Scabies Clinical Trial
Official title:
A Cluster Randomised Trial of the Safety of Co-Administration of IDA (Ivermectin, Diethylcarbamazine and Albendazole) & Azithromycin for Integrated Treatment of Neglected Tropical Diseases
This is a cluster randomised trial evaluating the safety of co-administering Azithromycin
alongside the new IDA (Ivermectin, Diethylcarbamazine, Albendazole) combination treatment for
LF.
Treatment will be provided as a single dose Mass Drug Administration (MDA) to the whole
community. Communities will be randomised to receive either treatment with IDA and
Azithromycin on the same day or separately.
Active monitoring for adverse events will be conducted and the frequency of adverse events
compared between individuals receiving combined MDA or separate MDA.
Recent studies have shown that single-dose combination therapy with three antifilarial drugs
(Ivermectin [IVE] + DEC + ALB) called IDA is superior to current regimens used in LF
elimination and may help accelerate LF elimination. WHO guidelines have changed to recommend
IDA in countries endemic for LF outside sub-Saharan Africa like Papua New Guinea.
Additional benefits of IVE are its activity against scabies and Strongyloides. Treatment with
IVE has shown to reduce the high prevalence of scabies in a village and in randomized control
trials elsewhere in the Pacific. Of particular importance was the finding that IVE was highly
effective against Strongyloides with a >95% reduction in prevalence sustained for nine
months.
Increasingly, the desirability of linking LF programs with other public health initiatives
also based on MDA is being appreciated. The existing programmatic infrastructure developed
for LF campaign presents an attractive vehicle for a demonstration project of integration of
MDAs against multiple Neglected Tropical Diseases (NTDs). The macrolide antibiotic
azithromycin (AZI) has been demonstrated to be highly effective as MDA for yaws control and
AZI is a highly effective and well-tolerated antibiotic treatment for trachoma that is able
to clear ocular infection with a single oral dose and is well tolerated.
Currently LF/STH/Scabies/strongyloides and yaws/trachoma are treated separately. Integration
of these existing MDA programs has the potential to be highly cost-effective as a population
health intervention. Integration includes both the safe co-administration of medicines and
operational planning, and it is currently advocated by WHO.
;
| 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
|
||
| 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 | |
| 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 |
NCT05862701 -
Comparison of Topical 5% Permethrin and Topical 10% Sulfur in the Treatment of Scabies
|
Phase 1 | |
| Active, not recruiting |
NCT05500326 -
Ivermectin Therapy for Scabies Infection in Children Younger Than 5 Years of Age (ITCHY Study)
|
Phase 2 | |
| Recruiting |
NCT04814511 -
Escalated Therapy of Scabies With INFECTOSCAB 5% (Permethrin)
|
Phase 3 | |
| Completed |
NCT05362513 -
Comparative Study Between Topical Permethrin 5% and Oral Ivermectin for the Treatment of Scabies
|
Phase 1 | |
| Completed |
NCT03178942 -
Multiple-Site Study to Evaluate the Therapeutic Equivalence of Permethrin Cream, 5% in the Treatment of Scabies
|
Phase 3 | |
| Completed |
NCT05117528 -
Streptococcus Pyogenes Carriage Acquisition and Transmission Study
|