Mass azithromycin distribution and nutritional status among children aged 1-59 months: a secondary analysis of a cluster randomized trial

ABSTRACT

Background Twice yearly distribution of azithromycin has been shown to reduce all-cause child mortality in several contexts. Azithromycin likely reduces mortality via reduction in clinical or subclinical infections. Treating infections may improve child nutritional status to further reduce mortality risk. Here, we used data from a placebo-controlled cluster randomized trial of azithromycin for prevention of child mortality in Burkina Faso to evaluate the effects of twice-yearly azithromycin on mid-upper arm circumference (MUAC) in children aged 1-59 months and weight-for-age Z-score (WAZ) in infants aged 1-11 months.

Methods The Child Health with Azithromycin Trial (CHAT) was a 1:1 cluster randomized trial of twice-yearly azithromycin compared to matching placebo for prevention of all-cause mortality in children aged 1-59 months. MUAC measurements were collected in all children at the time of treatment. Weight measurements were collected in infants aged 1-11 months to calculate weight-based dosing. We evaluated MUAC and WAZ at the community level and longitudinally at the individual child level, accounting for the cluster randomized design of the trial.

Results 80,282 children aged 1-59 months and 26,983 infants aged 1-11 months in 284 communities were included in analyses. At the community level, we found no evidence of a difference in mean MUAC or WAZ after 36 months or over time. There was no evidence of a difference in change over time in MUAC (P-value for interaction = 0.94) or WAZ (P=0.18) at the individual level.

Conclusions We found no evidence to support an effect of twice-yearly mass azithromycin distribution on measures of undernutrition in children in this setting in Burkina Faso.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

NCT03676764

Funding Statement

The CHAT study was supported by the Bill and Melinda Gates Foundation (OPP1187628, PI: Lietman). Azithromycin and matching placebo were donated by Pfizer, Inc (New York, NY).

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The IRB of the University of California San Francisco gave ethical approval for this work. The Comite National dEthique pour la Recherche en Sante gave ethical approval for this work.

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Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

All data produced in the present study are available upon reasonable request to the authors

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