TBP-PI-HBr

DRUG3 trials

Sponsors

Spero Therapeutics

Conditions

Acute PyelonephritisHealthy ParticipantsHealthy VolunteersUrinary Tract Infection

Phase 1

A Study to Compare Two Bioanalytical Assays for Tebipenem

CompletedNCT05856747

Spero TherapeuticsHealthy Volunteers

Start: 2023-05-04End: 2023-06-01Updated: 2024-03-27

A Study to Characterize Single and Repeat Dose Pharmacokinetics of Tebipenem-Pivoxil-Hydrobromide (TBP-PI-HBr) and Its Major Metabolite (SPR1349) in Healthy Participants

CompletedNCT06727136

Spero TherapeuticsHealthy Participants

Start: 2024-11-20End: 2025-04-22Updated: 2025-05-20

Phase 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)

CompletedNCT06059846

Spero TherapeuticsAcute Pyelonephritis, Urinary Tract Infection

Start: 2023-12-21End: 2025-02-06Updated: 2026-03-10

Related Papers

173. Oral Tebipenem Pivoxil Hydrobromide versus Intravenous Imipenem-Cilastatin in Patients with Complicated Urinary Tract Infections or Acute Pyelonephritis: Efficacy and Safety Results from the Phase 3 PIVOT-PO study

Open Forum Infectious Diseases2026-01-01