Safety of azithromycin in infants under six months of age in Niger: A community randomized trial.
PLoS Negl Trop Dis
; 12(11): e0006950, 2018 11.
Article
en En
| MEDLINE
| ID: mdl-30419040
ABSTRACT
BACKGROUND:
Mass azithromycin distribution reduces under-5 child mortality. Trachoma control programs currently treat infants aged 6 months and older. Here, we report findings from an infant adverse event survey in 1-5 month olds who received azithromycin as part of a large community-randomized trial in Niger. METHODS AND PRINCIPALFINDINGS:
Active surveillance of infants aged 1-5 months at the time of treatment was conducted in 30 randomly selected communities from within a large cluster randomized trial of biannual mass azithromycin distribution compared to placebo to assess the potential impact on child mortality. We compared the distribution of adverse events reported after treatment among azithromycin-treated versus placebo-treated infants. From January 2015 to February 2018, the caregivers of 1,712 infants were surveyed. Approximately one-third of caregivers reported at least one adverse event (azithromycin 29.6%, placebo 34.3%, risk ratio [RR] 0.86, 95% confidence interval [CI] 0.68 to 1.10, P = 0.23). The most commonly reported adverse events included diarrhea (azithromycin 19.3%, placebo 28.1%, RR 0.68, 95% CI 0.49 to 0.96, P = 0.03), vomiting (azithromycin 15.9%, placebo 21.0%, RR 0.76, 95% CI 0.56 to 1.02, P = 0.07), and skin rash (azithromycin 12.3%, placebo 13.6%, RR 0.90, 95% CI 0.59 to 1.37, P = 0.63). No cases of infantile hypertrophic pyloric stenosis were reported.CONCLUSIONS:
Azithromycin given to infants aged 1-5 months appeared to be safe. Inclusion of younger infants in larger azithromycin-based child mortality or trachoma control programs could be considered if deemed effective. TRIAL REGISTRATION ClinicalTrials.gov NCT02048007.
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Chlamydia trachomatis
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Tracoma
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Azitromicina
/
Antibacterianos
Tipo de estudio:
Clinical_trials
Límite:
Female
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Humans
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Infant
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Male
País/Región como asunto:
Africa
Idioma:
En
Revista:
PLoS Negl Trop Dis
Asunto de la revista:
MEDICINA TROPICAL
Año:
2018
Tipo del documento:
Article
País de afiliación:
Estados Unidos