Cluster RCT of Co-administration Azithromycin, Albendazole & Ivermectin

London School of Hygiene and Tropical Medicine

Status and phase: Completed; Phase 4

Conditions: Lymphatic Filariases; Trachoma

Treatments: Drug: Administration of Azithromycin on Day 15; Drug: Administration of Azithromycin on Day 1; Drug: Administration of Albendazole on Day 1; Drug: Administration of Ivermectin on Day 1

Study type: Interventional

Funder types: Other

Identifiers

NCT03570814

11985

Details and patient eligibility

About

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.

Enrollment: 13,511 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Residing in the community for at least three months;
2. Eligible to receive all three agents according to standard MDA criteria

Exclusion criteria

1. Not eligible to receive one or more drugs according to standard MDA criteria;

2. Less than 5 years of age (not eligible for ivermectin)**

3. Pregnant women (azithromycin only, not eligible for albendazole and ivermectin)

4. Lactating women (Only administered azithromycin and albendazole, not eligible for ivermectin)**

5. History of allergies to the drugs being studied (azithromycin, ivermectin, albendazole)

6. Residents who cannot swallow tablets

   • Note that patients that are not eligible for IVM, will receive azithromycin and albendazole. Patients that receive azithromycin and albendazole will be followed up through the same procedure as the triple drug therapy to try to track any AEs attributed to the two drug combination.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13,511 participants in 2 patient groups

Separate Administration

Active Comparator group

Description:

Standard administration of Albendazole/Ivermectin separated from administration of azithromycin

Treatment:

Drug: Administration of Ivermectin on Day 1

Drug: Administration of Azithromycin on Day 15

Drug: Administration of Albendazole on Day 1

Co-administration

Experimental group

Description:

Combined administration of Albendazole/Ivermectin/Azithromycin at a single time point

Treatment:

Drug: Administration of Ivermectin on Day 1

Drug: Administration of Azithromycin on Day 1

Drug: Administration of Albendazole on Day 1