NCT07371429

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 2 Years – 11 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Gepotidacin	Gepotidacin will be administered
DRUG	SOC	SOC will be administered

Timeline

• Start date: 2026-03-31
• Primary completion: 2027-08-23
• Completion: 2027-08-23
• First posted: 2026-01-28
• Last updated: 2026-02-12

Regulatory

• FDA-regulated drug study