A Study in Pediatric Participants Aged ≥2 to <12 Years With a Suspected or Confirmed Bacterial In… (NCT07371429) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Study in Pediatric Participants Aged ≥2 to <12 Years With a Suspected or Confirmed Bacterial Infection or Receiving Prophylaxis Antibiotics
20 participantsStarted 2026-04-29
Plain-language 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.
Who can participate
Age range
2 Years – 11 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 vi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
AUC from time zero to the time of the last quantifiable concentration (AUC[0-t]) of gepotidacin
Timeframe: Up to 24 hours post dose (Day 1)
2
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC[0-inf]) of gepotidacin
Timeframe: Up to 24 hours post dose (Day 1)
3
Maximum observed plasma concentration (Cmax) of gepotidacin
Timeframe: Up to 24 hours post dose (Day 1)
4
Apparent oral clearance (CL/F) of gepotidacin
Timeframe: Up to 24 hours post dose (Day 1)
5
Apparent volume of distribution (Vz/F) of gepotidacin