Azithromycin for Child Survival in Niger: Delivery Trial (NCT04774991) | Clinical Trial Compass
CompletedPhase 4
Azithromycin for Child Survival in Niger: Delivery Trial
Niger10,925 participantsStarted 2021-06-28
Plain-language 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.
Who can participate
Age range
1 Month
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.