Resiliency Through Azithromycin for Children (REACH), Côte d'Ivoire (NCT04617626) | Clinical Trial Compass
CompletedNot Applicable
Resiliency Through Azithromycin for Children (REACH), Côte d'Ivoire
Côte d’Ivoire1,735 participantsStarted 2020-11-20
Plain-language summary
The aim of the study is to gather preliminary evidence on the operational feasibility and acceptability of integrating bi-annual mass drug administration (MDA) of single-dose azithromycin for children ages 1 to 11 months in high child mortality settings in Côte. The cross-sectional study will be carried out in conjunction with a single trachoma MDA in selected villages within one health district. Data on feasibility and acceptability will be collected through three main activities:
1. Analyses of existing routine monitoring, process, and adverse drug reaction data from the trachoma MDA platform into which the pilot activities are being integrated
2. A cross-sectional, post-MDA coverage survey
3. Qualitative data collection among targeting parents or primary caregivers of children ages 1 to 11 months in the pilot districts, and district-level MDA implementers, regarding the proposed azithromycin program.
Who can participate
Age range
1 Month – 5 Months
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.
For expanded azithromycin access during the MDA
Inclusion Criteria:
* Child aged 1 month (at least 30 days) to less than 6 months at the beginning of the week of the MDA intervention
* Resident in study communities
Exclusion Criteria:
* Children below 3.0 kg
* Appears severely ill at the time of the MDA (per the CDD's assessment)
* Unable to swallow liquid delivered through a needle-less syringe because of physical limitations
* Known allergy to macrolides, including azithromycin, based on the primary caregiver's report of prior adverse reaction to medication likely to be a macrolide
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.
What they're measuring
1
Proportion of children 1 to 11 months reached with single-dose azithromycin