Scabies Clinical Trial
Official title:
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
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
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02572986 -
A Study to Evaluate the Therapeutic Equivalence of Generic Permethrin Cream 5% to Elimite® in the Treatment of Scabies
|
Phase 3 | |
| Completed |
NCT00884728 -
Evaluation of a Regional Healthy Skin Program in Remote Aboriginal Communities of Australia's Northern Territory
|
N/A | |
| Completed |
NCT05025696 -
Efficacy and Side Effects of Blacksoap® as Adjuvant Therapy of Scabies
|
N/A | |
| Completed |
NCT04205669 -
Comparing the Effectiveness of Individual vs. Household Treatment for Scabies in Lambaréné, Gabon
|
Phase 4 | |
| Completed |
NCT02254564 -
PCR (Polymerase Chain Reaction) Assay for Diagnosis of Sarcoptes Scabiei
|
||
| Not yet recruiting |
NCT06404333 -
Evaluating Pediatric Ivermectin in Children Under 15 kg (EPIC-15)
|
Phase 2 | |
| Completed |
NCT03676140 -
Safety of Co-administration of IDA and Azithromycin for NTDs ( ComboNTDs )
|
Phase 3 | |
| Recruiting |
NCT05875441 -
Efficacy and Safety Study of Moxidectin in Adults With Scabies
|
Phase 2 | |
| Completed |
NCT02978508 -
Bio-equivalence Study Comparing Permethrin Cream, 5% With Elimite in Patients With Active Scabies.
|
Phase 3 | |
| Recruiting |
NCT04332068 -
Ivermectin Safety in Small Children
|
Phase 2 | |
| Recruiting |
NCT04844905 -
Adjunctive Ivermectin Mass Drug Administration for Malaria Control
|
Phase 3 | |
| Not yet recruiting |
NCT06380452 -
Therapy for Scabies With Two Differently Concentrated Permethrin Creams
|
Phase 3 | |
| Completed |
NCT00604084 -
Veron Scabies Education and Eradication Program
|
N/A | |
| Completed |
NCT02485717 -
Phase 3 Trial to Assess the Safety and Efficacy of Natroba for the Treatment of Scabies
|
Phase 3 | |
| Completed |
NCT02485704 -
Phase 3 Trial to Assess the Safety and Efficacy of Natroba for the Treatment of Scabies
|
Phase 3 | |
| Recruiting |
NCT05310734 -
PK and Safety Study of Natroba Topical Suspension 0.9% in Subjects 1 Month to 3 Years 11 Months of Age With Scabies
|
Phase 4 | |
| Recruiting |
NCT04931680 -
Risk Factors for Treatment Failure of Scabies in Autochthonous Populations of French Guiana (GUYAGALE)
|
||
| Completed |
NCT06396507 -
Sulfur vs. Different Regimes of Permethrin for Scabies
|
Phase 3 | |
| Completed |
NCT05862701 -
Comparison of Topical 5% Permethrin and Topical 10% Sulfur in the Treatment of Scabies
|
Phase 1 | |
| Not yet recruiting |
NCT05500326 -
Ivermectin Therapy for Scabies Infection in Children Younger Than 5 Years of Age (ITCHY Study)
|
Phase 2 |