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Carbapenem

TBP-PI-HBr 600 mg + Dummy Infusion for Urinary Tract Infection (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

PIVOT-PO 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.Check my eligibility

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.See study design

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.

PIVOT-PO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 10, 17, and 28

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants With Overall Response at the Test-of-Cure (TOC) Visit

Secondary outcome measures

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

+6 more

PIVOT-PO 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineIndustry Sponsor

4,755 Previous Clinical Trials

8,068,168 Total Patients Enrolled

Spero TherapeuticsLead Sponsor

22 Previous Clinical Trials

2,188 Total Patients Enrolled

Kamal Hamed, MDStudy DirectorSpero Therapeutics

1 Previous Clinical Trials

35 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment process currently in progress for participants of this research study?

"Affirmative. Information from clinicaltrials.gov indicates that this trial is actively seeking volunteers. The trial was first listed on December 21, 2023, and its most recent update was on March 6, 2024. A total of 2648 patients are being sought across four designated sites for enrollment in the study."

Answered by AI

Are there several facilities conducting this medical study in North America?

"At present, enrollment for this research is open at 4 sites including Belgrade, Chisinau, and Tbilisi among others. Opting for the site nearest to you is advisable to reduce travel obligations while taking part in the trial."

Answered by AI

Has the FDA sanctioned the use of TBP-PI-HBr 600 mg + Dummy Infusion?

"The safety evaluation for TBP-PI-HBr 600 mg + Placebo Infusion has been rated as a 3 by our experts at Power. This rating is based on the extensive safety data obtained from multiple rounds of assessments in this Phase 3 clinical trial, along with some evidence supporting its effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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)

2023. "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)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06059846.