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

September 13, 2019 updated by: London School of Hygiene and Tropical Medicine

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

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

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

1291

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Malaita
      • Atoifi, Malaita, Solomon Islands
        • Atoifi Adventist Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Parallel Treatment
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.
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.
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.
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.
Other: Sequential Treatment

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.

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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impetigo Prevalence at 12 Months
Time Frame: Baseline and 12 months
Change in prevalence of impetigo between baseline and 12-months
Baseline and 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Michael Marks, London School of Hygiene and Tropical Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

February 5, 2018

Study Registration Dates

First Submitted

February 24, 2016

First Submitted That Met QC Criteria

May 13, 2016

First Posted (Estimate)

May 17, 2016

Study Record Updates

Last Update Posted (Actual)

September 17, 2019

Last Update Submitted That Met QC Criteria

September 13, 2019

Last Verified

September 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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