A Phase 4 interventional study of Ivermectin and Azithromycin in Scabies, Yaws and Impetigo, sponsored by London School of Hygiene and Tropical Medicine. Completed at 1 site in Solomon Islands. Per ClinicalTrials.gov, last updated 2019-09-17.
Sponsored by London School of Hygiene and Tropical Medicine · Phase 4, Interventional, and Treatment
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
51 studies on the registry are indexed under Scabies; 10 are open to participants now.
This study's enrollment of 1,291 is above the median of 183 across 41 interventional studies indexed under Scabies.
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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
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
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.
Impetigo Prevalence at 12 Months
Change in prevalence of impetigo between baseline and 12-months
Time frame: Baseline and 12 months
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
Time frame: 12 Months
Antimicrobial Resistance in Culture Isolates
The proportion of samples from which a drug-resistant isolate of S.pyogenes is cultured in the two arms
Time frame: 12 Months
| Milestone | Parallel Treatment | Sequential Treatment |
|---|---|---|
| Started | 653 | 638 |
| Completed | 605 | 478 |
| Not completed | 48 | 160 |
Change in prevalence of impetigo between baseline and 12-months
| Cases of impetigo | Parallel Treatment | Sequential Treatment |
|---|---|---|
| Cases Impetigo at Baseline | 79 | 66 |
| Cases Impetigo at 12 Months | 20 | 12 |
Change in the percentage of swab samples from which S. pyogenes is cultured between baseline and 12 month follow-up in the two arms
| Change in number swabs with S.pyogenes | Parallel Treatment | Sequential Treatment |
|---|---|---|
| Swabs containing S.pyogenes at baseline | 17 | 28 |
| Swabs containing S.pyogenes at 12 months | 4 | 1 |
The proportion of samples from which a drug-resistant isolate of S.pyogenes is cultured in the two arms
| Number of swabs | Parallel Treatment | Sequential Treatment |
|---|---|---|
| % Swabs with resistance at baseline | 0 | 0 |
| % Swabs with resistance at 12 months | 0 | 0 |
Collected over 1 year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Parallel Treatment | 0/653 (0%) | 0/653 (0%) | 0/653 (0%) |
| Sequential Treatment | 0/638 (0%) | 0/638 (0%) | 0/638 (0%) |
| Age, Continuous(years) | Parallel Treatment | Sequential Treatment | Total |
|---|---|---|---|
| Median | 24 (10 to 45) | 25 (12 to 47) | 25 (10 to 47) |
| Sex: Female, Male(Participants) | Parallel Treatment | Sequential Treatment | Total |
|---|---|---|---|
| Female | 335 | 312 | 647 |
| Male | 318 | 326 | 644 |
| Race (NIH/OMB)(Participants) | Parallel Treatment | Sequential Treatment | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 653 | 638 | 1291 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Parallel Treatment | Sequential Treatment | Total |
|---|---|---|---|
| Solomon Islands | 653 | 638 | 1291 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — Anonymised data may be made available
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Ivermectin · Azithromycin
London School of Hygiene and Tropical Medicine →