Table 1 Descriptions of clinical trials included in our study and from which interview participants were recruited
From: Ethical challenges in mass drug administration for reducing childhood mortality: a qualitative study
TRIAL | Description | Location | High child mortality country | Azithromycin used in study | Mortality outcome |
|---|---|---|---|---|---|
Mortality Reduction After Oral Azithromycin: Mortality Study (MORDOR) | A cluster-randomized trial with 3 sites comparing communities where children aged 1–59 months receive biannual oral azithromycin ("Azithromycin" arm) for two years, to communities where the children receive biannual oral placebo ("Control" arm) for two years in order to assess childhood mortality | Malawi Niger Tanzania | Yes (Niger) | Yes | Yes (Primary) |
Effects of Mass Drug Administration of Azithromycin on Mortality and Other Outcomes Among 1–11 Month Old Infants in Mali (LAKANA) | A cluster-randomized trial in Mali to assess the impact on mortality and other health outcomes of quarterly and biannual azithromycin mass drug administration (MDA) when delivered to 1–11-month old infants in a high-mortality setting where malaria is holoendemic but there is also a functioning seasonal malaria chemoprevention (SMC) program in place | Mali | Yes | Yes | Yes (Primary) |
Early Life Interventions for Childhood Growth and Development in Tanzania (ELICIT) | A randomized, 2 × 2 factorial, double-blind, placebo-controlled trial in the area around Haydom, Tanzania. Mother–child dyads were enrolled by age 14 days, randomized to 1 of 4 treatment arms, and followed with monthly home visits and every 3-month anthropometry assessments through 18 months. Primary outcome was length-for-age z-score (LAZ) at 18 months in the modified intention-to-treat group | Tanzania | No | Yes | Yes (Secondary) |
Azithromycin—Ivermectin Mass Drug Administration for Skin Disease (AIM-Skin) | An open-label prospective community intervention trial to assess the impact of community mass treatment with azithromycin for yaws and ivermectin for scabies, on non-yaws bacterial skin infections. Communities were randomized to receive standard treatment for both yaws and scabies either in parallel (site 1) or in sequence (site 2). Primary outcome was the difference in the change in prevalence of impetigo between baseline and 12-months between the parallel and the sequential treatment arms | Solomon Islands | No | Yes | No |
A Trial of Seasonal Malaria Chemoprevention Plus Azithromycin in African Children (SMCAZ) | A randomized, placebo-controlled trial in the Hounde district of Burkina Faso and the Bougouni district of Mali. Children aged 3–59 months were randomized to receive four cycles of either SMC and azithromycin or SMC and placebo at monthly intervals during peak malaria transmission season. Primary outcome was the incidence of the combination of death or hospital admission for at least 24 h, not due to trauma or elective surgery during the intervention period | Burkina Faso Mali | Yes | Yes | Yes (Primary) |
Nutritional Support for Lactating Women and Azithromycin to Infants—Mumta Lactating Women Trial (MumtaLW) | A community-based, randomized control trial in peri-urban settings of Karachi, Pakistan to study the impact of lipid-based nutritional supplement for pregnant and lactating women (LW) and single prophylaxis dose of azithromycin for infants on growth (length velocity) of infants over the period of six months since birth compared to current standard of care. LW and her infant are enrolled in the trial within 168 h of birth and will be randomized to one of three study arms: standard of care (control), nutritional supplement only, or nutritional supplement plus azithromycin | Pakistan | No | Yes | No |
The Effect of Routine Antibiotic Use in the Outpatient Treatment of Severely Malnourished Children Without Complications | A randomized, placebo-controlled trial to compare routine antibiotic prescription vs no routine antibiotic prescription in the management of uncomplicated cases of severe acute malnutrition treated in a community in Niger in terms of nutritional recovery. Children aged 6–59 months received either routine amoxicillin prescription for 7 days (80 mg/kg/day) or placebo. Primary outcome was proportion of children discharged from nutritional program as recovered | Niger | Yes | No | Yes (Secondary) |