A Study in Pediatric Participants Aged ≥2 to <12 Years With a Suspected or Confirmed Bacterial Infection or Receiving Prophylaxis Antibiotics
NCT07371429 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-04-23
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
Interventions
- DRUG
-
Gepotidacin
Gepotidacin will be administered
- DRUG
-
SOC
SOC will be administered
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 2 Years
- Max Age
- 11 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-29
- Primary Completion
- 2027-08-23
- Completion
- 2027-08-23
- FDA Drug
- Yes
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