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Beta-lactamase inhibitor

Sulopenem etzadroxil/probenecid for Urinary Tract Infection (REASSURE Trial)

Phase 3
Waitlist Available
Research Sponsored by Iterum Therapeutics, International Limited
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 day 12+/-1 day
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial compares two antibiotics to treat urinary tract infections in adult women.

Eligible Conditions
  • Urinary Tract Infection
  • Bladder Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 12+/-1 day
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 12+/-1 day for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Microbiologic Modified Intent to Treat (Micro-MITT) Participants with Overall Success
Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Participants With Overall Success
Percentage of Microbiologic Modified Intent to Treat Susceptible (Micro-MITTS) Participants With Overall Success
Secondary study objectives
Percentage of Microbiologic Modified Intent to Treat (Micro-MITT) Participants With Asymptomatic Bacteriuria
Percentage of Microbiologic Modified Intent to Treat (Micro-MITT) Participants With Clinical Success
Percentage of Microbiologic Modified Intent to Treat (Micro-MITT) Participants With Microbiologic Success
+7 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: Sulopenem etzadroxil/probenecidExperimental Treatment1 Intervention
Sulopenem etzadroxil/probenecid 500 mg/500 mg PO twice daily for 5 days
Group II: Amoxicillin/clavulanateActive Control1 Intervention
Amoxicillin/clavulanate PO twice daily for 5 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sulopenem etzadroxil/probenecid
2022
Completed Phase 3
~2230

Find a Location

Who is running the clinical trial?

Iterum Therapeutics, International LimitedLead Sponsor
7 Previous Clinical Trials
3,990 Total Patients Enrolled
Sailaja Puttagunta, MDStudy DirectorIterum Therapeutics

Media Library

Amoxicillin/clavulanate (Beta-lactamase inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05584657 — Phase 3
~743 spots leftby Nov 2025
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