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.
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.
Male or female according to their reproductive organs at birth.
Participants having a BMI-for-age that is less than the 5th percentile or greater than the 95th percentile based on the CDC percentiles [CDC NCHS Growth Charts].
Participants having a clinically significant medical history, including malignancy, significant chromosome abnormality, neurological disorder or history of seizure (excluding simple febrile seizure), chronic immunosuppressive disease, active tuberculosis or acute hepatitis.
Participants with serious disease/condition that could be imminently life-threatening (e.g. is clinically/hemodynamically unstable, is septicemic, has severe sepsis, organ failure, requiring ITU care or has clinical laboratory tests either nonstable or anticipated to be nonstable) or the participant is unlikely to survive for the duration of the study period.
The participant has severe renal organ dysfunction or has known anuria, oliguria, or significant impairment of renal function (creatinine clearance <60 mL/min or clinically significant elevated serum creatinine as determined by the investigator).
Single group
Gepotidacin
DrugGepotidacin will be administered
SOC
DrugSOC will be administered
AUC from time zero to the time of the last quantifiable concentration (AUC[0-t]) of gepotidacin
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC[0-inf]) of gepotidacin
Maximum observed plasma concentration (Cmax) of gepotidacin
Apparent oral clearance (CL/F) of gepotidacin
Number of participants with Adverse events (AEs), Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs)
Change from baseline in vital signs: Temperature
Change from baseline in vital signs: Blood Pressure
Change from baseline in vital signs: Pulse Rate
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