Azithromycin during Routine Well-Infant Visits to Prevent Death.

Journal

The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562

Informations de publication

Date de publication:
18 Jan 2024
Historique:
medline: 17 1 2024
pubmed: 17 1 2024
entrez: 17 1 2024
Statut: ppublish

Résumé

Mass distribution of azithromycin to children 1 to 59 months of age has been shown to reduce childhood all-cause mortality in some sub-Saharan African regions, with the largest reduction seen among infants younger than 12 months of age. Whether the administration of azithromycin at routine health care visits for infants would be effective in preventing death is unclear. We conducted a randomized, placebo-controlled trial of a single dose of azithromycin (20 mg per kilogram of body weight) as compared with placebo, administered during infancy (5 to 12 weeks of age). The primary end point was death before 6 months of age. Infants were recruited at routine vaccination or other well-child visits in clinics and through community outreach in three regions of Burkina Faso. Vital status was assessed at 6 months of age. Of the 32,877 infants enrolled from September 2019 through October 2022, a total of 16,416 infants were randomly assigned to azithromycin and 16,461 to placebo. Eighty-two infants in the azithromycin group and 75 infants in the placebo group died before 6 months of age (hazard ratio, 1.09; 95% confidence interval [CI], 0.80 to 1.49; P = 0.58); the absolute difference in mortality was 0.04 percentage points (95% CI, -0.10 to 0.21). There was no evidence of an effect of azithromycin on mortality in any of the prespecified subgroups, including subgroups defined according to age, sex, and baseline weight, and no evidence of a difference between the two trial groups in the incidence of adverse events. In this trial conducted in Burkina Faso, we found that administration of azithromycin to infants through the existing health care system did not prevent death. (Funded by the Bill and Melinda Gates Foundation; CHAT ClinicalTrials.gov number, NCT03676764.).

Sections du résumé

BACKGROUND BACKGROUND
Mass distribution of azithromycin to children 1 to 59 months of age has been shown to reduce childhood all-cause mortality in some sub-Saharan African regions, with the largest reduction seen among infants younger than 12 months of age. Whether the administration of azithromycin at routine health care visits for infants would be effective in preventing death is unclear.
METHODS METHODS
We conducted a randomized, placebo-controlled trial of a single dose of azithromycin (20 mg per kilogram of body weight) as compared with placebo, administered during infancy (5 to 12 weeks of age). The primary end point was death before 6 months of age. Infants were recruited at routine vaccination or other well-child visits in clinics and through community outreach in three regions of Burkina Faso. Vital status was assessed at 6 months of age.
RESULTS RESULTS
Of the 32,877 infants enrolled from September 2019 through October 2022, a total of 16,416 infants were randomly assigned to azithromycin and 16,461 to placebo. Eighty-two infants in the azithromycin group and 75 infants in the placebo group died before 6 months of age (hazard ratio, 1.09; 95% confidence interval [CI], 0.80 to 1.49; P = 0.58); the absolute difference in mortality was 0.04 percentage points (95% CI, -0.10 to 0.21). There was no evidence of an effect of azithromycin on mortality in any of the prespecified subgroups, including subgroups defined according to age, sex, and baseline weight, and no evidence of a difference between the two trial groups in the incidence of adverse events.
CONCLUSIONS CONCLUSIONS
In this trial conducted in Burkina Faso, we found that administration of azithromycin to infants through the existing health care system did not prevent death. (Funded by the Bill and Melinda Gates Foundation; CHAT ClinicalTrials.gov number, NCT03676764.).

Identifiants

DOI: 10.1056/NEJMoa2309495 PMID: 38231623
pubmed: 38231623
doi: 10.1056/NEJMoa2309495
doi:

Banques de données

ClinicalTrials.gov
['NCT03676764']

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

221-229

Subventions

Organisme : Bill and Melinda Gates Foundation
ID : OPP1187628

Informations de copyright

Copyright © 2024 Massachusetts Medical Society.

