NCT03570814

Cluster RCT of Co-administration Azithromycin, Albendazole & Ivermectin

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 13,511 (actual)
• Sponsor: London School of Hygiene and Tropical Medicine · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Trachoma
• Lymphatic Filariases

Interventions

Type	Name	Description
DRUG	Administration of Albendazole on Day 1	Participants will receive Albendazole 400mg on study day 1.
DRUG	Administration of Ivermectin on Day 1	Participants will receive Ivermectin 150mcg/kg (max 12mg) on study day 1. Doses of Ivermectin will be determined using a standard dosing pole.
DRUG	Administration of Azithromycin on Day 1	Participants will receive Azithromycin 20mg/kg (max 1gm) on study day 1. Doses of Azithromycin will be determined using a standard dosing pole.
DRUG	Administration of Azithromycin on Day 15	Participants will receive Azithromycin 20mg/kg (max 1gm) on study day 15. Doses of Azithromycin will be determined using a standard dosing pole.

Timeline

• Start date: 2021-12-01
• Primary completion: 2022-02-01
• Completion: 2022-02-01
• First posted: 2018-06-27
• Last updated: 2022-08-19

Locations

1 site across 1 country: Ethiopia