A Phase 4 interventional study of Administration of Albendazole on Day 1 and Administration of Ivermectin on Day 1 in Trachoma and Lymphatic Filariases, sponsored by London School of Hygiene and Tropical Medicine. Completed at 1 site in Ethiopia. Per ClinicalTrials.gov, last updated 2022-08-19.
Sponsored by London School of Hygiene and Tropical Medicine · Phase 4, Interventional, and Treatment
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.
39 studies on the registry are indexed under Trachoma; 3 are open to participants now.
This study's enrollment of 13,511 is above the median of 1,300 across 31 interventional studies indexed under Trachoma.
Browse Trachoma studies →London School of Hygiene and Tropical Medicine is the lead sponsor of 298 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
Residents who cannot swallow tablets
Standard administration of Albendazole/Ivermectin separated from administration of azithromycin
Drug: Administration of Albendazole on Day 1 · Drug: Administration of Ivermectin on Day 1 · Drug: Administration of Azithromycin on Day 15
Combined administration of Albendazole/Ivermectin/Azithromycin at a single time point
Drug: Administration of Albendazole on Day 1 · Drug: Administration of Ivermectin on Day 1 · Drug: Administration of Azithromycin on Day 1
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.
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,
Time frame: 1 Month
Cost of Administration Drug Separately compared to Cost of Co-Administration of Drugs
Analysis of the cost effectiveness of co-administration compared to separate administration of drugs
Time frame: 1 month
Community perceptions
An 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.
Time frame: 1 month
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Dec 2021 to primary completion in Feb 2022, 2 months.
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This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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London School of Hygiene and Tropical Medicine →