Mass Azithromycin Distribution to Prevent Child Mortality in Burkina Faso: The CHAT Randomized Clinical Trial.
Catherine E Oldenburg, Mamadou Ouattara, Mamadou Bountogo...
https://pubmed.ncbi.nlm.nih.gov/38349371Actively Recruiting
Phase 4
Age: 1Month - 59Months
All Genders
Healthy Volunteers
ID06358872
Azithromycin for Child Survival in Niger II Monitoring Mortality and Antimicrobial Resistance
Led by University of California, San Francisco · Updated on 2025-06-22
3300000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
C
Centre de recherche et interventions en santé publique (CRISP)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the impact of azithromycin mass drug administration (MDA) on reducing child mortality and its effect on antimicrobial resistance (AMR) in Niger. This adaptive platform trial focuses on monitoring under-5 mortality rates compared to global reduction goals and evaluating the ongoing benefits and risks of azithromycin MDA as the program expands nationally. The study also aims to assess the impact of azithromycin on AMR through population and clinic samples. Children aged 1 to 59 months are enrolled in different groups receiving azithromycin through door-to-door delivery by community health workers. Some groups receive continuous azithromycin distribution for four years, others receive delayed treatment starting after two years, and some stop receiving azithromycin after two years. The drug is given as a single oral suspension dose, carefully measured by age or height using dosing cups or syringes. Participants are monitored over time for mortality outcomes at 2 and 4 years, and for macrolide resistance using nasopharyngeal and rectal swabs. The study collects data on infectious clinic visits and genetic resistance markers. Community and individual eligibility are based on location, safety, age, and consent. The trial includes verbal approval from community leaders and caregivers. Overall participation may last up to four years with ongoing surveillance and data collection.
CONDITIONS
Brief Title
Azithromycin for Child Survival in Niger II
Who Can Participate
Age: 1Month - 59Months
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Located in a region participating in the azithromycin program
- Community designated as rural and safe for study teams
- Selected for participation in monitoring activities
- Verbal approval from community leaders
- Residing in the catchment area of an eligible community
- Female caregivers aged between 12 and 55 years for mortality monitoring
- Children aged 1 to 59 months for antimicrobial resistance monitoring
- Verbal consent from participant or caregiver
You will not qualify if you...
- Community designated as urban or inaccessible/unable to ensure safety for study teams
- Known allergy to macrolide antibiotics such as azithromycin at individual level
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Verbal consent from participant or caregiver is obtained; community approval is required.
Treatment
Duration - Up to 4 years depending on study arm
Participants receive azithromycin as a single oral dose through door-to-door distribution by community health workers to children aged 1-59 months.
Door-to-door administration visits over the treatment period
Follow-up
Duration - Up to 4 years
Participants are monitored for mortality outcomes and antimicrobial resistance through clinic and community-based visits.
Periodic monitoring visits including sample collection for resistance testing and tracking clinic visits due to infections
Trial Site Locations
Total: 1 location
1
Program National de Santé Oculaire
Niamey, Niger
Actively Recruiting
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Research Team
A
Andrea R Picariello, MPH
E
Elodie Lebas
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Published Research Related To This Trial
Azithromycin during Routine Well-Infant Visits to Prevent Death.
Ali Sié, Mamadou Ouattara, Mamadou Bountogo...
https://pubmed.ncbi.nlm.nih.gov/38231623Distance to Health Centers and Effectiveness of Azithromycin Mass Administration for Children in Niger: A Secondary Analysis of the MORDOR Cluster Randomized Trial.
Dennis L Chao, Ahmed M Arzika, Amza Abdou...
https://pubmed.ncbi.nlm.nih.gov/38100110Childhood mortality in a cohort treated with mass azithromycin for trachoma.
Jeremy D Keenan, Berhan Ayele, Teshome Gebre...
https://pubmed.ncbi.nlm.nih.gov/21427395Childhood Mortality After Mass Distribution of Azithromycin: A Secondary Analysis of the PRET Cluster-randomized Trial in Niger.
Kieran S O'Brien, Sun Y Cotter, Abdou Amza...
https://pubmed.ncbi.nlm.nih.gov/29561511Azithromycin to Reduce Childhood Mortality in Sub-Saharan Africa.
Jeremy D Keenan, Robin L Bailey, Sheila K West...
https://pubmed.ncbi.nlm.nih.gov/29694816Gut microbiome alteration in MORDOR I: a community-randomized trial of mass azithromycin distribution.
T Doan, A Hinterwirth, L Worden...
https://pubmed.ncbi.nlm.nih.gov/31406349Cause-specific mortality of children younger than 5 years in communities receiving biannual mass azithromycin treatment in Niger: verbal autopsy results from a cluster-randomised controlled trial.
Jeremy D Keenan, Ahmed M Arzika, Ramatou Maliki...
https://pubmed.ncbi.nlm.nih.gov/31981558Macrolide and Nonmacrolide Resistance with Mass Azithromycin Distribution.
Thuy Doan, Lee Worden, Armin Hinterwirth...
https://pubmed.ncbi.nlm.nih.gov/33176084