Mass Azithromycin Distribution to Prevent Child Mortality in Burkina Faso: The CHAT Randomized Clinical Trial.
JAMA
; 331(6): 482-490, 2024 02 13.
Article
in En
| MEDLINE
| ID: mdl-38349371
ABSTRACT
Importance Repeated mass distribution of azithromycin has been shown to reduce childhood mortality by 14% in sub-Saharan Africa. However, the estimated effect varied by location, suggesting that the intervention may not be effective in different geographical areas, time periods, or conditions. Objective:
To evaluate the efficacy of twice-yearly azithromycin to reduce mortality in children in the presence of seasonal malaria chemoprevention. Design, Setting, andParticipants:
This cluster randomized placebo-controlled trial evaluating the efficacy of single-dose azithromycin for prevention of all-cause childhood mortality included 341 communities in the Nouna district in rural northwestern Burkina Faso. Participants were children aged 1 to 59 months living in the study communities.Interventions:
Communities were randomized in a 11 ratio to receive oral azithromycin or placebo distribution. Children aged 1 to 59 months were offered single-dose treatment twice yearly for 3 years (6 distributions) from August 2019 to February 2023. Main Outcomes andMeasures:
The primary outcome was all-cause childhood mortality, measured during a twice-yearly enumerative census.Results:
A total of 34â¯399 children (mean [SD] age, 25.2 [18] months) in the azithromycin group and 33â¯847 children (mean [SD] age, 25.6 [18] months) in the placebo group were included. A mean (SD) of 90.1% (16.0%) of the censused children received the scheduled study drug in the azithromycin group and 89.8% (17.1%) received the scheduled study drug in the placebo group. In the azithromycin group, 498 deaths were recorded over 60â¯592 person-years (8.2 deaths/1000 person-years). In the placebo group, 588 deaths were recorded over 58â¯547 person-years (10.0 deaths/1000 person-years). The incidence rate ratio for mortality was 0.82 (95% CI, 0.67-1.02; P = .07) in the azithromycin group compared with the placebo group. The incidence rate ratio was 0.99 (95% CI, 0.72-1.36) in those aged 1 to 11 months, 0.92 (95% CI, 0.67-1.27) in those aged 12 to 23 months, and 0.73 (95% CI, 0.57-0.94) in those aged 24 to 59 months. Conclusions and Relevance Mortality in children (aged 1-59 months) was lower with biannual mass azithromycin distribution in a setting in which seasonal malaria chemoprevention was also being distributed, but the difference was not statistically significant. The study may have been underpowered to detect a clinically relevant difference. Trial Registration ClinicalTrials.gov Identifier NCT03676764.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Azithromycin
/
Child Mortality
/
Malaria
/
Anti-Bacterial Agents
Type of study:
Clinical_trials
Limits:
Child, preschool
/
Humans
/
Infant
Country/Region as subject:
Africa
Language:
En
Journal:
JAMA
Year:
2024
Document type:
Article
Country of publication:
Estados Unidos