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Antibiotic

GSK3882347 for Urinary Tract Infection (UTI)

Phase 1
Recruiting
Research Sponsored by GlaxoSmithKline
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 2 days
Treatment Varies
Follow Up day 10 to day 13

Summary

This trial tests a new medication, GSK3882347, to treat urinary tract infections in adult women. The study will see if the medication can effectively clear the infection and check for any side effects. Participants will take the medication for a short period, and researchers will compare it to an existing treatment to ensure accurate results.

Who is the study for?
This trial is for adult women aged 18-70 with uncomplicated urinary tract infections (uUTI), not pregnant or breastfeeding, and using effective contraception. They must have symptoms like pain during urination, frequent urge to urinate, or lower abdominal pain. Women with immune issues, other diseases causing similar symptoms, urinary anomalies, severe kidney problems, recent antimicrobial treatment or high alcohol intake are excluded.
What is being tested?
The study tests GSK3882347's safety and effectiveness against uUTI compared to Nitrofurantoin and a placebo over 5 days. It includes two groups: one staying in the hospital for detailed daily checks (Cohort 1) and another treated as outpatients with less frequent checks (Cohort 2).
What are the potential side effects?
Possible side effects of GSK3882347 aren't specified but may include typical antibiotic-related issues such as digestive discomfort, allergic reactions or skin rashes. Nitrofurantoin can cause lung problems, liver toxicity or nerve damage.

Timeline

Screening ~ 2 days
Treatment ~ Varies
Follow Up ~day 10 to day 13
This trial's timeline: 2 days for screening, Varies for treatment, and day 10 to day 13 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Numbers of participants with microbiological response (responder/non-responder of GSK3882347) at the test of cure (TOC) visit
Secondary study objectives
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Number of participants with clinically significant change from baseline in clinical chemistry
Number of participants with clinically significant change from baseline in hematology parameters
+3 more

Side effects data

From 2021 Phase 1 trial • 61 Patients • NCT04488770
17%
Head injury
17%
Presyncope
17%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 1: Single Dose Placebo
Part 1: Single Dose GSK3882347 15 mg
Part 1: Single Dose GSK3882347 50 mg
Part 1: Single Dose GSK3882347 500 mg
Part 1: Single Dose GSK3882347 900 mg
Part 2: Repeat Dose Placebo
Part 2: Repeat Dose GSK3882347 50 mg
Part 2: Repeat Dose GSK3882347 150 mg
Part 1: Single Dose GSK3882347 150 mg
Part 2: Repeat Dose GSK3882347 900 mg
Part 1: Single Dose GSK3882347 250 mg
Part 1: Single Dose GSK3882347 250 mg Fed
Part 2: Repeat Dose GSK3882347 500 mg

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: GSK3882347 + PlaceboExperimental Treatment2 Interventions
Participants will be administered GSK3882347 plus placebo.
Group II: Nitrofurantoin+ PlaceboActive Control2 Interventions
Participants will be administered nitrofurantoin plus placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GSK3882347
2020
Completed Phase 1
~90
Placebo
1995
Completed Phase 3
~2670

Find a Location

Logistics

Travel, including flights, are covered

Your expenses for travel tickets for this trial will be reimbursed.

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,815 Previous Clinical Trials
8,384,448 Total Patients Enrolled
1 Trials studying Urinary Tract Infection
2,648 Patients Enrolled for Urinary Tract Infection
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,608 Previous Clinical Trials
6,145,342 Total Patients Enrolled
~4 spots leftby Jan 2025
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