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Oral Sulopenem Versus Amoxicillin/Clavulanate for Uncomplicated Urinary Tract Infection in Adult Women

NCT05584657 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2229

Last updated 2024-11-20

Study results available
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Summary

Study 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.

Conditions

Interventions

DRUG

Sulopenem etzadroxil/probenecid

Oral sulopenem twice daily for 5 days

DRUG

Amoxicillin/clavulanate

Oral Augmentin twice daily for 5 days

Sponsors & Collaborators

  • Iterum Therapeutics, International Limited

    lead INDUSTRY

Principal Investigators

  • Sailaja Puttagunta, MD · Iterum Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-18
Primary Completion
2023-11-03
Completion
2023-11-21
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05584657 on ClinicalTrials.gov