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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04774991
Other study ID # 19-28387B
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date June 28, 2021
Est. completion date November 2024

Study information

Verified date September 2023
Source University of California, San Francisco
Contact Elodie Lebas, RN
Phone 5104232245
Email elodie.lebas@ucsf.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This cluster-randomized trial aims to compare the impact of different delivery approaches to azithromycin distribution on coverage, costs, and feasibility outcomes. The investigators hypothesize that door-to-door delivery will have higher coverage and costs and similar feasibility and acceptability compared to fixed-point delivery.


Description:

Azithromycin distribution has been shown to reduce mortality in children 1-59 months. This trial aims to contribute evidence on viable approaches to implementation as high mortality countries consider this intervention to improve child survival. From a pool of eligible rural and peri-urban communities in the Dosso Region in Niger, 80 will be randomly selected and randomized to receive door-to-door or fixed-point delivery of a single dose of azithromycin distribution to children 1-59 months of age via community health workers biannually. Treatment coverage, costs and cost-effectiveness, and feasibility and acceptability will be compared by arm.


Recruitment information / eligibility

Status Recruiting
Enrollment 12057
Est. completion date November 2024
Est. primary completion date November 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Month and older
Eligibility Inclusion Criteria: At the community-level, eligibility includes: - Location in one of the 80 Dosso communities randomly selected for the delivery trial - Population 250 to 2,499* - Distance > 5 km from the district headquarters town - Verbal consent of community leader(s) At the individual-level, eligibility includes: - Age 1-59 months - Primary residence in a study community - Verbal consent of caregiver/guardian for study participation - Weight = 4 kg Exclusion Criteria: At the community-level, eligibility includes: - Inaccessible or unsafe for study team - "Quartier" designation on national census *Population size as estimated from the most recent national census or projections At the individual-level, eligibility includes: • Known allergy to macrolides

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Azithromycin for Oral Suspension
Azithromycin will be administered as a single dose in oral suspension form for children as follows: Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g) For children 1 to <12 months of age, weight-based dosing will be used For children 12 to 59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program.

Locations

Country Name City State
Niger Program National de Santé Oculaire Niamey

Sponsors (3)

Lead Sponsor Collaborator
University of California, San Francisco Bill and Melinda Gates Foundation, Programme National de Santé Oculaire, Ministère de la Santé Publique du Niger

Country where clinical trial is conducted

Niger, 

Outcome

Type Measure Description Time frame Safety issue
Primary Treatment Coverage Treatment coverage as defined by the number of doses of azithromycin administered in each community divided by the total eligible population 6 months
Secondary Program Costs Program costs as captured by routine administrative data collection during the study period and by micro-costing activities 6 months
Secondary Fidelity of intervention rollout Fidelity of intervention rollout reported as the percent of protocol steps with complete adherence by the field team 6 months
Secondary Acceptability of intervention Participant and provider perception of acceptability of delivery approaches as measured by surveys conducted post-distribution 6 months
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