Azithromycin - Ivermectin Mass Drug Administration for Skin Disease

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

Conditions

• Scabies
• Yaws
• Impetigo

Interventions

DRUG

Ivermectin

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.

DRUG

Azithromycin

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.

DRUG

Permethrin

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.

Sponsors & Collaborators

• Atoifi Adventist Hospital, Solomon Islands

  collaborator UNKNOWN

• Kirby Institute

  collaborator OTHER_GOV

• Murdoch Childrens Research Institute

  collaborator OTHER

• London School of Hygiene and Tropical Medicine

  lead OTHER

Principal Investigators

• Michael Marks · London School of Hygiene and Tropical Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-07-31

Primary Completion

2017-08-31

Completion

2018-02-05

Countries

• Solomon Islands