Auteurs

Ali Sié (A)

From Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso (A.S., M.O., M.B., V.B., T.O., G.C., C.D., C.B.); and the Francis I. Proctor Foundation (E.L., H.H., T.C.P., B.F.A., T.M.L., C.E.O., J.R.), the Department of Epidemiology and Biostatistics (T.C.P., T.M.L., C.E.O.), the Department of Ophthalmology (T.C.P., B.F.A., T.M.L., C.E.O.), and the Institute for Global Health Sciences (T.M.L., C.E.O.), University of California, San Francisco, San Francisco.

Mamadou Ouattara (M)

From Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso (A.S., M.O., M.B., V.B., T.O., G.C., C.D., C.B.); and the Francis I. Proctor Foundation (E.L., H.H., T.C.P., B.F.A., T.M.L., C.E.O., J.R.), the Department of Epidemiology and Biostatistics (T.C.P., T.M.L., C.E.O.), the Department of Ophthalmology (T.C.P., B.F.A., T.M.L., C.E.O.), and the Institute for Global Health Sciences (T.M.L., C.E.O.), University of California, San Francisco, San Francisco.

Mamadou Bountogo (M)

From Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso (A.S., M.O., M.B., V.B., T.O., G.C., C.D., C.B.); and the Francis I. Proctor Foundation (E.L., H.H., T.C.P., B.F.A., T.M.L., C.E.O., J.R.), the Department of Epidemiology and Biostatistics (T.C.P., T.M.L., C.E.O.), the Department of Ophthalmology (T.C.P., B.F.A., T.M.L., C.E.O.), and the Institute for Global Health Sciences (T.M.L., C.E.O.), University of California, San Francisco, San Francisco.

Valentin Boudo (V)

From Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso (A.S., M.O., M.B., V.B., T.O., G.C., C.D., C.B.); and the Francis I. Proctor Foundation (E.L., H.H., T.C.P., B.F.A., T.M.L., C.E.O., J.R.), the Department of Epidemiology and Biostatistics (T.C.P., T.M.L., C.E.O.), the Department of Ophthalmology (T.C.P., B.F.A., T.M.L., C.E.O.), and the Institute for Global Health Sciences (T.M.L., C.E.O.), University of California, San Francisco, San Francisco.

Thierry Ouedraogo (T)

From Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso (A.S., M.O., M.B., V.B., T.O., G.C., C.D., C.B.); and the Francis I. Proctor Foundation (E.L., H.H., T.C.P., B.F.A., T.M.L., C.E.O., J.R.), the Department of Epidemiology and Biostatistics (T.C.P., T.M.L., C.E.O.), the Department of Ophthalmology (T.C.P., B.F.A., T.M.L., C.E.O.), and the Institute for Global Health Sciences (T.M.L., C.E.O.), University of California, San Francisco, San Francisco.

Guillaume Compaoré (G)

From Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso (A.S., M.O., M.B., V.B., T.O., G.C., C.D., C.B.); and the Francis I. Proctor Foundation (E.L., H.H., T.C.P., B.F.A., T.M.L., C.E.O., J.R.), the Department of Epidemiology and Biostatistics (T.C.P., T.M.L., C.E.O.), the Department of Ophthalmology (T.C.P., B.F.A., T.M.L., C.E.O.), and the Institute for Global Health Sciences (T.M.L., C.E.O.), University of California, San Francisco, San Francisco.

Clarisse Dah (C)

From Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso (A.S., M.O., M.B., V.B., T.O., G.C., C.D., C.B.); and the Francis I. Proctor Foundation (E.L., H.H., T.C.P., B.F.A., T.M.L., C.E.O., J.R.), the Department of Epidemiology and Biostatistics (T.C.P., T.M.L., C.E.O.), the Department of Ophthalmology (T.C.P., B.F.A., T.M.L., C.E.O.), and the Institute for Global Health Sciences (T.M.L., C.E.O.), University of California, San Francisco, San Francisco.

Cheik Bagagnan (C)

From Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso (A.S., M.O., M.B., V.B., T.O., G.C., C.D., C.B.); and the Francis I. Proctor Foundation (E.L., H.H., T.C.P., B.F.A., T.M.L., C.E.O., J.R.), the Department of Epidemiology and Biostatistics (T.C.P., T.M.L., C.E.O.), the Department of Ophthalmology (T.C.P., B.F.A., T.M.L., C.E.O.), and the Institute for Global Health Sciences (T.M.L., C.E.O.), University of California, San Francisco, San Francisco.

