Gut and Azithromycin Mechanisms in Infants and Children II
Status:
Active, not recruiting
Trial end date:
2023-06-01
Target enrollment:
Participant gender:
Summary
Childhood mortality is decreasing worldwide. However, many sub-Saharan countries still have
high children under 5 mortality rates. The MORDOR trial in Niger, Tanzania, and Malawi
demonstrated a near 14% decrease in all-cause child mortality following biannual azithromycin
in children 1-59 months. Current trials in Burkina aim to replicate these results from the
MORDOR study with mass azithromycin treatment.
The investigators conducted an individually randomized placebo-controlled trial in Burkina
Faso called the Gut and Azithromycin Mechanisms in Infants and Neonates Trial (GAMIN:
NCT03676751) to evaluate the effect of a single dose of azithromycin (20 mg/kg) on potential
mediators of the effect of azithromycin on all-cause mortality and to evaluate changes in the
gut microbiome longitudinally (results pending). Here, the investigators propose to conduct
an expansion of the original GAMIN trial. In GAMIN II, the investigators will evaluate 450
additional 1-59 month old children longitudinally for 6 months with a focus on stool
collection and malaria status.
Objectives:
1. To determine the effect of a single dose of azithromycin for children aged 8 days-59
months on malaria. The investigators hypothesize that a single dose of azithromycin will
result in a reduced malaria status within the treatment group compared to the placebo group
after a 14 day period within children ages 8 days-59 months.
The study will be conducted in Nouna Town in northwestern Burkina Faso.
Phase:
Phase 4
Details
Lead Sponsor:
University of California, San Francisco
Collaborator:
Centre de Recherche en Sante de Nouna, Burkina Faso