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.
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