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Beta-lactamase inhibitor

Sulopenem etzadroxil/probenecid for Bladder 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

REASSURE Trial Summary

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

Eligible Conditions
  • Bladder Infection
  • Urinary Tract Infection

REASSURE Trial 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

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

REASSURE 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

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

Frequently Asked Questions

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

Could you inform me of how many locations are participating in this experiment?

"Currently, this experiment is being conducted at 50 different sites. While the primary locations are in Bronx, Summerville and Plano, there are also many other options located throughout to make participation more convenient for a greater number of people."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
North Carolina
California
Other
What site did they apply to?
Medical Facility
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
1
3+
0

Why did patients apply to this trial?

To stop having my UTI's. To find a new medication to help me. I really think i would benifit from this pleaae reach out.
PatientReceived 1 prior treatment
Because I’m tired of getting them and only a few antibiotics work for me. Want treatment near my home in Covington. Tired of constant bathroom visits.
PatientReceived 1 prior treatment

How responsive is this trial?

Most responsive sites:
  1. Medical Facility: < 24 hours
Average response time
  • < 2 Days
Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Oral Sulopenem Versus Amoxicillin/Clavulanate for Uncomplicated Urinary Tract Infection in Adult Women
2022. "Oral Sulopenem Versus Amoxicillin/Clavulanate for Uncomplicated Urinary Tract Infection in Adult Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05584657.
~892 spots leftby Apr 2025
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