Cluster RCT of Co-administration Azithromycin, Albendazole & Ivermectin
Status:
Not yet recruiting
Trial end date:
2022-07-01
Target enrollment:
Participant gender:
Summary
Cluster-randomised trial comparing co-administration of Azithromycin/Ivermectin/Albendazole
with separate administration of Azithromycin and Ivermectin/Albendazole.
The study will be conducted in Beneshangul-Gumuz region, Ethiopia. Within this district, a
study group of 8,000 people (in approximately 40 clusters) will receive the azithromycin,
ivermectin & albendazole at a single time. A control group of 8,000 people (in approximately
40 clusters) within the same district will receive the current MDA treatment schedule
beginning with Ivermectin/Albendazole followed two weeks later with azithromycin. All drug
dosing will be in line with standard FMOH and WHO Guidelines for MDA for trachoma and
lymphatic filariasis.
The study will randomly sort subdistrict communities (Gotes) into the trial arm and the
control arm. The study will compare the number of adverse events (AEs) and severe adverse
events (SAEs) between the two arms to determine if co-administration is not inferior to the
standard treatment. The primary outcome will be to demonstrate the safety of the triple-drug
administration as measured by incidence of AEs/SAEs following the MDA.
Phase:
Phase 4
Details
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Collaborators:
Armauer Hansen Research Institute, Ethiopia Federal Ministry of Health, Ethiopia Federal Minstry of Health of Ethiopia