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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02775617
Other study ID # 35148A
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date July 2016
Est. completion date February 5, 2018

Study information

Verified date September 2019
Source London School of Hygiene and Tropical Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 1291
Est. completion date February 5, 2018
Est. primary completion date August 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.
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.

Locations

Country Name City State
Solomon Islands Atoifi Adventist Hospital Atoifi Malaita

Sponsors (4)

Lead Sponsor Collaborator
London School of Hygiene and Tropical Medicine Atoifi Adventist Hospital, Solomon Islands, Kirby Institute, Murdoch Childrens Research Institute

Country where clinical trial is conducted

Solomon Islands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Impetigo Prevalence at 12 Months Change in prevalence of impetigo between baseline and 12-months Baseline and 12 months
Secondary Group A Streptococcus at 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
Secondary Antimicrobial Resistance in Culture Isolates The proportion of samples from which a drug-resistant isolate of S.pyogenes is cultured in the two arms 12 Months
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