A randomized, double-blind, placebo-controlled trial to assess the safety, pharmacokinetics, and efficacy of escalating doses of oral ivermectin in scabies infected children weighing 5 to less than 15 kilograms

Phase 2

• Conditions: skin infestation ,Scabies

• Registration Number: PACTR202107598843502
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-15
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 398

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified