Safety of azithromycin in infants under six months of age in Niger: A community randomized trial.
BACKGROUND:Mass 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...
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ftdoajarticles:oai:doaj.org/article:0b30e3e60c88490781d3034b439ae38f 2023-05-15T15:11:23+02:00 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 Robin Bailey Travis C Porco Jeremy D Keenan Thomas M Lietman MORDOR Study Group 2018-11-01T00:00:00Z https://doi.org/10.1371/journal.pntd.0006950 https://doaj.org/article/0b30e3e60c88490781d3034b439ae38f EN eng Public Library of Science (PLoS) http://europepmc.org/articles/PMC6258425?pdf=render https://doaj.org/toc/1935-2727 https://doaj.org/toc/1935-2735 1935-2727 1935-2735 doi:10.1371/journal.pntd.0006950 https://doaj.org/article/0b30e3e60c88490781d3034b439ae38f PLoS Neglected Tropical Diseases, Vol 12, Iss 11, p e0006950 (2018) Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 article 2018 ftdoajarticles https://doi.org/10.1371/journal.pntd.0006950 2022-12-31T08:17:08Z BACKGROUND:Mass 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 FINDINGS:Active 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. CONCLUSIONS:Azithromycin 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 REGISTRATION:ClinicalTrials.gov NCT02048007. Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic PLOS Neglected Tropical Diseases 12 11 e0006950 |
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Open Polar |
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Directory of Open Access Journals: DOAJ Articles |
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ftdoajarticles |
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English |
topic |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
spellingShingle |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 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 Robin Bailey Travis C Porco Jeremy D Keenan Thomas M Lietman MORDOR Study Group Safety of azithromycin in infants under six months of age in Niger: A community randomized trial. |
topic_facet |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
description |
BACKGROUND:Mass 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 FINDINGS:Active 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. CONCLUSIONS:Azithromycin 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 REGISTRATION:ClinicalTrials.gov NCT02048007. |
format |
Article in Journal/Newspaper |
author |
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 Robin Bailey Travis C Porco Jeremy D Keenan Thomas M Lietman MORDOR Study Group |
author_facet |
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 Robin Bailey Travis C Porco Jeremy D Keenan Thomas M Lietman MORDOR Study Group |
author_sort |
Catherine E Oldenburg |
title |
Safety of azithromycin in infants under six months of age in Niger: A community randomized trial. |
title_short |
Safety of azithromycin in infants under six months of age in Niger: A community randomized trial. |
title_full |
Safety of azithromycin in infants under six months of age in Niger: A community randomized trial. |
title_fullStr |
Safety of azithromycin in infants under six months of age in Niger: A community randomized trial. |
title_full_unstemmed |
Safety of azithromycin in infants under six months of age in Niger: A community randomized trial. |
title_sort |
safety of azithromycin in infants under six months of age in niger: a community randomized trial. |
publisher |
Public Library of Science (PLoS) |
publishDate |
2018 |
url |
https://doi.org/10.1371/journal.pntd.0006950 https://doaj.org/article/0b30e3e60c88490781d3034b439ae38f |
geographic |
Arctic |
geographic_facet |
Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
PLoS Neglected Tropical Diseases, Vol 12, Iss 11, p e0006950 (2018) |
op_relation |
http://europepmc.org/articles/PMC6258425?pdf=render https://doaj.org/toc/1935-2727 https://doaj.org/toc/1935-2735 1935-2727 1935-2735 doi:10.1371/journal.pntd.0006950 https://doaj.org/article/0b30e3e60c88490781d3034b439ae38f |
op_doi |
https://doi.org/10.1371/journal.pntd.0006950 |
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PLOS Neglected Tropical Diseases |
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12 |
container_issue |
11 |
container_start_page |
e0006950 |
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