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) (PIVOT-PO)
A Phase 3, Randomized, Double-blind, Double-dummy, Multicenter, Multinational Study to Assess the Efficacy and Safety of Orally Administered Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr) Compared to Intravenously Administered Imipenem-cilastatin in Patients With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
Sponsor: GlaxoSmithKline
Listed as NCT06059846, this PHASE3 trial focuses on Acute Pyelonephritis and Urinary Tract Infection and remains completed. Sponsored by GlaxoSmithKline, it has been updated 19 times since 2023, reflecting substantial change activity. This study is part of the global effort to build evidence for infectious disease interventions.
Status Flow
Change History
19 versions recorded-
Mar 2026 — Present [monthly]
Completed PHASE3
-
Dec 2025 — Mar 2026 [monthly]
Completed PHASE3
-
Sep 2025 — Dec 2025 [monthly]
Completed PHASE3
-
Aug 2025 — Sep 2025 [monthly]
Completed PHASE3
Status: Recruiting → Completed
-
Jun 2025 — Aug 2025 [monthly]
Recruiting PHASE3
▶ Show 14 earlier versions
-
May 2025 — Jun 2025 [monthly]
Recruiting PHASE3
-
Apr 2025 — May 2025 [monthly]
Recruiting PHASE3
-
Dec 2024 — Apr 2025 [monthly]
Recruiting PHASE3
-
Nov 2024 — Dec 2024 [monthly]
Recruiting PHASE3
-
Oct 2024 — Nov 2024 [monthly]
Recruiting PHASE3
-
Sep 2024 — Oct 2024 [monthly]
Recruiting PHASE3
-
Aug 2024 — Sep 2024 [monthly]
Recruiting PHASE3
-
Jul 2024 — Aug 2024 [monthly]
Recruiting PHASE3
-
Jun 2024 — Jul 2024 [monthly]
Recruiting PHASE3
-
May 2024 — Jun 2024 [monthly]
Recruiting PHASE3
-
Apr 2024 — May 2024 [monthly]
Recruiting PHASE3
-
Mar 2024 — Apr 2024 [monthly]
Recruiting PHASE3
-
Feb 2024 — Mar 2024 [monthly]
Recruiting PHASE3
Status: Not Yet Recruiting → Recruiting
-
Oct 2023 — Feb 2024 [monthly]
Not Yet Recruiting PHASE3
First recorded
Eligibility Summary
No eligibility information available.
Contact Information
- GlaxoSmithKline
- Spero Therapeutics
For direct contact, visit the study record on ClinicalTrials.gov .