Azithromycin for uncomplicated severe acute malnutrition: study protocol for a pilot randomized controlled trial.
Amoxicillin
Azithromycin
Severe acute malnutrition
Weight gain
Journal
Pilot and feasibility studies
ISSN: 2055-5784
Titre abrégé: Pilot Feasibility Stud
Pays: England
ID NLM: 101676536
Informations de publication
Date de publication:
20 Apr 2021
20 Apr 2021
Historique:
received:
29
11
2020
accepted:
10
04
2021
entrez:
21
4
2021
pubmed:
22
4
2021
medline:
22
4
2021
Statut:
epublish
Résumé
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. 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. 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. This trial was first registered on clinicaltrials.gov on 26 June 2018 ( NCT03568643 ).
Sections du résumé
BACKGROUND
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
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
CONCLUSIONS
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
BACKGROUND
This trial was first registered on clinicaltrials.gov on 26 June 2018 ( NCT03568643 ).
Identifiants
pubmed: 33879263
doi: 10.1186/s40814-021-00836-w
pii: 10.1186/s40814-021-00836-w
pmc: PMC8056624
doi:
Banques de données
ClinicalTrials.gov
['NCT03568643']
Types de publication
Journal Article
Langues
eng
Pagination
97Subventions
Organisme : NICHD NIH HHS
ID : R21 HD100932
Pays : United States
Organisme : University of California San Francisco
ID : NA
Organisme : National Institute of Child Health and Human Development
ID : 1R21HD100932
Références
PLoS Med. 2020 Sep 15;17(9):e1003285
pubmed: 32931496
N Engl J Med. 2018 Apr 26;378(17):1583-1592
pubmed: 29694816
Am J Trop Med Hyg. 2020 Sep;103(3):1308-1310
pubmed: 32067626
Am J Trop Med Hyg. 2020 Sep;103(3):1291-1294
pubmed: 30734695
Lancet Glob Health. 2020 Feb;8(2):e288-e295
pubmed: 31981558
N Engl J Med. 2013 Jan 31;368(5):425-35
pubmed: 23363496
N Engl J Med. 2019 Jun 06;380(23):2207-2214
pubmed: 31167050
Lancet Glob Health. 2016 Jul;4(7):e464-73
pubmed: 27265353
N Engl J Med. 2016 Feb 4;374(5):444-53
pubmed: 26840134
PLoS Med. 2019 Jun 25;16(6):e1002835
pubmed: 31237871
Am J Epidemiol. 2003 May 15;157(10):940-3
pubmed: 12746247
Am J Epidemiol. 2004 Apr 1;159(7):702-6
pubmed: 15033648
PLoS One. 2013 Jul 17;8(7):e68699
pubmed: 23874731