Evidence map›Paper›PMID 30419040›Full record

Trial reportPLoS neglected tropical diseases2018

Safety of azithromycin in infants under six months of age in Niger: A community randomized trial.

Catherine E Oldenburg, Ahmed M Arzika, Ramatou Maliki, Mohamed Salissou Kane, Elodie Lebas, Kathryn J Ray, Catherine Cook, Sun Y Cotter, Zhaoxia Zhou, Sheila K West and 5 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PLoS neglected tropical diseases, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02048007 (Evaluating Impact of Azithromycin Mass Drug Administrations on All-cause Mortality and Antibiotic Resistance), which is not on this map. Cited by 23 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 2 pooled it
4.7field-weighted citation impact, top 5% of its field
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.

NCT02048007 phase4completednot on this map

Evaluating Impact of Azithromycin Mass Drug Administrations on All-cause Mortality and Antibiotic Resistance: Morbidity Study

TypeinterventionalSponsorUniversity of California, San FranciscoRan2014 to 2020Enrolled72,000ConditionsChildhood MortalityArmsAzithromycin, Placebo
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 2 syntheses or guidelines pooled it, 36 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Effect of one prophylactic dose of azithromycin on Bifidobacterium infantis colonization in infants from the Mumta trial.International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2025
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  11. Article
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  14. Review
  15. Trachoma.Nature reviews. Disease primers · 2022
    Review
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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

15 authors at 4 institutions in 3 countries.

Catherine E OldenburgFrancis I. Proctor Foundation, University of California, San Francisco, San Francisco, California, United States of America.ORCID 0000-0002-0763-399X
Ahmed M ArzikaThe Carter Center Niger, Niamey, Niger.
Ramatou MalikiThe Carter Center Niger, Niamey, Niger.
Mohamed Salissou KaneThe Carter Center Niger, Niamey, Niger.
Elodie LebasFrancis I. Proctor Foundation, University of California, San Francisco, San Francisco, California, United States of America.
Kathryn J RayFrancis I. Proctor Foundation, University of California, San Francisco, San Francisco, California, United States of America.
Catherine CookFrancis I. Proctor Foundation, University of California, San Francisco, San Francisco, California, United States of America.
Sun Y CotterFrancis I. Proctor Foundation, University of California, San Francisco, San Francisco, California, United States of America.
Zhaoxia ZhouFrancis I. Proctor Foundation, University of California, San Francisco, San Francisco, California, United States of America.
Sheila K WestThe Dana Center, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America.
Robin BaileyDepartment of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom.
Travis C PorcoFrancis I. Proctor Foundation, University of California, San Francisco, San Francisco, California, United States of America.
Jeremy D KeenanFrancis I. Proctor Foundation, University of California, San Francisco, San Francisco, California, United States of America.
Thomas M LietmanFrancis I. Proctor Foundation, University of California, San Francisco, San Francisco, California, United States of America.
MORDOR Study Group
University of California, San Francisco · USUnited Nations Children's Fund Niger · NEJohns Hopkins University · USLondon School of Hygiene & Tropical Medicine · GB

Funding

The Brown Initiative in HIV and AIDS Clinical Research for Minority CommunitiesR25MH083620 · NIMH · MIRIAM HOSPITAL · PI NUNN, AMY STEWART · 2008 to 2025
$3.7M
NIMH NIH HHS R25 MH083620
6 · The paper itself

Abstract

backgroundMass azithromycin distribution reduces under-5 child mortality. Trachoma control programs currently treat infants aged 6 months and older. Here, we report findings from an infant adverse event survey in 1-5 month olds who received azithromycin as part of a large community-randomized trial in Niger. METHODS AND PRINCIPAL

findingsActive surveillance of infants aged 1-5 months at the time of treatment was conducted in 30 randomly selected communities from within a large cluster randomized trial of biannual mass azithromycin distribution compared to placebo to assess the potential impact on child mortality. We compared the distribution of adverse events reported after treatment among azithromycin-treated versus placebo-treated infants. From January 2015 to February 2018, the caregivers of 1,712 infants were surveyed. Approximately one-third of caregivers reported at least one adverse event (azithromycin: 29.6%, placebo: 34.3%, risk ratio [RR] 0.86, 95% confidence interval [CI] 0.68 to 1.10, P = 0.23). The most commonly reported adverse events included diarrhea (azithromycin: 19.3%, placebo: 28.1%, RR 0.68, 95% CI 0.49 to 0.96, P = 0.03), vomiting (azithromycin: 15.9%, placebo: 21.0%, RR 0.76, 95% CI 0.56 to 1.02, P = 0.07), and skin rash (azithromycin: 12.3%, placebo: 13.6%, RR 0.90, 95% CI 0.59 to 1.37, P = 0.63). No cases of infantile hypertrophic pyloric stenosis were reported.

conclusionsAzithromycin given to infants aged 1-5 months appeared to be safe. Inclusion of younger infants in larger azithromycin-based child mortality or trachoma control programs could be considered if deemed effective.

trial registrationClinicalTrials.gov NCT02048007.

Indexed as

Age FactorsAnti-Bacterial AgentsAzithromycinChlamydia trachomatisFemaleHumansInfantInfant MortalityMaleNigerTrachomaAnti-Bacterial AgentsAzithromycin

Identifiers

PMID30419040
PMCPMC6258425
OpenAlexW2901408395

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.