Clinical trial NCT03570814: Cluster RCT of Co-administration Azithromycin, Albendazole & Ivermectin
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Trachoma
Lymphatic Filariases
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Armauer Hansen Research Institute, Ethiopia
name: Federal Minstry of Health of Ethiopia
First posted: 2018-06-27
Enrollment: 13511
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomised trial. Approximately 40 clusters per study arm
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Self Reported Adverse Event
timeFrame: 1 Month
Secondary outcomes:
measure: Cost of Administration Drug Separately compared to Cost of Co-Administration of Drugs
timeFrame: 1 month
measure: Community perceptions
timeFrame: 1 month
Other outcomes:
Locations:
city: Community Recruitment Across Whole District
country: Ethiopia
facility: Community Recruitment across whole district
Study officials:
References: