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Azithromycin for uncomplicated severe acute malnutrition: study protocol for a pilot randomized controlled trial
Kieran S O'Brien1, Ali Sié2, Clarisse Dah2
1Francis I Proctor Foundation, University of California, San Francisco, 490 Illinois St, San Francisco, CA, USA.
Insights
This pilot study compares azithromycin and amoxicillin for treating severe acute malnutrition (SAM) in children. It assesses feasibility and preliminary evidence for azithromycin
Area of Science:
- Pediatrics
- Infectious Diseases
- Nutritional Science
Background:
- Children with severe acute malnutrition (SAM) face high infectious mortality risks.
- Amoxicillin is recommended for SAM, but its efficacy in improving nutritional recovery or reducing mortality is debated.
- Azithromycin, with a long half-life and proven efficacy in high-risk groups, is a potential alternative antibiotic for SAM management.
Purpose of the Study:
- To compare the efficacy of azithromycin versus amoxicillin in improving nutritional outcomes for children with uncomplicated SAM.
- To establish the feasibility of conducting a full-scale randomized controlled trial (RCT) for evaluating alternative antibiotics in this population.
- To provide preliminary evidence on azithromycin's effectiveness compared to amoxicillin in children with SAM.
Main Methods:
- A pilot randomized controlled trial involving 300 children with uncomplicated SAM in Burkina Faso.
- Children were randomized to receive either a single dose of oral azithromycin or a 7-day course of oral amoxicillin, alongside standard care.
- Outcomes monitored weekly included anthropometric indicators, vital status, and clinical outcomes, with a primary clinical endpoint of weight gain over 8 weeks.
Main Results:
- Primary feasibility outcomes such as enrollment rates, refusals, loss to follow-up, and data completeness were assessed.
- The study's primary clinical outcome was weight gain (g/kg/day) over the 8-week study period.
- Preliminary clinical efficacy data for azithromycin versus amoxicillin was collected.
Conclusions:
- The pilot trial successfully determined the feasibility of a larger RCT evaluating antibiotic alternatives for SAM.
- Preliminary evidence suggests azithromycin's potential efficacy in improving nutritional outcomes for children with SAM compared to amoxicillin.
- Further research is warranted to confirm these findings in a full-scale 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 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 ).
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