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Carbapenem

Oral Tebipenem vs IV Imipenem for Urinary Tract Infections (PIVOT-PO Trial)

Phase 3
Recruiting
Research Sponsored by Spero Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 10, 17, and 28
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial aims to compare how well an oral medication called TBP-PI-HBr works against a standard intravenous medication called imipenem-cilastatin in treating urinary tract or abdominal infections

Who is the study for?
Adults diagnosed with complicated urinary tract infection (cUTI) or acute pyelonephritis (AP), showing signs of infection in urine tests. Participants must be expected to survive the treatment duration with proper care. People are excluded if they don't meet these health criteria.
What is being tested?
The trial is testing oral TBP-PI-HBr against IV imipenem-cilastatin for treating cUTI or AP. The goal is to see which treatment better clears the infection and symptoms at a follow-up visit after therapy.
What are the potential side effects?
Possible side effects include allergic reactions, gastrointestinal issues like nausea or diarrhea, potential kidney or liver function changes, and local reactions at infusion sites for those receiving IV drugs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 10, 17, and 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 10, 17, and 28 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Overall Response at the Test-of-Cure (TOC) Visit
Secondary study objectives
Number of Participants With Clinical Response at the EOT, TOC and LFU Visits
Number of Participants With Clinical Response at the EOT, TOC, and LFU Visits in Participants With Drug-resistant Enterobacterales
Number of Participants With Microbiological Response at the EOT, TOC and LFU Visits
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TBP-PI-HBr 600 mg + Dummy InfusionExperimental Treatment2 Interventions
Participants will receive TBP-PI-HBr 600 mg, orally and dummy infusion IV, every 6 hours from Days 1 through 10.
Group II: Imipenem-cilastatin 500 mg + Dummy TabletsActive Control2 Interventions
Participants will receive imipenem-cilastatin 500 mg, IV and matched dummy tablets, orally, every 6 hours from Days 1 through 10.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TBP-PI-HBr
2023
Completed Phase 1
~20
Dummy Infusion
2019
Completed Phase 3
~1380

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineIndustry Sponsor
4,807 Previous Clinical Trials
8,378,670 Total Patients Enrolled
Spero TherapeuticsLead Sponsor
22 Previous Clinical Trials
2,188 Total Patients Enrolled
David Hong, MDStudy DirectorSpero Therapeutics
7 Previous Clinical Trials
349 Total Patients Enrolled
~1324 spots leftby Nov 2025
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