Status:
COMPLETED
Ivermectin Safety in Small Children
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
Fundação Alfredo da Matta (FUAM)
Kenya Medical Research Institute
Conditions:
Scabies
Eligibility:
All Genders
2-5 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
Scabies is a skin infestation caused by a mite called Sarcoptes scabiei. Scabies is characterised by a rash and severe itching, which is an allergic reaction to the eggs and feces the females deposit ...
Eligibility Criteria
Inclusion
- 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
- 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 to the first dose of study medication until the completion of the follow-up procedure, unless in the opinion of investigator, the medication will not interfere with the study procedures or compromise patient safety; the investigator will take advice from the manufacturer representative as necessary.
- The investigator, health care provider or study staff feel that the patient is not suitable for study participation due to chronic illness, suspected underlying illness, or concerns that the patient will adhere to follow-up schedule.
- Previously treated in the ISSC study
Key Trial Info
Start Date :
November 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 4 2025
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT04332068
Start Date
November 18 2023
End Date
April 4 2025
Last Update
December 18 2025
Active Locations (3)
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1
Alfredo da Matta Tropical Dermatology Foundation (FUAM)
Manaus, Brazil
2
Kenya Medical Research Institute
Kisumu, Kenya
3
MRC Unit The Gambia
Banjul, The Gambia