Infant Mortality Reduction by the Mass Administration of Azithromycin
- Registration Number
- NCT04716712
- Lead Sponsor
- University of California, San Francisco
- Brief Summary
This trial will investigate the supplementation of azithromycin distribution to the "Child Health Days" platform in Burkina Faso for child mortality reduction. This distribution will pair door-to-door administration of vitamin A and azithromycin or placebo with acute malnutrition screening among children 1-11 months old.
- Detailed Description
The MORDOR clinical trial funded by the Bill \& Melinda Gates Foundation in Malawi, Tanzania, and Niger demonstrated that biannual oral azithromycin distributions to children aged 1-59 months significantly reduced child mortality. The investigators hypothesize that biannual administration of azithromycin to children aged 1-11 months will reduce mortality in this age group. The aim of the project is to demonstrate that this intervention can be scaled up and produce the same benefits on mortality as those documented in smaller, more controlled studies. Since 1986, to reduce child mortality, Burkina Faso has been administering high-dose vitamin A supplementation to children aged 6-59 months on a biannual basis through the "Child Health Days" platform. The "Child Health days" are a door-to-door distribution of vitamin A coupled with screening for acute malnutrition in children aged 6-59 months and deworming of children aged 12-59 months. This approach has been successful but expensive. A new strategy implemented since September 2017 relies on community-based health workers (CBHWs) to distribute Vitamin A in rural areas, and on community-based distributors (CDs) in urban areas. Based on expert opinion and the preliminary findings of formative research conducted by the Ministry of Health and Helen Keller International, it was agreed that the Child Health Days platform was the most appropriate platform to implement the biannual administration of azithromycin to children aged 1 to 11 months.
In this trial, mortality will be measured via complete birth history which will be collected in a subset of villages in the study area before the first treatment distribution. The study team will also conduct a baseline census of the study areas for treatment coverage estimations.
Sixty villages (30 azithromycin, 30 placebo) will contribute to the macrolide resistance outcomes, where the study team will collect rectal and nasal swabs from children 1-59 months.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 694400
Community eligibility criteria:
- Located in one of the three selected regions: SudOuest, Centre-Ouest, Hauts-Bassins
- Verbal consent of the community leader is obtained
Inclusion criteria for children:
- Aged 1 to 11 months
- Living in one of the communities participating in the study
Community exclusion criteria:
• Inaccessible or unsafe for the study team
Exclusion criteria for children:
• Known allergy to macrolides
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Biannual mass placebo + child health days Placebo Bi-annual Mass placebo distribution to all children 1-11 months old in participating communities paired with the Child Health Days Vitamin A distribution platform Resistance Sub Study: Placebo + Child Health Days Placebo Antimicrobial resistance will be monitored in a parallel study of communities from the target study area. 60 communities will be randomly selected among eligible communities, and randomized in a 1 : 1 fashion Biannual mass oral azithromycin + child health days Azithromycin Bi-annual Mass Azithromycin distribution to all children 1-11 months old in participating communities paired with the Child Health Days Vitamin A distribution platform Resistance Sub Study: Azithromycin + Child Health Days Azithromycin Antimicrobial resistance will be monitored in a parallel study of communities from the target study area. 60 communities will be randomly selected among eligible communities, and randomized in a 1 : 1 fashion
- Primary Outcome Measures
Name Time Method All-cause mortality 24 months following baseline a) Evaluate whether azithromycin integrated within the VAD+ platform reduces mortality in children aged 1-11 months old compared to placebo
- Secondary Outcome Measures
Name Time Method Antimicrobial Resistance (AMR) 24 months b) To compare the cluster level load of genetic determinants of macrolides resistance in rectal samples collected from children 1-59 months old in the clusters receiving azithromycin compared to the clusters receiving placebo
Clinic Visits 24 months b) Evaluate whether azithromycin integrated within the VAD+ platform changes the rate of clinic visits in children aged 1-11 month old compared to placebo.
Trial Locations
- Locations (3)
University of California, San Francisco
🇺🇸San Francisco, California, United States
Centre de Recherche en Sante de Nouna
🇧🇫Nouna, Burkina Faso
Helen Keller International
🇧🇫Ouagadougou, Burkina Faso