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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

StatusNot Yet Recruiting
PhasePhase 1
Started
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Record History

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  1. Start date: Apr 29, 2026 to Sep 18, 2026 Show 4 more changesShow less
    • Primary endpoints: details revised at 3 of 6 entries
    • Enrollment increased: 20 → 25 participants
    • Trial sites expanded: 0 → 4 locations
    • Eligibility criteria expanded, about 4 words
  2. Start date: Mar 31, 2026 to Apr 29, 2026
    • Eligibility criteria shortened, about 45 words
    v3
  3. Re-verified, no change to tracked fieldsv2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
GlaxoSmithKline
246 trials monitored
See 20 trials at risk
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.
Trial Details
NCT Number NCT07371429
Lead Sponsor GlaxoSmithKline
Conditions
(from sponsor)		 Urinary Tract Infections
Related terms Bacterial Infections, Urinary Tract Infections
Enrollment 25 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov