Azithromycin - Ivermectin Mass Drug Administration for Skin Disease

NCT02775617 | Completed Phase 4 Results

• 1 other identifier: 35148A
• Study Type: interventional
• Target: 1,291
• Locations: 1 country
• Sites: 1

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. 1.Difference in the change in prevalence of impetigo between baseline and 12- months between the parallel and the sequential treatment arms.
2. 2.Change in the proportion of swab samples from which S. pyogenes is cultured between baseline and follow-up in the two arms
3. 3.The proportion of samples from which a drug-resistant isolate of S.pyogenes is cultured in the two arms

Conditions

Scabies; Yaws; Impetigo

Outcome Measures

Primary Outcomes (1)

• Impetigo Prevalence at 12 Months

  Change in prevalence of impetigo between baseline and 12-months

  Baseline and 12 months

Secondary Outcomes (2)

• Group A Streptococcus at 12 Months

  12 Months

• Antimicrobial Resistance in Culture Isolates

  12 Months

Study Arms (2)

Parallel Treatment

OTHER

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; Drug: Azithromycin; Drug: Permethrin

Sequential Treatment

OTHER

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; Drug: Azithromycin; Drug: Permethrin

Interventions

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.

Parallel Treatment; Sequential Treatment

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.

Parallel Treatment; Sequential Treatment

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.

Parallel Treatment; Sequential Treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All community members are able to be included in the study.

You may not qualify if:

• Allergy to any of the components of the allocated drug regimen

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Atoifi Adventist Hospital, Solomon Islands: collaborator
• Kirby Institute: collaborator
• Murdoch Childrens Research Institute: collaborator

Study Sites (1)

Atoifi Adventist Hospital

Atoifi, Malaita Province, Solomon Islands

Location

Related Publications (1)

• 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.

  PMID: 29985978 DERIVED

MeSH Terms

Conditions

Scabies; Yaws; Impetigo

Interventions

Ivermectin; Azithromycin; Permethrin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals; Erythromycin; Phenyl Ethers; Ethers; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pyrethrins; Cyclopentane Monoterpenes; Monoterpenes; Terpenes

Results Point of Contact

• Title: Dr Michael Marks
• Organization: London School of Hygiene and Tropical Medicine

michael.marks@lshtm.ac.uk

02079272566

Study Officials

• Michael Marks

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2016
• First Posted: May 17, 2016
• Study Start: July 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: February 5, 2018
• Last Updated: September 17, 2019
• Results First Posted: September 13, 2019

Record last verified: 2019-09

Locations

SO (1)