Community Health Azithromycin Trial in Burkina Faso (NCT03676764) | Clinical Trial Compass
CompletedPhase 4
Community Health Azithromycin Trial in Burkina Faso
Burkina Faso77,664 participantsStarted 2019-08-01
Plain-language summary
An estimated 7.7 million pre-school aged children die each year, the majority from infectious diseases. Mass azithromycin distributions for trachoma may have the unintended benefit of reducing childhood mortality. We recently demonstrated the biannual mass azithromycin distribution significantly reduces all-cause child mortality in a cluster randomized trial (MORDOR I) conducted in three diverse regions of Sub-Saharan Africa.
Our long-term goal is to more precisely define the role of mass azithromycin treatments as an intervention for reducing childhood morbidity and mortality. We propose a cluster randomized trial designed to repeat the original study to confirm the original results in a different geographic study with similarly high child mortality, and to better understand the mechanism behind any effect of azithromycin on child mortality. We hypothesize that biannual mass azithromycin distribution will reduce child mortality compared to placebo, and that this effect will be primarily driven by a reduction in infectious burden.
Objectives:
1. Determine the efficacy of biannual mass azithromycin distribution versus placebo in children aged 1-59 months for reduction in all-cause mortality.
2. Determine the efficacy of targeted azithromycin distribution to infants during an early infant healthcare visit (approximately 5th through 12th week of life) on infant mortality.
3. Determine the mechanism behind the effect of biannual mass azithromycin distribution for reduction in child mortality.
The study will be conducted in the Nouna District in northwestern Burkina Faso.
Who can participate
Age range
1 Month – 59 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.
Communities:
Inclusion Criteria:
* The community location in target district.
* The community leader consents to participation in the trial (this does not obviate the need for individual consent, but without overall leadership consent, the community as a whole cannot be part of the trial).
* Eligible communities estimated population of between 200-2,000 people
* The community is not in an urban area
Exclusion criteria:
\- Refusal of village chief
Individuals:
Inclusion Criteria
* All children in the study communities aged 5 to 12 weeks old at the time of the vaccination visit are eligible to participate
* Ability to feed orally
* Appropriate consent from at least one caregiver
* Family intends to stay within the study area
Exclusion Criteria:
* Individuals allergic to macrolides or azalides will not be given the study antibiotic azithromycin, but will be included in the outcome
* Refusal of parent or guardian
* Child unable to orally feed
* Family planning to move
* Children younger than 28 days old or older than 12 weeks
* Children in the bi annual drug administration group who weight less than 3.8kg.
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
All-cause Mortality Rate in Children Aged 1-59 Months
Timeframe: 36 months
2
All-cause Mortality Rate in Individually Randomized Children at 4-12 Weeks of Age