A large-scale trial conducted in Mali to determine whether the mass administration of azithromycin to asymptomatic children can reduce the high mortality rate of 1–11-month-old children.
Type of programme
Clinical trial
Objectives
Primary research questions:
1. Does biannual mass drug administration (MDA) of azithromycin (2-dose azithromycin) to 1–11-month-old infants reduce their mortality in a Mali-like setting?
2. Does quarterly (4-dose azithromycin) MDA have a bigger effect than 2-dose MDA?
3. Do selected background variables (such as infant weight for age) modify the effects of 2-dose or 4-dose azithromycin MDA on mortality?
Secondary research questions:
4. Does 2-dose or 4-dose azithromycin MDA reduce morbidity or increase length gain among 1–11-month- old infants?
5. Does 2-dose or 4-dose azithromycin MDA increase nasal or rectal colonization with azithromycin-resistant bacteria among 1–11-month-old infants?
6. What are the cost, cost-effectiveness and other feasibility issues relating to 2-dose and 4-dose azithromycin MDA in Mali?
7. What are the possible biological mechanisms, and how might azithromycin MDA reduce infant mortality?
Study design
Cluster-randomized, placebo control, double-blind trial
Study location and population
Kita, Koulikoro, Kati regions in Mali; 1–11-month-old infants
Schedule
Start date:
15 October 2020
End date:
31 December 2024
Anticipated date key findings will become available:
30 September 2024
Decisions and policies informed by data:
Use of azithromycin MDA to reduce infant mortality
Personnel and study partners
Study PI: Prof. Per Ashorn
Co-PIs: Prof. Samba Sow, Prof. Nigel Klein, Dr. Camilla Ducker, Dr. Ulla Ashorn, Prof. Yin Bun Cheung
Study partners (institutions):
CVD-Mali, Tampere University, Tro Da Ltd, University College London
