Ivermectin Safety in Small Children

• Status: Not yet recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oxford
• Collaborators: Chittagong Medical College; Kenya Medical Research Institute; Manhiça Health Research Centre (CISM); The Fundação de Medicina Tropical Doutor Heitor Vieira Dourado (FMT-HVD)
• Treatments: Ivermectin; Permethrin

Criteria

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 month

• 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.

• Not previously enrolled into this study