Safety of azithromycin in infants under six months of age in Niger: A community randomized trial.

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 PRINCIPAL FINDINGS: 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.

'A living death': a qualitative assessment of quality of life among women with trichiasis in rural Niger.

BACKGROUND: Prior to blindness, trachoma is thought to profoundly affect women's abilities to lead normal lives, but supporting evidence is lacking. To better understand the effects of trichiasis, we asked women to define quality of life, how trichiasis affects this idea and their perceptions of eyelid surgery. METHODS: Operated and unoperated women were purposively selected for in-depth interviews. These were audio-recorded and transcribed, and codes were identified and applied to the transcripts. Overarching themes, commonalities and differences were identified and matched to quotations. RESULTS: Twenty-three women were interviewed. Quality of life was defined as health, security, family, social status and religious participation. Trichiasis caused severe pain and loss of health, leading to loss of security. This affected social, economic and religious activities and caused burden on their families. Surgery improved quality of life, even in cases of surgical failure or recurrent disease. CONCLUSIONS: Trichiasis disables most women, even those reporting fewer or less-severe symptoms. While women in rural Niger often live in extreme poverty, trichiasis exacerbates the situation, making women unable to work and undermining their social status. It adds to family burden, as women lose the ability to meaningfully contribute to the household and require additional family resources for their care.