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Clinical Trial Summary

This phase 1b study is a double-blind, double-dummy, nitrofurantoin-controlled study designed to evaluate microbiological response at the test of cure (ToC) visit along with safety, tolerability and pharmacokinetic (PK) response following daily oral dosing for 5 days of GSK3882347 in an adult female with uncomplicated urinary tract infections (uUTI). Comparator nitrofurantoin will be included in the study to ensure unbiased reporting of safety events. The study will be separated into 2 cohorts. Cohort 1 consists of an inpatient treatment period and PK analysis at frequent timepoints. Cohort 2 includes an outpatient treatment period and PK analysis conducted less frequently, at key trough timepoints.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05138822
Study type Interventional
Source GlaxoSmithKline
Contact
Status Suspended
Phase Phase 1
Start date May 18, 2022
Completion date July 16, 2024

See also
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Completed NCT03354598 - Oral Sulopenem-etzadroxil/Probenecid Versus Ciprofloxacin for Uncomplicated Urinary Tract Infection in Adult Women Phase 3