A Phase 4 interventional study of Azithromycin for Oral Suspension in Mortality, Child Health and Implementation, sponsored by University of California, San Francisco. Completed at 1 site in Niger. Open to participants aged 1 Month and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-24.
Sponsored by University of California, San Francisco · Phase 4, Interventional, and Treatment
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.
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.
University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.
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At the community-level, eligibility includes:
At the individual-level, eligibility includes:
Exclusion Criteria:
At the community-level, eligibility includes:
At the individual-level, eligibility includes:
Azithromycin distribution to children 1-59 months of age using a fixed-point delivery approach via existing community health workers
Drug: Azithromycin for Oral Suspension
Azithromycin distribution to children 1-59 months of age using a door-to-door delivery approach via existing community health workers
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.
Also known as: Zithromax
Treatment Coverage
Treatment coverage as defined by the number of doses of azithromycin administered in each community divided by the total eligible population
Time frame: 6 months
Program Costs
Program costs as captured by routine administrative data collection during the study period and by micro-costing activities
Time frame: 6 months
Fidelity of intervention rollout
Fidelity of intervention rollout reported as the percent of protocol steps with complete adherence by the field team
Time frame: 6 months
Acceptability of intervention
Participant and provider perception of acceptability of delivery approaches as measured by surveys conducted post-distribution
Time frame: 6 months
Plan to share: Yes — Data underlying outcomes publications will be made publicly available.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Individual participant data will be made available after publication of the outcomes and will be made available indefinitely
Access criteria: Once made available, the data will be open access.
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Azithromycin
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