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Azithromycin for uncomplicated severe acute malnutrition: study protocol for a pilot randomized controlled trial
BACKGROUND: Given the high risk of infectious mortality among children with severe acute malnutrition (SAM), the World Health Organization recommends routine administration of a broad-spectrum antibiotic like amoxicillin as part of the management of uncomplicated SAM. However, evidence for the effic...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BioMed Central
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8056624/ https://www.ncbi.nlm.nih.gov/pubmed/33879263 http://dx.doi.org/10.1186/s40814-021-00836-w |
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author | O’Brien, Kieran S. Sié, Ali Dah, Clarisse Ourohire, Millogo Arzika, Ahmed M. Boudo, Valentin Lebas, Elodie Godwin, William W. Arnold, Benjamin F. Oldenburg, Catherine E. |
author_facet | O’Brien, Kieran S. Sié, Ali Dah, Clarisse Ourohire, Millogo Arzika, Ahmed M. Boudo, Valentin Lebas, Elodie Godwin, William W. Arnold, Benjamin F. Oldenburg, Catherine E. |
author_sort | O’Brien, Kieran S. |
collection | PubMed |
description | BACKGROUND: Given the high risk of infectious mortality among children with severe acute malnutrition (SAM), the World Health Organization recommends routine administration of a broad-spectrum antibiotic like amoxicillin as part of the management of uncomplicated SAM. However, evidence for the efficacy of amoxicillin to improve nutritional recovery or reduce mortality has been mixed. With a long half-life and evidence of efficacy to reduce mortality in high-risk populations, azithromycin is a potential alternative to amoxicillin in the management of SAM. In this pilot study, we aim to compare the efficacy of azithromycin to amoxicillin to improve nutritional outcomes in children with uncomplicated SAM. METHODS: This pilot randomized controlled trial will enroll 300 children with uncomplicated SAM from 6 Centre de Santé et de Promotion Sociale in the Boromo health district in Burkina Faso. Eligible children are randomized to receive a single directly observed dose of oral azithromycin or a 7-day course of oral amoxicillin in addition to the standard package of care for uncomplicated SAM. Enrolled children are followed weekly until nutritional recovery, and all children return for a final study visit at 8 weeks after enrollment. Anthropometric indicators, vital status, and clinical outcomes are monitored at each visit and compared by arm. Primary feasibility outcomes include enrollment potential, refusals, loss to follow-up, and completeness of data collection. The primary clinical outcome is weight gain (g/kg/day) over the 8-week study period. DISCUSSION: This pilot trial will establish the feasibility of conducting a full-scale randomized controlled trial to evaluate alternative antibiotics in this setting and provide preliminary evidence for the efficacy of azithromycin compared to amoxicillin to improve outcomes for children with SAM. TRIAL REGISTRATION: This trial was first registered on clinicaltrials.gov on 26 June 2018 (NCT03568643). |
format | Online Article Text |
id | pubmed-8056624 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-80566242021-04-20 Azithromycin for uncomplicated severe acute malnutrition: study protocol for a pilot randomized controlled trial O’Brien, Kieran S. Sié, Ali Dah, Clarisse Ourohire, Millogo Arzika, Ahmed M. Boudo, Valentin Lebas, Elodie Godwin, William W. Arnold, Benjamin F. Oldenburg, Catherine E. Pilot Feasibility Stud Study Protocol BACKGROUND: Given the high risk of infectious mortality among children with severe acute malnutrition (SAM), the World Health Organization recommends routine administration of a broad-spectrum antibiotic like amoxicillin as part of the management of uncomplicated SAM. However, evidence for the efficacy of amoxicillin to improve nutritional recovery or reduce mortality has been mixed. With a long half-life and evidence of efficacy to reduce mortality in high-risk populations, azithromycin is a potential alternative to amoxicillin in the management of SAM. In this pilot study, we aim to compare the efficacy of azithromycin to amoxicillin to improve nutritional outcomes in children with uncomplicated SAM. METHODS: This pilot randomized controlled trial will enroll 300 children with uncomplicated SAM from 6 Centre de Santé et de Promotion Sociale in the Boromo health district in Burkina Faso. Eligible children are randomized to receive a single directly observed dose of oral azithromycin or a 7-day course of oral amoxicillin in addition to the standard package of care for uncomplicated SAM. Enrolled children are followed weekly until nutritional recovery, and all children return for a final study visit at 8 weeks after enrollment. Anthropometric indicators, vital status, and clinical outcomes are monitored at each visit and compared by arm. Primary feasibility outcomes include enrollment potential, refusals, loss to follow-up, and completeness of data collection. The primary clinical outcome is weight gain (g/kg/day) over the 8-week study period. DISCUSSION: This pilot trial will establish the feasibility of conducting a full-scale randomized controlled trial to evaluate alternative antibiotics in this setting and provide preliminary evidence for the efficacy of azithromycin compared to amoxicillin to improve outcomes for children with SAM. TRIAL REGISTRATION: This trial was first registered on clinicaltrials.gov on 26 June 2018 (NCT03568643). BioMed Central 2021-04-20 /pmc/articles/PMC8056624/ /pubmed/33879263 http://dx.doi.org/10.1186/s40814-021-00836-w Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Study Protocol O’Brien, Kieran S. Sié, Ali Dah, Clarisse Ourohire, Millogo Arzika, Ahmed M. Boudo, Valentin Lebas, Elodie Godwin, William W. Arnold, Benjamin F. Oldenburg, Catherine E. Azithromycin for uncomplicated severe acute malnutrition: study protocol for a pilot randomized controlled trial |
title | Azithromycin for uncomplicated severe acute malnutrition: study protocol for a pilot randomized controlled trial |
title_full | Azithromycin for uncomplicated severe acute malnutrition: study protocol for a pilot randomized controlled trial |
title_fullStr | Azithromycin for uncomplicated severe acute malnutrition: study protocol for a pilot randomized controlled trial |
title_full_unstemmed | Azithromycin for uncomplicated severe acute malnutrition: study protocol for a pilot randomized controlled trial |
title_short | Azithromycin for uncomplicated severe acute malnutrition: study protocol for a pilot randomized controlled trial |
title_sort | azithromycin for uncomplicated severe acute malnutrition: study protocol for a pilot randomized controlled trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8056624/ https://www.ncbi.nlm.nih.gov/pubmed/33879263 http://dx.doi.org/10.1186/s40814-021-00836-w |
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