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Antibiotic

GSK3882347 for Urinary Tract Infection (UTI)

Phase 1
Waitlist Available
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
Awards & highlights

Study Summary

This trial is testing a new drug, GSK3882347, to see if it is effective and safe for treating urinary tract infections in women. The trial is double-blind, meaning neither the participants nor the researchers will know who is receiving the new drug and who is receiving the standard treatment drug, nitrofurantoin, until the trial is over. The trial is also double-dummy, meaning that both the new drug and the standard treatment will be given in a way that neither the participants nor the researchers will know which is which. The trial will be conducted in two cohorts: inpatient and outpatient. During the inpatient period

Eligible Conditions
  • Urinary Tract Infection (UTI)

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Numbers of participants with microbiological response (responder/non-responder of GSK3882347) at the test of cure (TOC) visit
Secondary outcome measures
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Number of participants with clinically significant change from baseline in 12- lead Electrocardiogram (ECG) findings
Number of participants with clinically significant change from baseline in clinical chemistry
+5 more

Side effects data

From 2021 Phase 1 trial • 61 Patients • NCT04488770
17%
Headache
17%
Presyncope
17%
Head injury
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 1: Single Dose Placebo
Part 1: Single Dose GSK3882347 15 mg
Part 2: Repeat Dose Placebo
Part 2: Repeat Dose GSK3882347 50 mg
Part 1: Single Dose GSK3882347 50 mg
Part 1: Single Dose GSK3882347 150 mg
Part 1: Single Dose GSK3882347 250 mg
Part 1: Single Dose GSK3882347 250 mg Fed
Part 2: Repeat Dose GSK3882347 150 mg
Part 2: Repeat Dose GSK3882347 500 mg
Part 1: Single Dose GSK3882347 500 mg
Part 1: Single Dose GSK3882347 900 mg
Part 2: Repeat Dose GSK3882347 900 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
~70
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
4,751 Previous Clinical Trials
8,067,392 Total Patients Enrolled
1 Trials studying Urinary Tract Infection
2,648 Patients Enrolled for Urinary Tract Infection
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,850 Total Patients Enrolled

Frequently Asked Questions

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

Are there other studies which have examined the impact of GSK3882347 on patients?

"Currently, 7 trials are in progress regarding GSK3882347 with 1 trial at Phase 3. Several of these clinical experiments occur around Cornellà De Llobregat, Catalonia whereas 33 other locations conduct research about this medication."

Answered by AI

What is the scope of this research project in regards to location within the state?

"Currently, 5 locations are enrolling participants in this clinical trial. These sites can be found in Austin, Anniston, La Mesa and a couple of other places. To avoid excessive travel costs it is advisable to select the closest centre possible if you decide to partake."

Answered by AI

Is enrollment open to individuals younger than 75 years of age for this medical research?

"According to the enrollment guidelines of this trial, individuals between 18 and 70 may be considered for inclusion. Notably, there are 205 clinical trials designed for those younger than 18 years old and 628 studies available for seniors aged 65 or older."

Answered by AI

Is GSK3882347 a risk to patient safety?

"With limited clinical data to support safety and efficacy, GSK3882347 was rated a 1 on our team's scale."

Answered by AI

Approximately how many individuals are engaged in this research?

"Affirmative. As evidenced on clinicaltrials.gov, this medical research is still recruiting volunteers for its trial which was first uploaded on May 18th 2022 and last updated November 11th 2022. The project needs 80 participants from 5 different locations in total."

Answered by AI

Is this trial still open and accepting participants?

"The details on clinicaltrials.gov reveals that this trial is currently welcoming participants, with the initial posting taking place on May 18th 2022 and most recent update occurring November 11th of the same year."

Answered by AI

Who is eligible to apply for participation in this clinical study?

"The requirements for this trial state that participants must be aged between 18 and 70, with a communicable illness. 80 individuals are being sought to contribute to the research."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
California
Illinois
How old are they?
65+
18 - 65
What site did they apply to?
GSK Investigational Site
GSK Investigational Site, Florida
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I am interested in helping to find non-antibiotic choices to treat infections.
PatientReceived 1 prior treatment

How responsive is this trial?

Most responsive sites:
  1. GSK Investigational Site: < 48 hours
Average response time
  • < 2 Days
Typically responds via
Email
~27 spots leftby Apr 2025