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Azithromycin to Reduce Mortality - An Adaptive Cluster-Randomized Trial.
O'Brien, Kieran S; Arzika, Ahmed M; Amza, Abdou; Maliki, Ramatou; Aichatou, Bawa; Bello, Ismael Mamane; Beidi, Diallo; Galo, Nasser; Harouna, Naser; Karamba, Alio M; Mahamadou, Sani; Abarchi, Moustapha; Ibrahim, Almou; Lebas, Elodie; Peterson, Brittany; Liu, Zijun; Le, Victoria; Colby, Emily; Doan, Thuy; Keenan, Jeremy D; Oldenburg, Catherine E; Porco, Travis C; Arnold, Benjamin F; Lietman, Thomas M.
Afiliación
  • O'Brien KS; From the Francis I. Proctor Foundation (K.S.O., E.L., B.P., Z.L., V.L., E.C., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.), the Departments of Ophthalmology (K.S.O., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.) and Epidemiology and Biostatistics (K.S.O., C.E.O., T.C.P., T.M.L.), and the Institute
  • Arzika AM; From the Francis I. Proctor Foundation (K.S.O., E.L., B.P., Z.L., V.L., E.C., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.), the Departments of Ophthalmology (K.S.O., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.) and Epidemiology and Biostatistics (K.S.O., C.E.O., T.C.P., T.M.L.), and the Institute
  • Amza A; From the Francis I. Proctor Foundation (K.S.O., E.L., B.P., Z.L., V.L., E.C., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.), the Departments of Ophthalmology (K.S.O., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.) and Epidemiology and Biostatistics (K.S.O., C.E.O., T.C.P., T.M.L.), and the Institute
  • Maliki R; From the Francis I. Proctor Foundation (K.S.O., E.L., B.P., Z.L., V.L., E.C., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.), the Departments of Ophthalmology (K.S.O., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.) and Epidemiology and Biostatistics (K.S.O., C.E.O., T.C.P., T.M.L.), and the Institute
  • Aichatou B; From the Francis I. Proctor Foundation (K.S.O., E.L., B.P., Z.L., V.L., E.C., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.), the Departments of Ophthalmology (K.S.O., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.) and Epidemiology and Biostatistics (K.S.O., C.E.O., T.C.P., T.M.L.), and the Institute
  • Bello IM; From the Francis I. Proctor Foundation (K.S.O., E.L., B.P., Z.L., V.L., E.C., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.), the Departments of Ophthalmology (K.S.O., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.) and Epidemiology and Biostatistics (K.S.O., C.E.O., T.C.P., T.M.L.), and the Institute
  • Beidi D; From the Francis I. Proctor Foundation (K.S.O., E.L., B.P., Z.L., V.L., E.C., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.), the Departments of Ophthalmology (K.S.O., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.) and Epidemiology and Biostatistics (K.S.O., C.E.O., T.C.P., T.M.L.), and the Institute
  • Galo N; From the Francis I. Proctor Foundation (K.S.O., E.L., B.P., Z.L., V.L., E.C., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.), the Departments of Ophthalmology (K.S.O., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.) and Epidemiology and Biostatistics (K.S.O., C.E.O., T.C.P., T.M.L.), and the Institute
  • Harouna N; From the Francis I. Proctor Foundation (K.S.O., E.L., B.P., Z.L., V.L., E.C., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.), the Departments of Ophthalmology (K.S.O., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.) and Epidemiology and Biostatistics (K.S.O., C.E.O., T.C.P., T.M.L.), and the Institute
  • Karamba AM; From the Francis I. Proctor Foundation (K.S.O., E.L., B.P., Z.L., V.L., E.C., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.), the Departments of Ophthalmology (K.S.O., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.) and Epidemiology and Biostatistics (K.S.O., C.E.O., T.C.P., T.M.L.), and the Institute
  • Mahamadou S; From the Francis I. Proctor Foundation (K.S.O., E.L., B.P., Z.L., V.L., E.C., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.), the Departments of Ophthalmology (K.S.O., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.) and Epidemiology and Biostatistics (K.S.O., C.E.O., T.C.P., T.M.L.), and the Institute
  • Abarchi M; From the Francis I. Proctor Foundation (K.S.O., E.L., B.P., Z.L., V.L., E.C., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.), the Departments of Ophthalmology (K.S.O., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.) and Epidemiology and Biostatistics (K.S.O., C.E.O., T.C.P., T.M.L.), and the Institute
  • Ibrahim A; From the Francis I. Proctor Foundation (K.S.O., E.L., B.P., Z.L., V.L., E.C., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.), the Departments of Ophthalmology (K.S.O., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.) and Epidemiology and Biostatistics (K.S.O., C.E.O., T.C.P., T.M.L.), and the Institute
  • Lebas E; From the Francis I. Proctor Foundation (K.S.O., E.L., B.P., Z.L., V.L., E.C., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.), the Departments of Ophthalmology (K.S.O., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.) and Epidemiology and Biostatistics (K.S.O., C.E.O., T.C.P., T.M.L.), and the Institute
  • Peterson B; From the Francis I. Proctor Foundation (K.S.O., E.L., B.P., Z.L., V.L., E.C., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.), the Departments of Ophthalmology (K.S.O., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.) and Epidemiology and Biostatistics (K.S.O., C.E.O., T.C.P., T.M.L.), and the Institute
  • Liu Z; From the Francis I. Proctor Foundation (K.S.O., E.L., B.P., Z.L., V.L., E.C., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.), the Departments of Ophthalmology (K.S.O., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.) and Epidemiology and Biostatistics (K.S.O., C.E.O., T.C.P., T.M.L.), and the Institute
  • Le V; From the Francis I. Proctor Foundation (K.S.O., E.L., B.P., Z.L., V.L., E.C., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.), the Departments of Ophthalmology (K.S.O., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.) and Epidemiology and Biostatistics (K.S.O., C.E.O., T.C.P., T.M.L.), and the Institute
  • Colby E; From the Francis I. Proctor Foundation (K.S.O., E.L., B.P., Z.L., V.L., E.C., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.), the Departments of Ophthalmology (K.S.O., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.) and Epidemiology and Biostatistics (K.S.O., C.E.O., T.C.P., T.M.L.), and the Institute
  • Doan T; From the Francis I. Proctor Foundation (K.S.O., E.L., B.P., Z.L., V.L., E.C., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.), the Departments of Ophthalmology (K.S.O., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.) and Epidemiology and Biostatistics (K.S.O., C.E.O., T.C.P., T.M.L.), and the Institute
  • Keenan JD; From the Francis I. Proctor Foundation (K.S.O., E.L., B.P., Z.L., V.L., E.C., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.), the Departments of Ophthalmology (K.S.O., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.) and Epidemiology and Biostatistics (K.S.O., C.E.O., T.C.P., T.M.L.), and the Institute
  • Oldenburg CE; From the Francis I. Proctor Foundation (K.S.O., E.L., B.P., Z.L., V.L., E.C., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.), the Departments of Ophthalmology (K.S.O., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.) and Epidemiology and Biostatistics (K.S.O., C.E.O., T.C.P., T.M.L.), and the Institute
  • Porco TC; From the Francis I. Proctor Foundation (K.S.O., E.L., B.P., Z.L., V.L., E.C., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.), the Departments of Ophthalmology (K.S.O., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.) and Epidemiology and Biostatistics (K.S.O., C.E.O., T.C.P., T.M.L.), and the Institute
  • Arnold BF; From the Francis I. Proctor Foundation (K.S.O., E.L., B.P., Z.L., V.L., E.C., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.), the Departments of Ophthalmology (K.S.O., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.) and Epidemiology and Biostatistics (K.S.O., C.E.O., T.C.P., T.M.L.), and the Institute
  • Lietman TM; From the Francis I. Proctor Foundation (K.S.O., E.L., B.P., Z.L., V.L., E.C., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.), the Departments of Ophthalmology (K.S.O., T.D., J.D.K., C.E.O., T.C.P., B.F.A., T.M.L.) and Epidemiology and Biostatistics (K.S.O., C.E.O., T.C.P., T.M.L.), and the Institute
N Engl J Med ; 391(8): 699-709, 2024 Aug 22.
Article en En | MEDLINE | ID: mdl-39167806
ABSTRACT

