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New antibiotic GSK3882347 tested for UTIs in early trial

NCT ID NCT05138822

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tested an experimental antibiotic called GSK3882347 in 140 women with uncomplicated urinary tract infections (UTIs). Participants received either the new drug, a standard antibiotic (nitrofurantoin), or a placebo for 5 days. The study measured how well the drug cleared bacteria from urine and monitored for side effects. Results will help decide if larger studies are warranted.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GSK3882347 (an experimental antibiotic)
What this could lead to
If successful, this could lead to a new antibiotic option for uncomplicated urinary tract infections in women.
What could go wrong
This is an early phase 1b trial with only 140 participants, so safety and effectiveness are not yet proven. The drug may not work better than existing treatments or could have unexpected side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

140 people

The number who actually took part.

Started

May 2022

Finished

Dec 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants must be greater than or equal to (\>=)18 years of age and less than or equal to (\<=)70 years * The participant has 2 or more of the following clinical signs and symptoms of uncomplicated urinary tract infections (uUTI) with onset less than (\<) 96 hours of the screening assessment: dysuria, frequency, urgency, or lower abdominal pain * Participant has nitrite OR pyuria (≥ 10 white blood cells/ cubic millimeter \[WBC/mm\^3\], OR \> 5 WBC/high power field \[HPF\]) OR the presence of 2+ leukocyte esterase from a pre-treatment clean-catch midstream urine sample * Participants with body mass index (BMI) \>= 19.0 kilograms per square meter (kg/m\^2) * A female participant is eligible to participate who is not pregnant (as confirmed by a highly sensitive pregnancy test before the first dose of study intervention) or breastfeeding and one of the following conditions apply: 1) Woman participant of non-childbearing potential (WONCBP) Or 2) Woman participant of childbearing potential (WOCBP) using a contraceptive method that is highly effective, with a failure rate of \< 1 percentage (%), during the study intervention period and up to 5 days post intervention * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and protocol. Exclusion Criteria: * The participant has a BMI \>= 40.0 kg/ m\^2 or a BMI \>=35.0 kg/ m\^2 with obesity related health conditions such as high blood pressure or uncontrolled diabetes (non-fasting glucose value \>300 milligram/deciliter \[mg/dL\]) * The participant is immunocompromised or has altered immune defenses that may predispose the participant to a higher risk of treatment failure and/or complications * The participant has symptoms known or suspected to be caused by another disease process, such as asymptomatic bacteriuria, overactive bladder, chronic incontinence, or chronic interstitial cystitis * The participant has an anatomical or physiological anomaly that predisposes the participant to UTIs or may be a source of persistent bacterial colonization, including calculi, obstruction of the urinary tract, primary renal disease, or neurogenic bladder, or the participant has a history of anatomical or functional abnormalities of the urinary tract * The participant has an indwelling catheter, nephrostomy, ureteral stent, or other foreign material in the urinary tract * The participant who, in the opinion of the investigator, has an otherwise complicated UTI, an active upper UTI (e.g., pyelonephritis, urosepsis), signs and symptoms onset \>=96 hours before the screening assessment, or a temperature \>=101-degree Fahrenheit (°F) (\>=38 degree Celsius \[°C\]), flank pain, chills, or any other manifestations suggestive of upper UTI * The participant has anuria, oliguria, or significant impairment of renal function * The participant presents at enrollment with a suspected sexually transmitted infection * A positive confirmation of Coronavirus Disease 2019 (COVID-19) infection, or high clinical index of suspicion for COVID-19 * The participant has received treatment with other systemic antimicrobials or systemic antifungals within 1 week or 10 weeks for dalbavancin or oritavancin before study entry. * Regular alcohol consumption within 6 months prior to the study with an average weekly intake of \>14 units for females and one unit is equivalent to approximately 8 g of alcohol: a half-pint (250 mL) of beer, one glass (125 mL) of wine or one (35 mL) measure of spirits * Unable to take nitrofurantoin. E.g. hypersensitivity to the active substance

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • GSK Investigational Site

    Anniston, Alabama, 36207, United States

  • GSK Investigational Site

    Lomita, California, 90717, United States

  • GSK Investigational Site

    Modesto, California, 95350-5365, United States

  • GSK Investigational Site

    Doral, Florida, 33166, United States

  • GSK Investigational Site

    Miami, Florida, 33186, United States

  • GSK Investigational Site

    Miami Lakes, Florida, 33016-1507, United States

  • GSK Investigational Site

    Palmetto Bay, Florida, 33157, United States

  • GSK Investigational Site

    Sweetwater, Florida, 33172, United States

  • GSK Investigational Site

    Chicago, Illinois, 60643, United States

  • GSK Investigational Site

    The Bronx, New York, 10456, United States

  • GSK Investigational Site

    Smithfield, Pennsylvania, 15478, United States

  • GSK Investigational Site

    Austin, Texas, 78705, United States

  • GSK Investigational Site

    Dallas, Texas, 75230, United States

  • GSK Investigational Site

    Houston, Texas, 77061, United States

  • GSK Investigational Site

    Missouri City, Texas, 77459, United States

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