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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)

NCT06059846 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1690

Last updated 2026-03-10

Study results available
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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.

Conditions

Interventions

DRUG

TBP-PI-HBr

TBP-PI-HBr film-coated immediate-release tablets.

DRUG

Imipenem-cilastatin

Sterile powder for reconstitution administered as IV.

DRUG

Dummy Infusion

0.9% sodium chloride administered as IV infusion.

DRUG

Dummy Tablets

TBP-PI-HBr matching dummy tablets.

Sponsors & Collaborators

Principal Investigators

  • David Hong, MD · Spero Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-21
Primary Completion
2025-01-27
Completion
2025-02-06
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Bosnia and Herzegovina
  • Brazil
  • Bulgaria
  • Croatia
  • Estonia
  • Georgia
  • Greece
  • Hungary
  • India
  • Latvia
  • Moldova
  • Poland
  • Romania
  • Serbia
  • Slovakia
  • South Africa
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06059846 on ClinicalTrials.gov