Childhood Mortality After Mass Distribution of Azithromycin: A Secondary Analysis of the PRET Cluster-randomized Trial in Niger

Kieran S. O'Brien, Sun Y. Cotter, Abdou Amza, Boubacar Kadri, Beido Nassirou, Nicole E. Stoller, Zhaoxia Zhou, Sheila K West, Robin L. Bailey, Jeremy D. Keenan, Travis C. Porco, Thomas M. Lietman

Research output: Contribution to journalArticle

Abstract

BACKGROUND: Mass distributions of azithromycin for trachoma have been associated with secondary benefits, including reductions in child mortality.

METHODS: In the Partnership for the Rapid Elimination of Trachoma cluster-randomized trial in Niger, 24 communities were randomized to annual treatment of everyone and 24 communities were randomized to biannual treatment of children under 12 for 3 years (clinicaltrials.gov, NCT00792922). Treatment was a single dose of directly observed oral azithromycin (20 mg/kg up to 1 g in adults). Vital status was assessed during annual census and monitoring visits. In this prespecified secondary analysis, we compared the mortality rate among children 6 months to less than 5 years of age by treatment arm using negative binomial regression.

RESULTS: Among children 6 months to less than 5 years of age, 404 deaths occurred during the study period. The mortality rate was 35.6 deaths per 1000 person-years (231 deaths, 95% CI: 30.9-40.9) in the annual arm and 29.0 deaths per 1000 person-years (173 deaths, 95% CI: 24.8-33.8) in the biannual arm. The mortality rate ratio comparing children in the biannual arm to the annual arm was 0.81 (95% CI: 0.66-1.00, P = 0.07; primary outcome). The mortality rate ratio comparing children who died from infectious causes in the biannual arm to the annual arm was 0.73 (95% CI: 0.57-0.94; P = 0.02). No adverse events were reported.

CONCLUSIONS: This secondary analysis of a cluster-randomized trial found a nonsignificant 19% decrease in mortality among children 6 months to less than 5 years of age who received biannual azithromycin compared with children who received annual azithromycin. This study was conducted in a high mortality, trachoma-endemic area; thus, results may be specific to this environment only. In addition, the trial was neither designed nor powered to detect a mortality effect, and we cannot rule out the possibility that mortality differences resulted from bias.

Original languageEnglish (US)
Pages (from-to)1082-1086
Number of pages5
JournalThe Pediatric infectious disease journal
Volume37
Issue number11
DOIs
StatePublished - Nov 1 2018

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Niger
Azithromycin
Cluster Analysis
Mortality
Trachoma
Child Mortality
Censuses
Therapeutics

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Microbiology (medical)
  • Infectious Diseases

Cite this

Childhood Mortality After Mass Distribution of Azithromycin : A Secondary Analysis of the PRET Cluster-randomized Trial in Niger. / O'Brien, Kieran S.; Cotter, Sun Y.; Amza, Abdou; Kadri, Boubacar; Nassirou, Beido; Stoller, Nicole E.; Zhou, Zhaoxia; West, Sheila K; Bailey, Robin L.; Keenan, Jeremy D.; Porco, Travis C.; Lietman, Thomas M.

In: The Pediatric infectious disease journal, Vol. 37, No. 11, 01.11.2018, p. 1082-1086.

Research output: Contribution to journalArticle

O'Brien, KS, Cotter, SY, Amza, A, Kadri, B, Nassirou, B, Stoller, NE, Zhou, Z, West, SK, Bailey, RL, Keenan, JD, Porco, TC & Lietman, TM 2018, 'Childhood Mortality After Mass Distribution of Azithromycin: A Secondary Analysis of the PRET Cluster-randomized Trial in Niger', The Pediatric infectious disease journal, vol. 37, no. 11, pp. 1082-1086. https://doi.org/10.1097/INF.0000000000001992
O'Brien, Kieran S. ; Cotter, Sun Y. ; Amza, Abdou ; Kadri, Boubacar ; Nassirou, Beido ; Stoller, Nicole E. ; Zhou, Zhaoxia ; West, Sheila K ; Bailey, Robin L. ; Keenan, Jeremy D. ; Porco, Travis C. ; Lietman, Thomas M. / Childhood Mortality After Mass Distribution of Azithromycin : A Secondary Analysis of the PRET Cluster-randomized Trial in Niger. In: The Pediatric infectious disease journal. 2018 ; Vol. 37, No. 11. pp. 1082-1086.
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abstract = "BACKGROUND: Mass distributions of azithromycin for trachoma have been associated with secondary benefits, including reductions in child mortality.METHODS: In the Partnership for the Rapid Elimination of Trachoma cluster-randomized trial in Niger, 24 communities were randomized to annual treatment of everyone and 24 communities were randomized to biannual treatment of children under 12 for 3 years (clinicaltrials.gov, NCT00792922). Treatment was a single dose of directly observed oral azithromycin (20 mg/kg up to 1 g in adults). Vital status was assessed during annual census and monitoring visits. In this prespecified secondary analysis, we compared the mortality rate among children 6 months to less than 5 years of age by treatment arm using negative binomial regression.RESULTS: Among children 6 months to less than 5 years of age, 404 deaths occurred during the study period. The mortality rate was 35.6 deaths per 1000 person-years (231 deaths, 95{\%} CI: 30.9-40.9) in the annual arm and 29.0 deaths per 1000 person-years (173 deaths, 95{\%} CI: 24.8-33.8) in the biannual arm. The mortality rate ratio comparing children in the biannual arm to the annual arm was 0.81 (95{\%} CI: 0.66-1.00, P = 0.07; primary outcome). The mortality rate ratio comparing children who died from infectious causes in the biannual arm to the annual arm was 0.73 (95{\%} CI: 0.57-0.94; P = 0.02). No adverse events were reported.CONCLUSIONS: This secondary analysis of a cluster-randomized trial found a nonsignificant 19{\%} decrease in mortality among children 6 months to less than 5 years of age who received biannual azithromycin compared with children who received annual azithromycin. This study was conducted in a high mortality, trachoma-endemic area; thus, results may be specific to this environment only. In addition, the trial was neither designed nor powered to detect a mortality effect, and we cannot rule out the possibility that mortality differences resulted from bias.",
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T2 - A Secondary Analysis of the PRET Cluster-randomized Trial in Niger