BACKGROUND:

Twice-yearly mass distribution of azithromycin to children is a promising intervention to reduce childhood mortality in sub-Saharan Africa. The World Health Organization recommended restricting distribution to infants 1 to 11 months of age to mitigate antimicrobial resistance, although this more limited treatment had not yet been tested.

METHODS:

We randomly assigned rural communities in Niger to four twice-yearly distributions of azithromycin for children 1 to 59 months of age (child azithromycin group), four twice-yearly distributions of azithromycin for infants 1 to 11 months of age and placebo for children 12 to 59 months of age (infant azithromycin group), or placebo for children 1 to 59 months of age. Census workers who were not aware of the group assignments monitored mortality twice yearly over the course of 2 years. We assessed three primary community-level mortality outcomes (deaths per 1000 person-years), each examining a different age group and pairwise group comparison.

RESULTS:

A total of 1273 communities were randomly assigned to the child azithromycin group (1229 were included in the analysis), 773 to the infant azithromycin group (751 included in the analysis), and 954 to the placebo group (929 included in the analysis). Among 382,586 children, 419,440 person-years and 5503 deaths were recorded. Lower mortality among children 1 to 59 months of age was observed in the child azithromycin group (11.9 deaths per 1000 person-years; 95% confidence interval [CI], 11.3 to 12.6) than in the placebo group (13.9 deaths per 1000 person-years; 95% CI, 13.0 to 14.8) (representing 14% lower mortality with azithromycin; 95% CI, 7 to 22; P<0.001). Mortality among infants 1 to 11 months of age was not significantly lower in the infant azithromycin group (22.3 deaths per 1000 person-years; 95% CI, 20.0 to 24.7) than in the placebo group (23.9 deaths per 1000 person-years; 95% CI, 21.6 to 26.2) (representing 6% lower mortality with azithromycin; 95% CI, -8 to 19). Five serious adverse events were reported three in the placebo group, one in the infant azithromycin group, and one in the child azithromycin group.

CONCLUSIONS:

Azithromycin distributions to children 1 to 59 months of age significantly reduced mortality and was more effective than treatment of infants 1 to 11 months of age. Antimicrobial resistance must be monitored. (Funded by the Bill and Melinda Gates Foundation; AVENIR ClinicalTrials.gov number, NCT04224987.).
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Infecciones Bacterianas / Mortalidad Infantil / Azitromicina / Mortalidad del Niño / Administración Masiva de Medicamentos / Antibacterianos Límite: Child, preschool / Female / Humans / Infant / Male País/Región como asunto: Africa Idioma: En Revista: N Engl J Med Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
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XML
PubMed Links
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Infecciones Bacterianas / Mortalidad Infantil / Azitromicina / Mortalidad del Niño / Administración Masiva de Medicamentos / Antibacterianos Límite: Child, preschool / Female / Humans / Infant / Male País/Región como asunto: Africa Idioma: En Revista: N Engl J Med Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos