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Azithromycin for infants at risk of poor growth and development: A pooled secondary analysis of two randomized
Mamadou Bountogo1, Mamadou Ouattara1, Clarisse Dah1
1Centre de Recherche en Santé de Nouna, Burkina Faso.
Insights
A single dose of azithromycin did not reduce mortality or wasting in infants at risk of poor growth. This study evaluated azithromycin
Area of Science:
- Pediatrics
- Infectious Diseases
- Global Health
Background:
- The World Health Organization (WHO) revised severe acute malnutrition (SAM) guidelines in 2023, emphasizing infants at risk of poor growth.
- Routine antibiotic use for these infants is a priority research area for improving infant outcomes.
Purpose of the Study:
- To assess the impact of azithromycin on infant mortality and wasting.
- To evaluate azithromycin's effectiveness in preventing poor growth outcomes in high-risk infants.
Main Methods:
- Pooled data from two randomized controlled trials in Burkina Faso involving 54,709 infants aged 1-12 weeks.
- Infants identified as at-risk based on WHO criteria (low weight-for-age, weight-for-length, or MUAC) received a single oral dose of azithromycin or placebo.
- Outcomes including mortality, underweight, wasting, and stunting were assessed at 6 months of age.
Main Results:
- A total of 9,728 infants met the criteria for being at risk of poor growth.
- No significant difference in mortality (1.3% vs. 1.1%) or wasting (20.6% vs. 20.2%) was observed at 6 months between the azithromycin and placebo groups.
- Statistical analysis showed no evidence of benefit from azithromycin in this subgroup.
Conclusions:
- Single-dose azithromycin administered to infants aged 1-12 weeks at risk of poor growth does not reduce mortality.
- Azithromycin did not demonstrate improved growth outcomes, such as reduced wasting, in this vulnerable infant population.
Background:
In 2023, the World Health Organization (WHO) revised its guidelines for management of severe acute malnutrition (SAM). The revised guidelines include a focus on infants at risk of poor growth and development. The guideline identifies evaluation of routine antibiotics for these infants as a priority research area.
Objective:
We pooled data from two large randomized controlled trials evaluating azithromycin for prevention of infant mortality in Burkina Faso to assess whether azithromycin reduces mortality or wasting in this subgroup.
Methods:
Infants in the two trials were 1-12 weeks of age at enrollment. Infants were considered at risk of poor risk of growth and development per WHO: underweight (weight-for-age Z-score, WAZ < -2), wasted (weight-for-length Z-score, WLZ < -2), or MUAC < 11.0 cm among infants ≥6 weeks of age. Infants were randomized to a single oral (20 mg/kg) dose of azithromycin or matching placebo and were followed until 6 months of age. We evaluated vital status, underweight (WAZ < -2), wasting (WLZ < -2), and stunting (length-for-age Z-score, LAZ) at 6 months among infants at risk of poor growth and development based on WHO single measurement criteria.
Results:
A total of 54,709 infants were enrolled in the two trials. Of these, 9,728 were at risk of poor growth and development based on baseline WAZ (N = 5,385), WLZ (N = 6,022), or MUAC (N = 1,541). We found no evidence of a difference in mortality (1.3% vs 1.1%, odds ratio, OR, 1.19, 95% confidence interval, CI, 0.82 to 1.72) or wasting (20.6% vs 20.2%, OR 1.03, 95% CI 0.92 to 1.14) at 6 months among infants receiving azithromycin versus placebo.
Conclusions:
In infants aged 1-12 weeks at risk of poor growth and development, we do not have evidence that single dose azithromycin reduces mortality or improves growth outcomes.
Trial Registration:
ClinicalTrials.gov NCT03682654 and NCT03676764.
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