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Urinary Tract InfectionsPhase 3SISNCT06597344

A Study in Adolescent and Adult Female Participants to Evaluate Clinical Symptom Improvement and the Safety of Gepotidacin During Treatment of Uncomplicated Urinary Tract Infections (Acute Cystitis)

A Phase 3 study testing Gepotidacin in people with Urinary Tract Infections, run by GlaxoSmithKline at 22 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The study will be conducted to evaluate the clinical symptom improvement and safety of oral gepotidacin for treatment of uncomplicated UTI (acute cystitis) in adolescent and adult female participants. Read more about this study

Who is it for?
Ages 12 years and older, women only
Conditions the study is for
Urinary Tract Infections
What is being tested?
Gepotidacin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
97 participants
Where
22 sitesUnited States
Study dates
2 Oct 2024to 10 Mar 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 32Show fewer
  • 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.

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

United States22 sites

  • GSK Investigational Site

    Bountiful, Utah, 84010-4943

  • GSK Investigational Site

    Dayton, Ohio, 45424

  • GSK Investigational Site

    Forney, Texas, 75126-4174

  • GSK Investigational Site

    Houston, Texas, 77036

  • GSK Investigational Site

    Houston, Texas, 77087

  • GSK Investigational Site

    Kingwood, Texas, 26537

  • GSK Investigational Site

    Mesquite, Texas, 75149

  • GSK Investigational Site

    Miami, Florida, 33135

  • GSK Investigational Site

    Missouri City, Texas, 77459-4756

  • GSK Investigational Site

    Modesto, California, 95350-5365

  • GSK Investigational Site

    Morgantown, West Virginia, 26501

  • GSK Investigational Site

    New York, New York, 10016-7313

  • GSK Investigational Site

    Ormond Beach, Florida, 32174-6302

  • GSK Investigational Site

    Palm Springs, Florida, 33406-7671

  • GSK Investigational Site

    Palm Springs, Florida, 33461

  • GSK Investigational Site

    Pasadena, California, 91101-2453

  • GSK Investigational Site

    Plant City, Florida, 33563-4202

  • GSK Investigational Site

    San Diego, California, 92120-5259

  • GSK Investigational Site

    Sweetwater, Florida, 33172-2741

  • GSK Investigational Site

    Valencia, California, 91355

  • GSK Investigational Site

    West New York, New Jersey, 07093-2622

  • GSK Investigational Site

    West Palm Beach, Florida, 33409-3401

Other trials in United States

About this study

Official title: A Phase 3b, Open-label, Single-arm Study in Adolescent and Adult Female Participants to Evaluate Clinical Symptom Improvement and the Safety of Gepotidacin During Treatment of Uncomplicated Urinary Tract Infections (Acute Cystitis)

The study will be conducted to evaluate the clinical symptom improvement and safety of oral gepotidacin for treatment of uncomplicated UTI (acute cystitis) in adolescent and adult female participants.

Being tested
Gepotidacin
Keywords
Gepotidacin, Uncomplicated Urinary Tract Infection, Acute Cystitis, Symptom Improvement Study (SIS)
Medical subject headings
Urinary Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GepotidacinDrug

    Gepotidacin will be administered.

Study groups in NCT06597344
Study groupRoleWhat they receive
GepotidacinExperimentalSingle Arm
Receives: Drug: Gepotidacin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Achieving Clinical Symptom Improvement at 24 Hours (±4 Hours)

    Clinical Symptom improvement is defined as a decrease from Baseline in CSS (Clinical Symptom Score) total score of at least 1 point at 24 hours (±4 hours), without the need for other systemic antimicrobials. CSS Score ranges from 0 to 12. Higher scores indicate a higher presence and severity of UTI symptoms.

    Measured: At 24 hours (h) (±4 h)

Secondary outcomes (3)

  1. Percentage of Participants Achieving Clinical Symptom Improvement

    Clinical Symptom improvement is defined as a decrease from Baseline in CSS total score of at least 1 point at each timepoint(i.e.,48 hours (±4 hours), 72 hours (±4 hours), and 96 hours (±4 hours)), without the need for other systemic antimicrobials. CSS Score ranges from 0 to 12. Higher scores indicate a higher presence and severity of UTI symptoms.

    Measured: At 48 hours (h) (±4 h), 72 hours (±4 h), 96 hours (±4 h)

  2. Percentage of Participants Achieving Clinical Symptom Resolution

    Clinical Symptom resolution is defined as a decrease from Baseline to a CSS total score of 0 at each timepoint(i.e., 24 hours (±4 hours), 48 hours (±4 hours), 72 hours (±4 hours), and 96 hours (±4 hours)) without the need for other systemic antimicrobials. CSS Score ranges from 0 to 12. Higher scores indicate a higher presence and severity of UTI symptoms.

    Measured: At 24 hours (±4 h), 48 hours (±4 h), 72 hours (±4 h), 96 hours (±4 h)

  3. Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and AE of Special Interest (AESIs)

    Adverse Event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose resulted in death,is life-threatening,required hospitalization or prolongation of existing hospitalization,resulted in disability/incapacity,is congenital anomaly/birth defect, other situations which involved medical or scientific judgment or was associated with liver injury and impaired liver function. SAEs are subset of AEs. AEs displayed are TEAEs defined as any AE with an onset date/time on or after treatment start date/time. AESIs include cardiovascular(CV) AEs, gastrointestinal(GI) AEs, clostridioides difficile-associated diarrhea (C. difficile AEs), Acetylcholinesterase Inhibition(AchE-I). AEs were coded using Medical Dictionary for Regulatory Activities (MedDRA). The AE data presented below is of frequency threshold-0%.

    Measured: Up to 159 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start2 Oct 2024
  3. Primary completion10 Mar 2025
  4. Study completion10 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
97 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06597344
Sponsor's protocol ID
219575
Acronym
SIS
Status last verified
Jan 2026
First submitted
3 Sep 2024
Last updated
11 Feb 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Publications

  • Ramirez M, Gupta K, Diaz-Reganon J, Banerjee R, Bablani J, Powell D, Hankinson A, Janmohamed S. Gepotidacin and Early Symptom Improvement in Uncomplicated Urinary Tract Infection: A Nonrandomized Clinical Trial. JAMA Netw Open. 2026 Sep 1;9(9):e2634116. doi: 10.1001/jamanetworkopen.2026.34116.

    PubMed 42809288

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Gepotidacin in people with Urinary Tract Infections, run by GlaxoSmithKline at 22 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Clinical Symptom Improvement at 24 Hours (±4 Hours) (time frame: At 24 hours (h) (±4 h)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06597344, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.

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