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
1 other identifier
interventional
13,511
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2021
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2018
CompletedFirst Posted
Study publicly available on registry
June 27, 2018
CompletedStudy Start
First participant enrolled
December 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2022
CompletedAugust 19, 2022
April 1, 2022
2 months
June 4, 2018
August 18, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Self Reported Adverse Event
The incidence of self-reported adverse events following MDA. We will collect data on the presence of common symptoms/signs prior to drug administration. All patients will be reviewed 24-48 hours after treatment and asked to report adverse events. We will calculate the proportion of newly occurring adverse events following treatment and calculate the whether the proportion of patients experiencing an adverse event differs between study arms,
1 Month
Secondary Outcomes (2)
Cost of Administration Drug Separately compared to Cost of Co-Administration of Drugs
1 month
Community perceptions
1 month
Study Arms (2)
Separate Administration
ACTIVE COMPARATORStandard administration of Albendazole/Ivermectin separated from administration of azithromycin
Co-administration
EXPERIMENTALCombined administration of Albendazole/Ivermectin/Azithromycin at a single time point
Interventions
Participants will receive Albendazole 400mg on study 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.
Participants will receive Azithromycin 20mg/kg (max 1gm) on study day 1. Doses of Azithromycin will be determined using a standard dosing pole.
Participants will receive Azithromycin 20mg/kg (max 1gm) on study day 15. Doses of Azithromycin will be determined using a standard dosing pole.
Eligibility Criteria
You may qualify if:
- Residing in the community for at least three months;
- Eligible to receive all three agents according to standard MDA criteria
You may not qualify if:
- Not eligible to receive one or more drugs according to standard MDA criteria;
- Less than 5 years of age (not eligible for ivermectin)\*\*
- Pregnant women (azithromycin only, not eligible for albendazole and ivermectin)
- Lactating women (Only administered azithromycin and albendazole, not eligible for ivermectin)\*\*
- History of allergies to the drugs being studied (azithromycin, ivermectin, albendazole)
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Community Recruitment across whole district
Community Recruitment Across Whole District, Ethiopia
Related Publications (1)
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.
PMID: 37152362DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2018
First Posted
June 27, 2018
Study Start
December 1, 2021
Primary Completion
February 1, 2022
Study Completion
February 1, 2022
Last Updated
August 19, 2022
Record last verified: 2022-04