Azithromycin - Ivermectin Mass Drug Administration for Skin Disease (AIM-Skin)

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

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 Difference in the change in prevalence of impetigo between baseline and 12- months between the parallel and the sequential treatment arms. Secondary Outcomes Change in the proportion of swab samples from which S. pyogenes is cultured between baseline and follow-up in the two arms The proportion of samples from which a drug-resistant isolate of S.pyogenes is cultured in the two arms

Site 1- Parallel Treatment Arm Single dose azithromycin (for yaws) and Ivermectin/Permethrin (for scabies) will be offered on D1. A second dose of Ivermectin/Permethrin will be offered 7-14 days later.

Site 2- Serial Treatment Arm Ivermectin/Permethrin (for scabies) will be offered on D1 with a second dose of Ivermectin/Permethrin offered 7-14 days later.. Single dose azithromycin (for yaws) will be offered at the twelve month follow-up visit.

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.

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.

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.

Change in the percentage of swab samples from which S. pyogenes is cultured between baseline and 12 month follow-up in the two arms

The proportion of samples from which a drug-resistant isolate of S.pyogenes is cultured in the two arms

Inclusion Criteria: All community members are able to be included in the study. Exclusion Criteria: Allergy to any of the components of the allocated drug regimen

Marks M, Toloka H, Baker C, Kositz C, Asugeni J, Puiahi E, Asugeni R, Azzopardi K, Diau J, Kaldor JM, Romani L, Redman-MacLaren M, MacLaren D, Solomon AW, Mabey DCW, Steer AC. Randomized Trial of Community Treatment With Azithromycin and Ivermectin Mass Drug Administration for Control of Scabies and Impetigo. Clin Infect Dis. 2019 Mar 5;68(6):927-933. doi: 10.1093/cid/ciy574.