Evidence map›Paper›PMID 29561511›Full record

Trial reportThe Pediatric infectious disease journal2018

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 and 2 more

2 registry-linked trialsAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Pediatric infectious disease journal, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 18 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 4 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00792922 phase4completednot on this map

Research to Programs for Trachoma Elimination: Antibiotic Trial

TypeinterventionalSponsorJohns Hopkins UniversityRan2008 to 2014Enrolled128ConditionsTrachomaArmsAzithromycin
NCT06358872 phase4recruitingnot on this mapstarted 2024, after this paper: background citation

Azithromycine Pour la Vie Des Enfants au Niger II

TypeinterventionalSponsorUniversity of California, San FranciscoRan2024 to 2028Enrolled3,300,000ConditionsMortality, Antimicrobial ResistanceArmsAzithromycin for Oral Suspension
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Antibiotics for trachoma.The Cochrane database of systematic reviews · 2019
    Pooled it
  4. Pooled it
  5. Trial
  6. Trial
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  8. Trial
  9. Anthropometry and Malaria among Children in Niger: A Cross-Sectional Study.The American journal of tropical medicine and hygiene · 2018
    Trial
  10. Article
  11. Review
  12. Article
  13. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Kieran S O'BrienFrom the Francis I. Proctor Foundation, University of California San Francisco, San Francisco, California.
Sun Y CotterFrom the Francis I. Proctor Foundation, University of California San Francisco, San Francisco, California.
Abdou AmzaProgramme FSS/Université Abdou Moumouni de Niamey, Programme National de Santé Oculaire, Niamey, Niger.
Boubacar KadriProgramme FSS/Université Abdou Moumouni de Niamey, Programme National de Santé Oculaire, Niamey, Niger.
Beido NassirouProgramme FSS/Université Abdou Moumouni de Niamey, Programme National de Santé Oculaire, Niamey, Niger.
Nicole E StollerFrom the Francis I. Proctor Foundation, University of California San Francisco, San Francisco, California.
Zhaoxia ZhouFrom the Francis I. Proctor Foundation, University of California San Francisco, San Francisco, California.
Sheila K WestDana Center for Preventive Ophthalmology, Wilmer Eye Institute, Johns Hopkins University, Baltimore, Marlyland.
Robin L BaileyClinical Research Unit, Department of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, United Kingdom.
Jeremy D KeenanFrom the Francis I. Proctor Foundation, University of California San Francisco, San Francisco, California.
Travis C PorcoFrom the Francis I. Proctor Foundation, University of California San Francisco, San Francisco, California.
Thomas M LietmanFrom the Francis I. Proctor Foundation, University of California San Francisco, San Francisco, California.

Funding

CTSA: K12 COMPONENTKL2RR024130 · NCRR · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI JOHNSTON, S. CLAIBORNE · 2006 to 2011
$19.3M
Primary and Secondary Effects of Mass Antibiotic Distributions for TrachomaK23EY019881 · NEI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GAYNOR, BRUCE D. · 2010 to 2014
$1.1M
NCRR NIH HHS KL2 RR024130NEI NIH HHS K23 EY019881
6 · The paper itself

Abstract

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

methodsIn 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.

resultsAmong 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.

conclusionsThis 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.

Indexed as

Child MortalityMass Drug AdministrationAdministration, OralAnti-Bacterial AgentsAzithromycinChildChild, PreschoolCommunicable DiseasesFemaleHumansInfantMaleNigerPrevalenceTrachomaAnti-Bacterial AgentsAzithromycin

Identifiers

PMID29561511
PMCPMC6138579

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.