Last Updated: 19/02/2019

Safety of the Co-administration of Azithromycin, Albendazole and Ivermectin Versus Standard Treatment Regimens During Mass Drug Administration (MDA) in Ethiopia: a Cluster-randomized Trial

Objectives

This study will compare the number of adverse events (AEs) and severe adverse events (SAEs) between the two arms to determine if co-administration of azithromycin, ivermectin and albendazole is not inferior to the standard treatment (current MDA treatment schedule beginning with Ivermectin/Albendazole followed two weeks later with azithromycin).

The primary outcome will be to demonstrate the safety of the triple-drug administration as measured by incidence of AEs/SAEs following the MDA.

*This study, even though is not directly related to malaria, will generate relevant data that can also inform the use of ivermectin for malaria transmission control.

Principal Institution

London School of Hygiene and Tropical Medicine (LSHTM), United Kingdom

Partner Institutions

Armauer Hansen Research Institute (AHRI), Ethiopia
Ministry of Health (MOH) Ethiopia

Rationale and Abstract

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.

Dose: Participants will receive Ivermectin 150mcg/kg (max 12mg)

Outcome measures:

Primary outcome: Self-reported adverse events (timeframe 1 month)
Secondary outcomes: Cost of administration of the drugs separately compared to the cost of co-administration of the drugs, community perceptions (analysis of community perceptions of benefits of co-administration at a single time point vs standard separated MDA will be conducted by conducting focus groups and in-depth interviews with study participants)

Study Design

ClinicalTrials.gov Identifier: NCT03570814

Study Type :	Interventional (Clinical Trial)
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Intervention Model Description:	Cluster randomised trial. Approximately 40 clusters per study arm
Masking:	None (Open Label)
Primary Purpose:	Treatment