Causes of death after biannual azithromycin treatment: A community-level randomized clinical trial.

The MORDOR study, a masked, community-level randomized clinical trial conducted in Niger, Malawi and Tanzania (2015 to 2017), showed that biannual administration of single-dose azithromycin to preschool children reduced all-cause mortality. We sought to evaluate its impact on causes of death in chil...

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Autores principales:	Evan M Bloch, Zakayo Mrango, Jerusha Weaver, Beatriz Munoz, Thomas M Lietman, Sheila K West
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/9c7235699cbf4cab909e8dc7b58e8b51
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spelling	oai:doaj.org-article:9c7235699cbf4cab909e8dc7b58e8b512021-12-02T20:08:02ZCauses of death after biannual azithromycin treatment: A community-level randomized clinical trial.1932-620310.1371/journal.pone.0250197https://doaj.org/article/9c7235699cbf4cab909e8dc7b58e8b512021-01-01T00:00:00Zhttps://doi.org/10.1371/journal.pone.0250197https://doaj.org/toc/1932-6203The MORDOR study, a masked, community-level randomized clinical trial conducted in Niger, Malawi and Tanzania (2015 to 2017), showed that biannual administration of single-dose azithromycin to preschool children reduced all-cause mortality. We sought to evaluate its impact on causes of death in children aged 1-59 months in Tanzania. A random sampling of 614 communities was conducted in Kilosa District, Tanzania, with simple random assignment of communities to receive either azithromycin or placebo. In these communities, a census was carried out every 6 months and children aged 1-59 months received biannual (every 6 months), single-dose azithromycin (~20mg/kg) or placebo depending on community assignment, over a 2-year period. Mortality was determined at the time of the biannual census. For child deaths, a verbal autopsy was performed to ascertain the cause using a standardized diagnostic classification. A total of 190- (0.58 /100 person-years) and 200 deaths (0.59/100 person-years) were reported in the azithromycin and placebo arms, respectively. Malaria, pneumonia and diarrhea, accounted for 71% and 68% of deaths in the respective arms. Overall, the mortality was not different by treatment arm, nor were the distribution of causes of death after adjusting for community clustering. The cause-specific mortality for diarrhea/pneumonia was no different over time. In children aged 1-5 months, 32 deaths occurred in the placebo arm and 25 deaths occurred in the azithromycin arm; 20 (62.5%) deaths in the placebo- and 10 (40%) in the azithromycin arm were attributed to diarrhea or pneumonia. Neither differences in the number of deaths nor the diarrhea/pneumonia attribution was statistically significant after adjusting for community clustering. In conclusion, azithromycin was not associated with a significant decline in deaths by specific causes compared to placebo. The non-significant lower rates of diarrhea or pneumonia in children <6 months who received azithromycin merit further investigation in high-mortality settings. Trial registration: NCT02048007.Evan M BlochZakayo MrangoJerusha WeaverBeatriz MunozThomas M LietmanSheila K WestPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 16, Iss 9, p e0250197 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Evan M Bloch Zakayo Mrango Jerusha Weaver Beatriz Munoz Thomas M Lietman Sheila K West Causes of death after biannual azithromycin treatment: A community-level randomized clinical trial.
description	The MORDOR study, a masked, community-level randomized clinical trial conducted in Niger, Malawi and Tanzania (2015 to 2017), showed that biannual administration of single-dose azithromycin to preschool children reduced all-cause mortality. We sought to evaluate its impact on causes of death in children aged 1-59 months in Tanzania. A random sampling of 614 communities was conducted in Kilosa District, Tanzania, with simple random assignment of communities to receive either azithromycin or placebo. In these communities, a census was carried out every 6 months and children aged 1-59 months received biannual (every 6 months), single-dose azithromycin (~20mg/kg) or placebo depending on community assignment, over a 2-year period. Mortality was determined at the time of the biannual census. For child deaths, a verbal autopsy was performed to ascertain the cause using a standardized diagnostic classification. A total of 190- (0.58 /100 person-years) and 200 deaths (0.59/100 person-years) were reported in the azithromycin and placebo arms, respectively. Malaria, pneumonia and diarrhea, accounted for 71% and 68% of deaths in the respective arms. Overall, the mortality was not different by treatment arm, nor were the distribution of causes of death after adjusting for community clustering. The cause-specific mortality for diarrhea/pneumonia was no different over time. In children aged 1-5 months, 32 deaths occurred in the placebo arm and 25 deaths occurred in the azithromycin arm; 20 (62.5%) deaths in the placebo- and 10 (40%) in the azithromycin arm were attributed to diarrhea or pneumonia. Neither differences in the number of deaths nor the diarrhea/pneumonia attribution was statistically significant after adjusting for community clustering. In conclusion, azithromycin was not associated with a significant decline in deaths by specific causes compared to placebo. The non-significant lower rates of diarrhea or pneumonia in children <6 months who received azithromycin merit further investigation in high-mortality settings. Trial registration: NCT02048007.
format	article
author	Evan M Bloch Zakayo Mrango Jerusha Weaver Beatriz Munoz Thomas M Lietman Sheila K West
author_facet	Evan M Bloch Zakayo Mrango Jerusha Weaver Beatriz Munoz Thomas M Lietman Sheila K West
author_sort	Evan M Bloch
title	Causes of death after biannual azithromycin treatment: A community-level randomized clinical trial.
title_short	Causes of death after biannual azithromycin treatment: A community-level randomized clinical trial.
title_full	Causes of death after biannual azithromycin treatment: A community-level randomized clinical trial.
title_fullStr	Causes of death after biannual azithromycin treatment: A community-level randomized clinical trial.
title_full_unstemmed	Causes of death after biannual azithromycin treatment: A community-level randomized clinical trial.
title_sort	causes of death after biannual azithromycin treatment: a community-level randomized clinical trial.
publisher	Public Library of Science (PLoS)
publishDate	2021
url	https://doaj.org/article/9c7235699cbf4cab909e8dc7b58e8b51
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Causes of death after biannual azithromycin treatment: A community-level randomized clinical trial.

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