CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,291 enrolled
Drug / intervention
Ivermectin +2 moredrug
Likely dose
Ivermectin 200μgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02775617
NCT02775617Phase 4Completed

Impact of Combined Azithromycin and Ivermectin Mass Drug Administration for Yaws and Scabies - Impact on Impetigo and Skin Microbiology

London School of Hygiene and Tropical Medicine·interventional·Posted May 17, 2016·Updated Sep 17, 2019

In Brief

A Phase 4 clinical trial evaluating Ivermectin, Azithromycin, and 1 other intervention for Scabies and 2 related conditions. Completed, enrolled 1,291 participants across 1 site.

Detailed Summary

This is an open-label prospective community intervention trial to assess the impact of community mass treatment with azithromycin for yaws and ivermectin for scabies, on non-yaws bacterial skin infections. Communities will be randomised to receive standard treatment for both yaws and scabies either in parallel (site 1) or in sequence (site 2). Treatment of yaws: Single dose of Azithromycin (30mg/kg, max 2G). Treatment of scabies: Either an oral dose of Ivermectin (200μg/kg) or permethrin cream for those with a contraindication to Ivermectin (WT\<15kg, pregnant or breastfeeding women) given in 2 doses 7-14 days apart. Investigators will complete a clinical and microbiological assessment of bacterial skin disease at baseline and at 12 months to assess the impact of treatment on the prevalence of bacterial infection and the emergence of antimicrobial resistance. Primary Outcome 1. Difference in the change in prevalence of impetigo between baseline and 12- months between the parallel and the sequential treatment arms. Secondary Outcomes 2. Change in the proportion of swab samples from which S. pyogenes is cultured between baseline and follow-up in the two arms 3. The proportion of samples from which a drug-resistant isolate of S.pyogenes is cultured in the two arms

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsScabies, Yaws, Impetigo
CountriesSolomon Islands

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 17, 2016
Enrollment StartJul 1, 2016
Primary CompletionAug 1, 2017
Study CompletionFeb 5, 2018
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 10.1 years ago

Interventions

Ivermectindrug

Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Ivermectin will be offered as a a single dose 200μg/kg on Day 1 and Day 8.

Azithromycindrug

Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Azithromycin will be offered as single dose of 30mg/kg, max 2G.

Permethrindrug

Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Individuals with a contra-indication to ivermectin will be offered Permethrin instead.