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Completed

NCT Number: NCT02775617

Azithromycin - Ivermectin Mass Drug Administration for Skin Disease

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

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Key information

Conditions

Scabies Bacterial Infections Bacterial Infections and Mycoses Ectoparasitic Infestations Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Impetigo Infections Mite Infestations Parasitic Diseases Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin Diseases, Parasitic Skin and Connective Tissue Diseases Spirochaetales Infections Staphylococcal Infections Staphylococcal Skin Infections Streptococcal Infections Treponemal Infections Yaws

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Atoifi Adventist Hospital

Atoifi, Malaita Province, Solomon Islands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ivermectin

Drug

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

Drug

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

Drug

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.

Primary outcomes

  1. Impetigo Prevalence at 12 Months

    Time frame: Baseline and 12 months

    Change in prevalence of impetigo between baseline and 12-months

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

London School of Hygiene and Tropical Medicine

Other

Collaborators

  • Atoifi Adventist Hospital, Solomon Islands
  • Kirby Institute
  • Murdoch Childrens Research Institute

Registry information

Official study title

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

Acronym: AIM-Skin

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
May 17, 2016
Registry last updated
Sep 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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