Azithromycin - Ivermectin Mass Drug Administration for Skin Disease

Study Overview
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Brief Summary
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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

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

Conditions
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Scabies, Yaws, Impetigo

Intervention / Treatment
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* Drug: Ivermectin
* Drug: Azithromycin
* Drug: Permethrin


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Parallel Treatment<br>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. | Drug: Ivermectin<br>* 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.<br>Drug: Azithromycin<br>* 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.<br>Drug: Permethrin<br>* 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.<br>|
| Other: Sequential Treatment<br>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. | Drug: Ivermectin<br>* 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.<br>Drug: Azithromycin<br>* 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.<br>Drug: Permethrin<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impetigo Prevalence at 12 Months | Change in prevalence of impetigo between baseline and 12-months | Baseline and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Group A Streptococcus at 12 Months | Change in the percentage of swab samples from which S. pyogenes is cultured between baseline and 12 month follow-up in the two arms | 12 Months | 
| Antimicrobial Resistance in Culture Isolates | The proportion of samples from which a drug-resistant isolate of S.pyogenes is cultured in the two arms | 12 Months |