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New antibiotic shows promise for fast UTI symptom relief in women

NCT ID NCT06597344

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This completed Phase 3 trial tested the antibiotic gepotidacin in 97 adolescent and adult women with uncomplicated urinary tract infections (UTIs). The goal was to see if symptoms like pain and urgency improved within 24 hours. Researchers measured symptom scores and safety. The study was open-label, meaning everyone knew they were getting the drug, and there was no placebo group.

What this could mean

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

Active substance
gepotidacin
What this could lead to
If successful, this could provide a new oral antibiotic option for quickly easing UTI symptoms in women and teens.
What could go wrong
This is a single-arm, open-label study with no placebo comparison, so results may be less reliable. The trial is also small (97 participants) and completed, so further studies may be needed.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

97 people

The number who actually took part.

Started

Oct 2024

Finished

Mar 2025

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

12 years and older

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 having \>=12 years of age at the time of signing the informed consent/assent and have a body weight \>=40 kilograms (kg). * The participant has 2 or more of the following clinical signs and symptoms of acute cystitis with onset \<96 hours prior to study entry: dysuria, frequency, urgency, or lower abdominal pain. * The participant has nitrite or pyuria (presence of 3 plus (+)/large leukocyte esterase) on a urine dipstick test from a pre-treatment clean-catch midstream urine sample. * The participant is capable of giving signed informed consent/assent. * The participant is female. Exclusion Criteria: * The participant resides in a nursing home or dependent care type-facility. * The participant has a body mass index \>=40.0 kilogram per meter square (kg/m\^2) or a body mass index \>=35.0 kg/m\^2 and is experiencing obesity-related health conditions such as uncontrolled high blood pressure or uncontrolled diabetes. * The participant has a history of sensitivity to the study treatment, or components thereof, or a history of a drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates her participation. * The participant is immunocompromised or has altered immune defences that may predispose the participant to a higher risk of treatment failure and/or complications. * The participant has any of the following: * Poorly controlled asthma or chronic obstructive pulmonary disease; Acute severe pain, Active peptic ulcer disease; Parkinson disease; Myasthenia gravis; * A history of seizure disorder requiring medications for control (this does not include a history of childhood febrile seizures) Or * Any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion of the study intervention. * The participant, in the judgment of the investigator, would not be able or willing to comply with the protocol or complete study follow-up. * The participant has a serious underlying disease that could be imminently life threatening, or the participant is unlikely to survive for the duration of the study period. * The participant has acute cystitis that is known or suspected to be due to fungal, parasitic, or viral pathogens; or known or suspected to be due to Pseudomonas aeruginosa or Enterobacterales (other than Escherichia coli) as the contributing pathogen. * The participant has symptoms known or suspected to be caused by another disease process, such as overactive bladder, chronic incontinence, or chronic interstitial cystitis, that may interfere with the clinical efficacy assessments or preclude complete resolution of uUTI symptoms. * 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 or stricture of the urinary tract, primary renal disease (for example \[e.g.\], polycystic renal disease), or neurogenic bladder, or the participant has a history of anatomical or functional abnormalities of the urinary tract (e.g., chronic vesico-ureteral reflux, detrusor insufficiency). * The participant has an indwelling catheter, nephrostomy, ureter 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 symptom onset \>=96 hours before study entry, or a temperature \>=101.4 degree Fahrenheit (\>=38 Degrees Celsius \[°C\]), flank pain, chills, or any other manifestations suggestive of upper UTI. * The participant has known anuria, oliguria, or significant impairment of renal function (creatinine clearance \<30 milliliters per minute (mL/min) or clinically significant elevated serum creatinine as determined by the investigator). * The participant presents with vaginal discharge at Baseline (e.g., suspected sexually transmitted disease). * The participant has congenital long QT syndrome or known prolongation of the QTc interval. * The participant has uncompensated heart failure. * The participant has severe left ventricular hypertrophy. * The participant has a family history of QT prolongation or sudden death. * The participant has a recent history of vasovagal syncope or episodes of symptomatic bradycardia or brady arrhythmia within the last 12 months. * The participant is taking QT-prolonging drugs or drugs known to increase the risk of torsade de pointes (TdP) per the www.crediblemeds.org. "Known Risk of TdP" category at the time of her Baseline Visit, which cannot be safely discontinued from the Baseline Visit to the TOC Visit; or the participant is taking a strong cytochrome P450 enzyme 3A4 (CYP3A4) inhibitor or a strong P-gp inhibitor * The participant has a mean triplicate QTc \>450 msec or a mean triplicate QTc \>480 msec for participants with bundle-branch block. * The participant has a documented or recent history of uncorrected hypokalemia within the past 3 months. * The participant has a known ALT value \>2 times upper limit of normal (ULN). * The participant has a known bilirubin value \>1.5 times ULN (isolated bilirubin \>1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35 percent \[%\]). * The participant has a current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones), including symptomatic viral hepatitis or moderate-to-severe liver insufficiency (Child Pugh class B or C). * The participant has received treatment with other systemic antimicrobials or systemic antifungals within 1 week before study entry. * The participant plans to use any of the prohibited medications or nondrug therapies from the Baseline Visit through 7 days after the first dose of study intervention. * The participant has been previously enrolled in this study or has previously been treated with gepotidacin. * The participant has participated in a clinical trial and has received an investigational product within 30 days or 5 half-lives, whichever is longer.

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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

    Modesto, California, 95350-5365, United States

  • GSK Investigational Site

    Pasadena, California, 91101-2453, United States

  • GSK Investigational Site

    San Diego, California, 92120-5259, United States

  • GSK Investigational Site

    Valencia, California, 91355, United States

  • GSK Investigational Site

    Miami, Florida, 33135, United States

  • GSK Investigational Site

    Ormond Beach, Florida, 32174-6302, United States

  • GSK Investigational Site

    Palm Springs, Florida, 33406-7671, United States

  • GSK Investigational Site

    Palm Springs, Florida, 33461, United States

  • GSK Investigational Site

    Plant City, Florida, 33563-4202, United States

  • GSK Investigational Site

    Sweetwater, Florida, 33172-2741, United States

  • GSK Investigational Site

    West Palm Beach, Florida, 33409-3401, United States

  • GSK Investigational Site

    West New York, New Jersey, 07093-2622, United States

  • GSK Investigational Site

    New York, New York, 10016-7313, United States

  • GSK Investigational Site

    Dayton, Ohio, 45424, United States

  • GSK Investigational Site

    Forney, Texas, 75126-4174, United States

  • GSK Investigational Site

    Houston, Texas, 77036, United States

  • GSK Investigational Site

    Houston, Texas, 77087, United States

  • GSK Investigational Site

    Kingwood, Texas, 26537, United States

  • GSK Investigational Site

    Mesquite, Texas, 75149, United States

  • GSK Investigational Site

    Missouri City, Texas, 77459-4756, United States

  • GSK Investigational Site

    Bountiful, Utah, 84010-4943, United States

  • GSK Investigational Site

    Morgantown, West Virginia, 26501, United States

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