|---|---|
| TBP-PI-HBr | EXPERIMENTAL | Participants received TBP-PI-HBr 600 milligrams (mg), two x 300mg film-coated tablets, orally (PO) and a dummy infusion intravenously (IV), every 6 hours (q6h) from Day 1 through Day 10. Participants with estimated baseline creatinine clearance (CrCl) greater than (\>) 30 millilitres per minute (mL/min) and less than or equal to (≤) 50 mL/min received TBP-PI-HBr 300 mg q6h. |
| Imipenem-cilastatin | ACTIVE_COMPARATOR | Participants received imipenem-cilastatin 500 mg, IV and matched dummy tablets, PO, q6h from Day 1 through Day 10. Dose adjustments for imipenem-cilastatin were made for participants with estimated baseline CrCl less than (\<) 90mL/min per approved imipenem-cilastatin package insert. Participants with baseline CrCl levels greater than or equal to (≥) 60 to \< 90 mL/min were administered imipenem-cilastatin, 400 mg IV q6h and participants with baseline CrCl levels \>30 to \<60 mL/min, were administered 300mg IV, q6h. |
| Name | Type | Description |
|---|---|---|
| TBP-PI-HBr | DRUG | TBP-PI-HBr film-coated immediate-release tablets. |
| Imipenem-cilastatin | DRUG | Sterile powder for reconstitution administered as IV. |
| Dummy Infusion | DRUG | 0.9% sodium chloride administered as IV infusion. |
| Dummy Tablets | DRUG | TBP-PI-HBr matching dummy tablets. |
Inclusion Criteria: 1. Have a diagnosis of cUTI or AP. 2. 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: 1. at least 10 white blood cells (WBCs) per high power field ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 2 | PHASE1 | Gepotidacin, Candidate UTI vaccine low dose formulation 1, Candidate UTI vaccine HTD formulation 2 |
| CorMedix Inc. | CRMD | 1 | PHASE2 | Meropenem-Vaborbactam, Antibiotics |
| Pfizer Inc. | PFE | 1 | — | Undisclosed |
| QIAGEN NV | QGEN | 1 | — | Undisclosed |