Sulopenem etzadroxil/probenecid for Urinary Tract Infections

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Urinary Tract Infections+3 More
Sulopenem etzadroxil/probenecid - Drug
Eligibility
18+
Female
What conditions do you have?
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Study Summary

IT001-310 is a clinical study which compares the effectiveness of oral sulopenem versus oral amoxicillin/clavulanate for the treatment of adult women with uncomplicated urinary tract infection.

Eligible Conditions
  • Urinary Tract Infections
  • Cystitis

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Urinary Tract Infections

Study Objectives

3 Primary · 10 Secondary · Reporting Duration: Day 12+/-1 day

Day 12+/-1 day
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
Percentage of Microbiologic Modified Intent to Treat (Micro-MITT) Participants with Overall Success
Bacteriuria
Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Participants With Clinical Success
Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Participants With Microbiologic 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 Asymptomatic Bacteriuria
Percentage of Microbiologic Modified Intent to Treat Susceptible (Micro-MITTS) Participants With Clinical Success
Percentage of Microbiologic Modified Intent to Treat Susceptible (Micro-MITTS) Participants With Microbiologic Success
Percentage of Microbiologic Modified Intent to Treat Susceptible (Micro-MITTS) Participants With Overall Success
Percentage of Modified Intent to Treat (MITT) Participants With Clinical Success

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Urinary Tract Infections

Trial Design

2 Treatment Groups

Amoxicillin/clavulanate
1 of 2
Sulopenem etzadroxil/probenecid
1 of 2
Active Control
Experimental Treatment

1966 Total Participants · 2 Treatment Groups

Primary Treatment: Sulopenem etzadroxil/probenecid · No Placebo Group · Phase 3

Sulopenem etzadroxil/probenecid
Drug
Experimental Group · 1 Intervention: Sulopenem etzadroxil/probenecid · Intervention Types: Drug
Amoxicillin/clavulanate
Drug
ActiveComparator Group · 1 Intervention: Amoxicillin/clavulanate · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 12+/-1 day

Who is running the clinical trial?

Iterum Therapeutics, International LimitedLead Sponsor
7 Previous Clinical Trials
3,990 Total Patients Enrolled
5 Trials studying Urinary Tract Infections
3,316 Patients Enrolled for Urinary Tract Infections
Sailaja Puttagunta, MDStudy DirectorIterum Therapeutics

Eligibility Criteria

Age 18+ · Female Participants · 3 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 26th, 2021

Last Reviewed: October 29th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.