AU - O'Brien, Kieran S.

AU - Cotter, Sun Y.

AU - Amza, Abdou

AU - Kadri, Boubacar

AU - Nassirou, Beido

AU - Stoller, Nicole E.

AU - Zhou, Zhaoxia

AU - West, Sheila K

AU - Bailey, Robin L.

AU - Keenan, Jeremy D.

AU - Porco, Travis C.

AU - Lietman, Thomas M.

PY - 2018/11/1

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N2 - BACKGROUND: Mass distributions of azithromycin for trachoma have been associated with secondary benefits, including reductions in child mortality.METHODS: In the Partnership for the Rapid Elimination of Trachoma cluster-randomized trial in Niger, 24 communities were randomized to annual treatment of everyone and 24 communities were randomized to biannual treatment of children under 12 for 3 years (clinicaltrials.gov, NCT00792922). Treatment was a single dose of directly observed oral azithromycin (20 mg/kg up to 1 g in adults). Vital status was assessed during annual census and monitoring visits. In this prespecified secondary analysis, we compared the mortality rate among children 6 months to less than 5 years of age by treatment arm using negative binomial regression.RESULTS: Among children 6 months to less than 5 years of age, 404 deaths occurred during the study period. The mortality rate was 35.6 deaths per 1000 person-years (231 deaths, 95% CI: 30.9-40.9) in the annual arm and 29.0 deaths per 1000 person-years (173 deaths, 95% CI: 24.8-33.8) in the biannual arm. The mortality rate ratio comparing children in the biannual arm to the annual arm was 0.81 (95% CI: 0.66-1.00, P = 0.07; primary outcome). The mortality rate ratio comparing children who died from infectious causes in the biannual arm to the annual arm was 0.73 (95% CI: 0.57-0.94; P = 0.02). No adverse events were reported.CONCLUSIONS: This secondary analysis of a cluster-randomized trial found a nonsignificant 19% decrease in mortality among children 6 months to less than 5 years of age who received biannual azithromycin compared with children who received annual azithromycin. This study was conducted in a high mortality, trachoma-endemic area; thus, results may be specific to this environment only. In addition, the trial was neither designed nor powered to detect a mortality effect, and we cannot rule out the possibility that mortality differences resulted from bias.

AB - BACKGROUND: Mass distributions of azithromycin for trachoma have been associated with secondary benefits, including reductions in child mortality.METHODS: In the Partnership for the Rapid Elimination of Trachoma cluster-randomized trial in Niger, 24 communities were randomized to annual treatment of everyone and 24 communities were randomized to biannual treatment of children under 12 for 3 years (clinicaltrials.gov, NCT00792922). Treatment was a single dose of directly observed oral azithromycin (20 mg/kg up to 1 g in adults). Vital status was assessed during annual census and monitoring visits. In this prespecified secondary analysis, we compared the mortality rate among children 6 months to less than 5 years of age by treatment arm using negative binomial regression.RESULTS: Among children 6 months to less than 5 years of age, 404 deaths occurred during the study period. The mortality rate was 35.6 deaths per 1000 person-years (231 deaths, 95% CI: 30.9-40.9) in the annual arm and 29.0 deaths per 1000 person-years (173 deaths, 95% CI: 24.8-33.8) in the biannual arm. The mortality rate ratio comparing children in the biannual arm to the annual arm was 0.81 (95% CI: 0.66-1.00, P = 0.07; primary outcome). The mortality rate ratio comparing children who died from infectious causes in the biannual arm to the annual arm was 0.73 (95% CI: 0.57-0.94; P = 0.02). No adverse events were reported.CONCLUSIONS: This secondary analysis of a cluster-randomized trial found a nonsignificant 19% decrease in mortality among children 6 months to less than 5 years of age who received biannual azithromycin compared with children who received annual azithromycin. This study was conducted in a high mortality, trachoma-endemic area; thus, results may be specific to this environment only. In addition, the trial was neither designed nor powered to detect a mortality effect, and we cannot rule out the possibility that mortality differences resulted from bias.

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