Cluster RCT of Co-administration Azithromycin, Albendazole & Ivermectin

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.

Timeline

Start

2021-12-01

Primary completion

2022-02-01

Completion

2022-02-01

Publications

• McPherson S, Tafese G, Tafese T, Behaksra SW, Solomon H, Oljira B, Miecha H, Debebe KA, Kebede B, Gebre T, Kebede F, Seife F, Tadesse F, Mammo B, Aseffa A, Solomon AW, Mabey DCW, Marks M, Gadisa E. Safety of integrated mass drug administration of azithromycin, albendazole and ivermectin versus standard treatment regimens: a cluster-randomised trial in Ethiopia. EClinicalMedicine. 2023 Apr 27;59:101984. doi: 10.1016/j.eclinm.2023.101984. eCollection 2023 May.

Drugs

Indications