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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
Sponsor:
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
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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
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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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
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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
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Information from the National Library of Medicine

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


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

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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
Additional relevant MeSH terms:
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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