Gepotidacin for Urinary Tract Infections in Children
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for children aged 2 to under 12 years, weighing at least 10 kg, who are hospitalized and receiving antibiotics for a suspected or confirmed bacterial infection (like urinary tract or skin infections) or as prevention. They must be able to take an oral dose of the study drug and stay in the hospital/clinic for at least 24 hours.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Gepotidacin
Trial Overview
The study tests how a single oral dose of gepotidacin is processed in children's bodies compared to standard antibiotic care. All participants receive their usual antibiotics; some also get one dose of gepotidacin. The focus is on safety and how the body handles the new drug.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Single Arm
Find a Clinic Near You
Who Is Running the Clinical Trial?
GlaxoSmithKline
Lead Sponsor
Dame Emma Walmsley
GlaxoSmithKline
Chief Executive Officer since 2017
MA in Classics and Modern Languages from Oxford University
Dr. Hal Barron
GlaxoSmithKline
Chief Medical Officer since 2018
MD from Harvard Medical School
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