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A Study in Pediatric Participants Aged ≥2 to <12 Years With a Suspected or Confirmed Bacterial Infection or Receiving Prophylaxis Antibiotics | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE1

A Study in Pediatric Participants Aged ≥2 to <12 Years With a Suspected or Confirmed Bacterial Infection or Receiving Prophylaxis Antibiotics

Phase 1, Open-Label, Single Arm (Non-comparator) Study to Evaluate the Pharmacokinetics and Safety of a Single Dose of Oral Gepotidacin in Addition to Antibacterial Standard of Care in Pediatric Participants From 2 to Less Than 12 Years of Age With a Suspected or Confirmed Bacterial Infection or Receiving Prophylaxis With Antibiotics

NCT07371429•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

The study will be conducted to evaluate how a single oral dose of Gepotidacin is processed in the body over time along with safety monitoring in hospitalized pediatric participants who are receiving a standard of care treatment with antibacterials for a confirmed or suspected infection or for its prevention.

Eligibility

Age

2 - 11 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants having ≥2 to \<12 years of age at the time of signing the informed consent/assent and have a body weight \>=10 kilograms (kg).
•Participants receiving SoC antibacterial therapy for a confirmed/suspected infection or for prophylaxis AND is able to take a single dose of the powder for oral suspension formulation of gepotidacin after a meal.
•Participants either hospitalized or in an overnight clinic. Participant is expected to be in hospital/clinic for at least 24 hours post administration of study intervention.
•Participant has an indwelling venous catheter in place as part of the clinical SoC.
•Male or female according to their reproductive organs at birth.
•Pregnancy testing is required as appropriate for the age, sexual activity, and sexual maturity of pediatric participants and as required by local regulations. Investigator should apply clinical judgment.
•A female participant is eligible to participate if she is a WOCBP who is not pregnant as confirmed by a high sensitivity serum or urine pregnancy test at baseline (Day 1) regardless of current or prior contraception use or abstinence, is not breastfeeding, or is not a WOCBP.
•Participant LAR(s) who has the ability to understand, agree to, and sign the informed consent form before initiation of any protocol-related procedures; participant has the ability to give documented assent.
•Participant and participant's LAR are willing and able to comply with study instructions, study visits, and procedures.

Exclusion Criteria

•Participants having a BMI-for-age that is less than the 5th percentile or greater than the 95th percentile based on the CDC percentiles \[CDC NCHS Growth Charts\].
•Participants having a clinically significant medical history, including malignancy, significant chromosome abnormality, neurological disorder or history of seizure (excluding simple febrile seizure), chronic immunosuppressive disease, active tuberculosis or acute hepatitis.
•Participants with serious disease/condition that could be imminently life-threatening (e.g. is clinically/hemodynamically unstable, is septicemic, has severe sepsis, organ failure, requiring ITU care or has clinical laboratory tests either nonstable or anticipated to be nonstable) or the participant is unlikely to survive for the duration of the study period.
•The participant has severe renal organ dysfunction or has known anuria, oliguria, or significant impairment of renal function (creatinine clearance \<60 mL/min or clinically significant elevated serum creatinine as determined by the investigator).
•The participant has a significant CV history or based on investigator judgment any clinically significant abnormal ECG reading at Screening/baseline (e.g., prolonged QT syndrome).
•The participant has congenital anomalies of the GI tract, heart or liver, including GI tract abnormalities (obstruction, atresia) and Gl tract immaturity.
•The participant has a history of sensitivity to the study intervention, or components thereof, or a history of a drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates study participation.
•The participant is immunocompromised or has altered immune defenses that may predispose the participant to a higher risk of complications (e.g., uncontrolled diabetes in the judgment of the investigator, transplant recipients (with the exception of cornea and autologous BMT), participants with clinically significant persistent granulocytopenia \[absolute neutrophil count \<1000/μL\], and participants receiving immunosuppressive therapy, including corticosteroid therapy \[\>20 mg/day prednisolone or equivalent for \>1 week, 20 mg/day prednisolone or equivalent for \>2 weeks, or prednisolone or equivalent ≥10 mg/day for \>6 weeks\]). Participants with a known CD4 count of \<200 cells/mm3 are to not be enrolled.
•The participant has any of the following medical condition that requires medication that may be impacted by inhibition of acetylcholinesterase, such as:
•* Poorly controlled asthma or obstructive pulmonary disease at baseline and, in the opinion of the investigator, not stable on current therapy.
+24 more criteria

Key Dates

Start Date

March 31, 2026

Primary Completion Date

August 23, 2027

Completion Date

August 23, 2027

Last Updated

February 12, 2026

Enrollment

ESTIMATED participants

Conditions

Urinary Tract Infections

Interventions

Gepotidacin

DRUG

SOC

DRUG

Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study in Pediatric Participants Aged ≥2 to <12 Years With a Suspected or Confirmed Bacterial Infection or Receiving Prophylaxis Antibiotics

Inclusion Criteria

Exclusion Criteria

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