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

• ClinicalTrials.gov Identifier: NCT02775617
• Recruitment Status: Completed
• First Posted: May 17, 2016
• Results First Posted: September 13, 2019
• Last Update Posted: September 17, 2019
• Sponsor: London School of Hygiene and Tropical Medicine
• Collaborators: Atoifi Adventist Hospital, Solomon Islands; Kirby Institute; Murdoch Childrens Research Institute
• Information provided by (Responsible Party): London School of Hygiene and Tropical Medicine

Study Description

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

Condition or disease	Intervention/treatment	Phase
Scabies; Yaws; Impetigo	Drug: Ivermectin; Drug: Azithromycin; Drug: Permethrin	Phase 4

Study Design

• 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

Arms and Interventions

Arm	Intervention/treatment
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.	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.

Outcome Measures

Primary Outcome Measures :

1. Impetigo Prevalence at 12 Months [ Time Frame: Baseline and 12 months ]
   Change in prevalence of impetigo between baseline and 12-months

Secondary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Solomon Islands

Atoifi Adventist Hospital

Atoifi, Malaita, Solomon Islands

Sponsors and Collaborators

London School of Hygiene and Tropical Medicine

Atoifi Adventist Hospital, Solomon Islands

Kirby Institute

Murdoch Childrens Research Institute

Investigators

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

  Study Documents (Full-Text)

Documents provided by London School of Hygiene and Tropical Medicine:

Study Protocol and Statistical Analysis Plan  [PDF] February 17, 2016

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Marks M, Toloka H, Baker C, Kositz C, Asugeni J, Puiahi E, Asugeni R, Azzopardi K, Diau J, Kaldor JM, Romani L, Redman-MacLaren M, MacLaren D, Solomon AW, Mabey DCW, Steer AC. Randomized Trial of Community Treatment With Azithromycin and Ivermectin Mass Drug Administration for Control of Scabies and Impetigo. Clin Infect Dis. 2019 Mar 5;68(6):927-933. doi: 10.1093/cid/ciy574.

• Responsible Party: London School of Hygiene and Tropical Medicine
• ClinicalTrials.gov Identifier: NCT02775617
• Other Study ID Numbers: 35148A
• First Posted: May 17, 2016
• 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

Additional relevant MeSH terms:

Impetigo; Scabies; Mite Infestations; Ectoparasitic Infestations; Skin Diseases, Parasitic; Parasitic Diseases; Skin Diseases, Infectious; Skin Diseases; Staphylococcal Skin Infections; Staphylococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Streptococcal Infections; Skin Diseases, Bacterial; Infection; Ivermectin; Permethrin; Antiparasitic Agents; Anti-Infective Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action