Cluster RCT of Co-administration Azithromycin, Albendazole & Ivermectin

NCT ID: NCT03570814

Last Updated: 2022-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 13511 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2022-02-01

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.

Conditions

Trachoma; Lymphatic Filariases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Separate Administration

Standard administration of Albendazole/Ivermectin separated from administration of azithromycin

Group Type: ACTIVE_COMPARATOR

Administration of Albendazole on Day 1

Intervention Type: DRUG

Participants will receive Albendazole 400mg on study day 1.

Administration of Ivermectin on Day 1

Intervention Type: DRUG

Participants will receive Ivermectin 150mcg/kg (max 12mg) on study day 1. Doses of Ivermectin will be determined using a standard dosing pole.

Administration of Azithromycin on Day 15

Intervention Type: DRUG

Participants will receive Azithromycin 20mg/kg (max 1gm) on study day 15. Doses of Azithromycin will be determined using a standard dosing pole.

Co-administration

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

Group Type: EXPERIMENTAL

Administration of Albendazole on Day 1

Intervention Type: DRUG

Participants will receive Albendazole 400mg on study day 1.

Administration of Ivermectin on Day 1

Intervention Type: DRUG

Participants will receive Ivermectin 150mcg/kg (max 12mg) on study day 1. Doses of Ivermectin will be determined using a standard dosing pole.

Administration of Azithromycin on Day 1

Intervention Type: DRUG

Participants will receive Azithromycin 20mg/kg (max 1gm) on study day 1. Doses of Azithromycin will be determined using a standard dosing pole.

Interventions

Administration of Albendazole on Day 1

Participants will receive Albendazole 400mg on study day 1.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Armauer Hansen Research Institute, Ethiopia

OTHER

Sponsor Role: collaborator

Federal Minstry of Health of Ethiopia

OTHER_GOV

Sponsor Role: collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Community Recruitment across whole district

Community Recruitment Across Whole District, , Ethiopia

Countries

Ethiopia

References

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.

Reference Type: DERIVED

PMID: 37152362 (View on PubMed)

Other Identifiers

11985

Identifier Type: -

Identifier Source: org_study_id