Elodie Lebas (E)

From Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso (A.S., M.O., M.B., V.B., T.O., G.C., C.D., C.B.); and the Francis I. Proctor Foundation (E.L., H.H., T.C.P., B.F.A., T.M.L., C.E.O., J.R.), the Department of Epidemiology and Biostatistics (T.C.P., T.M.L., C.E.O.), the Department of Ophthalmology (T.C.P., B.F.A., T.M.L., C.E.O.), and the Institute for Global Health Sciences (T.M.L., C.E.O.), University of California, San Francisco, San Francisco.

Huiyu Hu (H)

From Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso (A.S., M.O., M.B., V.B., T.O., G.C., C.D., C.B.); and the Francis I. Proctor Foundation (E.L., H.H., T.C.P., B.F.A., T.M.L., C.E.O., J.R.), the Department of Epidemiology and Biostatistics (T.C.P., T.M.L., C.E.O.), the Department of Ophthalmology (T.C.P., B.F.A., T.M.L., C.E.O.), and the Institute for Global Health Sciences (T.M.L., C.E.O.), University of California, San Francisco, San Francisco.

Jessica Rice (J)

From Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso (A.S., M.O., M.B., V.B., T.O., G.C., C.D., C.B.); and the Francis I. Proctor Foundation (E.L., H.H., T.C.P., B.F.A., T.M.L., C.E.O., J.R.), the Department of Epidemiology and Biostatistics (T.C.P., T.M.L., C.E.O.), the Department of Ophthalmology (T.C.P., B.F.A., T.M.L., C.E.O.), and the Institute for Global Health Sciences (T.M.L., C.E.O.), University of California, San Francisco, San Francisco.

Travis C Porco (TC)

From Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso (A.S., M.O., M.B., V.B., T.O., G.C., C.D., C.B.); and the Francis I. Proctor Foundation (E.L., H.H., T.C.P., B.F.A., T.M.L., C.E.O., J.R.), the Department of Epidemiology and Biostatistics (T.C.P., T.M.L., C.E.O.), the Department of Ophthalmology (T.C.P., B.F.A., T.M.L., C.E.O.), and the Institute for Global Health Sciences (T.M.L., C.E.O.), University of California, San Francisco, San Francisco.

Benjamin F Arnold (BF)

From Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso (A.S., M.O., M.B., V.B., T.O., G.C., C.D., C.B.); and the Francis I. Proctor Foundation (E.L., H.H., T.C.P., B.F.A., T.M.L., C.E.O., J.R.), the Department of Epidemiology and Biostatistics (T.C.P., T.M.L., C.E.O.), the Department of Ophthalmology (T.C.P., B.F.A., T.M.L., C.E.O.), and the Institute for Global Health Sciences (T.M.L., C.E.O.), University of California, San Francisco, San Francisco.

Thomas M Lietman (TM)

From Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso (A.S., M.O., M.B., V.B., T.O., G.C., C.D., C.B.); and the Francis I. Proctor Foundation (E.L., H.H., T.C.P., B.F.A., T.M.L., C.E.O., J.R.), the Department of Epidemiology and Biostatistics (T.C.P., T.M.L., C.E.O.), the Department of Ophthalmology (T.C.P., B.F.A., T.M.L., C.E.O.), and the Institute for Global Health Sciences (T.M.L., C.E.O.), University of California, San Francisco, San Francisco.

Catherine E Oldenburg (CE)

From Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso (A.S., M.O., M.B., V.B., T.O., G.C., C.D., C.B.); and the Francis I. Proctor Foundation (E.L., H.H., T.C.P., B.F.A., T.M.L., C.E.O., J.R.), the Department of Epidemiology and Biostatistics (T.C.P., T.M.L., C.E.O.), the Department of Ophthalmology (T.C.P., B.F.A., T.M.L., C.E.O.), and the Institute for Global Health Sciences (T.M.L., C.E.O.), University of California, San Francisco, San Francisco.

Classifications MeSH