Ivermectin Safety in Small Children (NCT04332068) | Clinical Trial Compass
CompletedPhase 2
Ivermectin Safety in Small Children
Brazil, Kenya, The Gambia240 participantsStarted 2023-11-18
Plain-language summary
This trial will evaluate the safety, pharmacokinetics, and efficacy of ivermectin in scabies infected children weighing 5 to less than 15kg. This will allow future efforts to expand the indication of ivermectin treatment to infants weighing 5 to less than 15kg to treat numerous NTDs, allowing this young age group equitable access to the numerous benefits of ivermectin therapy.
Who can participate
Age range2 Months – 5 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female child weighing 5 to \<15 kilograms
* ≥2 months old
* Scabies infestation
* Available to attend all study visits
* Parents/guardians/carers able to provide consent
Exclusion Criteria:
The participant may not enter the trial if ANY of the following apply:
* A history of renal or hepatic impairment.
* Any other significant disease or disorder (e.g. moderate or severe malnutrition) which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
* Participants who have participated in another research trial involving an investigational product in the past 12 weeks.
* Children with Crusted/Norwegian scabies or severe secondary bacterial infections (e.g. sepsis)
* Children who have taken ivermectin or topical permethrin cream within the last two weeks
* Children with known allergies to ivermectin or topical permethrin cream or excipients
* Loa loa infection risk, assessed based on travel history to endemic areas
* Use of prescription (especially CYP3A4 inhibitors or inducers) or non-prescription drugs (except paracetamol at doses of up to 90 milligrams/kg/day), including vitamins (especially vitamin C), herbal and dietary supplements (including St. John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 times the drug half-life (whichever is longer) prior t…
What they're measuring
1
Comparing the occurrence of adverse events between the intervention (ivermectin) and control (permethrin) groups