Status:
COMPLETED
Effects of Mass Drug Administration of Azithromycin on Mortality and Other Outcomes Among 1-11 Month Old Infants in Mali
Lead Sponsor:
Tampere University
Collaborating Sponsors:
Center for Vaccine Development CVD-Mali, Bamako, Mali
University College London Hospitals
Conditions:
Mortality
Eligibility:
All Genders
29-364 years
Phase:
PHASE3
Brief Summary
The LAKANA trial will assess the impact on mortality and other health outcomes of quarterly and biannual azithromycin mass drug administration (MDA) when delivered to 1-11-month (29-364 days) old infa...
Detailed Description
Mass drug administration (MDA) of azithromycin has been shown to reduce under-5 mortality in some but not all sub-Saharan African settings. Because of the observed heterogeneity and possible effect mo...
Eligibility Criteria
Inclusion
- On a cluster (village) level:
- Location within Kayes, Kita, or Koulikoro region of Mali
- Considered accessible and safe by the local health authorities and research team
- Considered non-urban by the local health authorities and research team
- Permission from community leadership
- On a household level (for trial enrollment):
- Location within a cluster that is included in the study
- Verbal consent from a head of household or an adult authorized by her / him
- On a child level (for receiving study medication):
- Residence in a household enrolled in the trial
- Age between 29 and 364 days
- Verbal consent from at least one caregiver
Exclusion
- On child level (for not receiving study medication):
- Weight below 3.0 kg
- Known allergy to macrolides, as judged by a caregiver report of the infant experiencing an adverse reaction after oral ingestion of medication, which was deemed likely to be a macrolide by the interviewing data collector.
Key Trial Info
Start Date :
October 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
149201 Patients enrolled
Trial Details
Trial ID
NCT04424511
Start Date
October 15 2020
End Date
December 31 2024
Last Update
May 21 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Center for Vaccine Development CVD-Mali
Bamako, Mali, BP 251