Azithromycin - Ivermectin Mass Drug Administration for Skin Disease

• Status: Completed
• Trial end date: 2018-02-05
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: London School of Hygiene and Tropical Medicine
• Collaborators: Atoifi Adventist Hospital, Solomon Islands; Kirby Institute; Murdoch Childrens Research Institute
• Treatments: Azithromycin; Ivermectin; Permethrin

Criteria

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