Last Updated: 01/09/2025

A trial of the benefit of including azithromycin in the drug combination used for seasonal malaria chemoprevention in African children (SMCAZ)

Objectives

The primary objective of this study is to determine whether addition of azithromycin (AZ) to Seasonal Malaria Chemoprevention (SMC) using sulphadoxine/pyrimethamine plus amodiaquine (SP+AQ) will reduce severe illness / death (as defined below) in young African children resident in areas where malaria transmission is highly seasonal.

Secondary objectives include an assessment of the safety and cost-effectiveness of the addition of AZ to SMC with SP+AQ.

Principal Institution

London School of Hygiene and Tropical Medicine (LSHTM), United Kingdom

Principal Investigators / Focal Persons

Brian Greenwood
Daniel Chandramohan

Partner Institutions

Research Institute of Health Sciences (IRSS), Burkina Faso

Rationale and Abstract

Good progress is being made in controlling malaria in Africa but success has been only partial. In some countries there has been only a modest decline in the incidence of malaria despite the widespread deployment of insecticide-treated bed nets, spraying of the inside of houses with insecticide and treatment of clinical cases with highly effective drug combinations based on compounds derived from the plant Artemisia annua. More efforts need to be made to scale up these interventions but additional control tools are needed.

One potential new tool is seasonal malaria chemoprevention (SMC). SMC involves the administration of a treatment dose of an effective antimalarial drug combination to all children at risk during a period of maximum risk of infection. This approach to malaria control is targeted specifically at areas where malaria transmission is limited by climatic factors to only a few months of the year so that drugs do not have to be given on more than three or four occasions. Areas where SMC would be an appropriate intervention include most of the Sahel and sub-Sahel (population approximately 200 million). Studies conducted in areas of seasonal malaria transmission have shown that SMC with the combination of sulphadoxine/pyrimethamine (SP) and amodiaquine (AQ) reduced the incidence of severe and uncomplicated malaria by over 70% and probably reduced deaths.

ClinicalTrials.gov Identifier: NCT02211729

This trial was conducted after the surprising findings from the Partnership for the Rapid Elimination of Trachoma (PRET) trial, where a 49% reduction in all-cause mortality among children 1 to 9 years of age during the year after mass administration of a single dose of azithromycin — a reduction that was sustained during a 26-month follow-up period — was seen in Ethiopia.

Study Design

Study Type :	Interventional (Clinical Trial)
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Prevention