- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02775617
Azithromycin - Ivermectin Mass Drug Administration for Skin Disease (AIM-Skin)
Impact of Combined Azithromycin and Ivermectin Mass Drug Administration for Yaws and Scabies - Impact on Impetigo and Skin Microbiology
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
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
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Malaita
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Atoifi, Malaita, Solomon Islands
- Atoifi Adventist Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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.
|
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.
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.
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.
|
Other: 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. |
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.
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Impetigo Prevalence at 12 Months
Time Frame: Baseline and 12 months
|
Change in prevalence of impetigo between baseline and 12-months
|
Baseline and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 Months
|
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
|
12 Months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Michael Marks, London School of Hygiene and Tropical Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Streptococcal Infections
- Gram-Positive Bacterial Infections
- Parasitic Diseases
- Ectoparasitic Infestations
- Skin Diseases, Parasitic
- Skin Diseases, Infectious
- Staphylococcal Infections
- Skin Diseases, Bacterial
- Mite Infestations
- Staphylococcal Skin Infections
- Scabies
- Impetigo
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- Antiparasitic Agents
- Permethrin
- Azithromycin
- Ivermectin
Other Study ID Numbers
- 35148A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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