Azithromycin - Ivermectin Mass Drug Administration for Skin Disease

Phase 4

Completed

Conditions: Yaws
Impetigo
Scabies

Interventions: Drug: Ivermectin
Drug: Azithromycin
Drug: Permethrin

Registration Number: NCT02775617

Lead Sponsor: London School of Hygiene and Tropical Medicine

Brief 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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1291

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sequential Treatment	Azithromycin	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.
Sequential Treatment	Ivermectin	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.
Parallel Treatment	Ivermectin	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.
Parallel Treatment	Azithromycin	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.
Parallel Treatment	Permethrin	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.
Sequential Treatment	Permethrin	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.

Primary Outcome Measures

Name	Time	Method
Impetigo Prevalence at 12 Months	Baseline and 12 months	Change in prevalence of impetigo between baseline and 12-months

Secondary Outcome Measures

Name	Time	Method
Antimicrobial Resistance in Culture Isolates	12 Months	The proportion of samples from which a drug-resistant isolate of S.pyogenes is cultured in the two arms
Group A Streptococcus at 12 Months	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