Azithromycin - Ivermectin Mass Drug Administration for Skin Disease

Scabies Clinical Trial

— AIM-Skin  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02775617
• Other study ID #: 35148A
• Status: Completed
• Phase: Phase 4
• Start date: July 2016
• Est. completion date: February 5, 2018

Study information

• Verified date: September 2019
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1291
• Est. completion date: February 5, 2018
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Impetigo
• Scabies
• Yaws

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Solomon Islands	Atoifi Adventist Hospital	Atoifi	Malaita

Sponsors (4)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	Atoifi Adventist Hospital, Solomon Islands, Kirby Institute, Murdoch Childrens Research Institute

Country where clinical trial is conducted

Solomon Islands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impetigo Prevalence at 12 Months	Change in prevalence of impetigo between baseline and 12-months	Baseline and 12 months
Secondary	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
Secondary	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