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

London School of Hygiene and Tropical Medicine

Status and phase: Completed; Phase 4

Conditions: Yaws; Impetigo; Scabies

Treatments: Drug: Permethrin; Drug: Azithromycin; Drug: Ivermectin

Study type: Interventional

Funder types: Other

Identifiers

NCT02775617

35148A

Details and patient eligibility

About

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

Enrollment: 1,291 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,291 participants in 2 patient groups

Parallel Treatment

Other group

Description:

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.

Treatment:

Drug: Ivermectin

Drug: Permethrin

Drug: Azithromycin

Sequential Treatment

Other group

Description:

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.

Treatment:

Drug: Ivermectin

Drug: Permethrin

Drug: Azithromycin