Azithromycin - Ivermectin Mass Drug Administration for Skin Disease (AIM-Skin)
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ClinicalTrials.gov Identifier: NCT02775617 |
Recruitment Status :
Completed
First Posted : May 17, 2016
Results First Posted : September 13, 2019
Last Update Posted : September 17, 2019
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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
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Difference in the change in prevalence of impetigo between baseline and 12- months between the parallel and the sequential treatment arms.
Secondary Outcomes
- Change in the proportion of swab samples from which S. pyogenes is cultured between baseline and follow-up in the two arms
- The proportion of samples from which a drug-resistant isolate of S.pyogenes is cultured in the two arms
Condition or disease | Intervention/treatment | Phase |
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Scabies Yaws Impetigo | Drug: Ivermectin Drug: Azithromycin Drug: Permethrin | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1291 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Impact of Combined Azithromycin and Ivermectin Mass Drug Administration for Yaws and Scabies - Impact on Impetigo and Skin Microbiology |
Actual Study Start Date : | July 2016 |
Actual Primary Completion Date : | August 2017 |
Actual Study Completion Date : | February 5, 2018 |

Arm | Intervention/treatment |
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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.
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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. |
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. |
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. |
- Impetigo Prevalence at 12 Months [ Time Frame: Baseline and 12 months ]Change in prevalence of impetigo between baseline and 12-months
- 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
- 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

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02775617
Solomon Islands | |
Atoifi Adventist Hospital | |
Atoifi, Malaita, Solomon Islands |
Principal Investigator: | Michael Marks | London School of Hygiene and Tropical Medicine |
Documents provided by London School of Hygiene and Tropical Medicine:
Responsible Party: | London School of Hygiene and Tropical Medicine |
ClinicalTrials.gov Identifier: | NCT02775617 |
Other Study ID Numbers: |
35148A |
First Posted: | May 17, 2016 Key Record Dates |
Results First Posted: | September 13, 2019 |
Last Update Posted: | September 17, 2019 |
Last Verified: | September 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | Anonymised data may be made available |
Impetigo Scabies Staphylococcal Skin Infections Staphylococcal Infections Gram-Positive Bacterial Infections Bacterial Infections Streptococcal Infections Skin Diseases, Bacterial Skin Diseases, Infectious Infection Skin Diseases Mite Infestations |
Ectoparasitic Infestations Skin Diseases, Parasitic Parasitic Diseases Azithromycin Ivermectin Permethrin Anti-Bacterial Agents Anti-Infective Agents Antiparasitic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |