Safety and Antimicrobial Resistance of Mass Administration of Azithromycin in Children in Nigeria (SARMAAN)

Summary

This study is part of a ‘portfolio’ of research, under the Resiliency through Azithromycin for Children (REACH) Network, with a goal to reduce infant mortality through phased roll-out of azithromycin mass drug administration (MDA) to areas in target countries where the infant mortality rate is higher than 60 per 1,000 live births.

With leadership from the Nigerian Institute of Medical Research, this study tests the operationalisation of the World Health Organization (WHO) guideline on the MDA of azithromycin to children under five years of age to promote child survival.

Recommendation 2 in the WHO guideline reads: “WHO recommends that consideration be given to MDA of azithromycin to children 1 to 11 months of age for prevention of childhood mortality in sub-Saharan African settings in which: infant mortality is > 60 per 1000 live births or under-five mortality is > 80 per 1,000 live births respectively, and infant and under-five mortality rates, adverse effects and antibiotic resistance (AMR) are continuously monitored, and implementation of existing child survival interventions, including seasonal malaria chemoprophylaxis where recommended, is concurrently strengthened.”

Phase 1 funding
The study was funded by a consortium of donors to Sightsavers’ Accelerate programme, including Gates Foundation, Children’s Investment Fund Foundation, The ELMA Foundation, Virgin Unite and an anonymous donor. The azithromycin Powder for Oral Suspension was donated by Pfizer.

Phase 2 funding
Gates Foundation

Objectives

Phase 1 – States: Abia, Akwa Ibom, Kano, Jigawa, Kebbi and Sokoto:

To determine the effect of mass administration of azithromycin among children aged one to 11 months old on the safety and pattern of antimicrobial resistance in all project sites
To determine the cost, cost-effectiveness, feasibility and acceptability of delivering azithromycin across platforms, neglected tropical diseases (NTDs); Seasonal Malaria Chemoprophylaxis (SMC); and National Program on Immunization (NPI)

Phase 2 – States: Sokoto and Kano (Sightsavers). Support from other partners in Kano, Katsina, Kebbi, Kaduna, Jigawa and Bauchi:

To evaluate the coverage and equity of mass administration of azithromycin (REACH)
To evaluate the child health outcome (mortality and morbidity) among children aged one to 59 months over the study period
To determine the antimicrobial resistance and safety of azithromycin MDA in children aged one to 59 months (effectiveness)
To determine factors influencing implementer readiness to adopt azithromycin MDA as a policy (adoption)
To explore and understand the implementation processes, challenges and successes of azithromycin MDA when co-administered with other child survival strategies across all project sites (implementation)
To establish best practices for monitoring the safety and antimicrobial resistance of azithromycin MDA at scale within routine settings (maintenance)

Policy and practice implications

The outcome of this study will help to guide policy and implementation on the mass administration of azithromycin for the purpose of improving child survival in Nigeria and other settings with high infant and under five mortality.