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

NCT07371429 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: 2227782025-522916-17
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Urinary Tract Infections

Keywords

Gepotidacin; Antibacterial Standard of Care; Antibiotics; Bacterial Infection; Urinary Tract Infections

Outcome Measures

Primary Outcomes (6)

• AUC from time zero to the time of the last quantifiable concentration (AUC[0-t]) of gepotidacin

  Up to 24 hours post dose (Day 1)

• Area under the concentration-time curve from time zero extrapolated to infinite time (AUC[0-inf]) of gepotidacin

  Up to 24 hours post dose (Day 1)

• Maximum observed plasma concentration (Cmax) of gepotidacin

  Up to 24 hours post dose (Day 1)

• Apparent oral clearance (CL/F) of gepotidacin

  Up to 24 hours post dose (Day 1)

• Apparent volume of distribution (Vz/F) of gepotidacin

  Up to 24 hours post dose (Day 1)

• Terminal phase half-life (t1/2) of gepotidacin

  Up to 24 hours post dose (Day 1)

Secondary Outcomes (5)

• Number of participants with Adverse events (AEs), Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs)

  Up to 7 days (±3 days)

• Change from baseline in vital signs: Temperature

  At 2 hours (±15 mins) post dose on Day 1

• Change from baseline in vital signs: Blood Pressure

  At 2 hours (±15 mins) post dose on Day 1

• Change from baseline in vital signs: Pulse Rate

  At 2 hours (±15 mins) post dose on Day 1

• Change from baseline in Electrocardiogram (ECG)

  At 2 hours (±15 mins) post dose on Day 1

Study Arms (1)

Gepotidacin plus Standard of care (SOC)

EXPERIMENTAL

Single Arm

Drug: Gepotidacin; Drug: SOC

Interventions

Gepotidacin DRUG

Gepotidacin will be administered

Gepotidacin plus Standard of care (SOC)

SOC DRUG

SOC will be administered

Gepotidacin plus Standard of care (SOC)

Eligibility Criteria

• Age: 2 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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 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 at a dose of \>1 mg/kg/day of prednisolone or equivalent for \>1 week or 0.5-\<1 mg/kg/day prednisolone or equivalent for \>2 weeks). Participants aged ≥6 years with a known CD4 count of \<200 cells/mm3 and participants aged \<6 years with a known CD4 count of \<500 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.
• Active peptic ulcer disease
• Juvenile Parkinson disease
• Juvenile Myasthenia gravis
• The participant has any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion of the study intervention (e.g., ileostomy or malabsorption syndrome).
• The participant plans to use any of the prohibited medications or nondrug therapies from the Baseline Visit through Follow-up Visit at 7 ±3 days after the single dose of study intervention.
• The participant has received a prohibited medication within 14 days or 5 half-lives prior to gepotidacin administration, whichever is longer.
• The participant has been previously enrolled in this study or has previously been treated with gepotidacin.

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Urinary Tract Infections; Bacterial Infections

Interventions

gepotidacin

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Bacterial Infections and Mycoses

Central Study 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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: January 28, 2026
• Study Start: April 29, 2026
• Primary Completion (Estimated): August 23, 2027
• Study Completion (Estimated): August 23, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.