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Abstract
BackgroundThe MORDOR study, a cluster randomized clinical trial, showed that single-dose azithromycin (20 mg/kg) administered biannually for 2 years to preschool children reduced mortality; a study was conducted to determine its effect on clinical symptomatic episodes of malaria as a potential mechanism for mortality benefit.MethodsA randomized control trial (RCT) was conducted, whereby 30 randomly selected communities in Kilosa District, Tanzania were randomized to receive 6-monthly treatment of children ages 1–59 months with single-dose azithromycin (20 mg/kg) vs. placebo. A prospective cohort study was nested within the RCT: children, aged 1 to 35 months at baseline, were randomly selected in each community and evaluated at 6-monthly intervals for 2 years. At each visit, the children were assessed for recent or ongoing fever and anti-malarial treatment; a rapid diagnostic test (RDT) for malaria was performed. The two major outcomes of interest were prevalence of RDT positivity and clinical malaria. The latter was defined as RDT-positivity with fever at time of evaluation and/or reported fever in the 3 days prior to evaluation. Methods that account for correlations at community level and within individuals over time were used to evaluate associations.ResultsAt baseline, the prevalence rates in the children in the azithromycin and placebo arms were 17.6% vs. 15.5% for RDT positivity (p = 0.76) and 6.1% vs. 4.3% (p = 0.56) for clinical malaria. There was a decline in both RDT-positivity and clinical malaria over time in both arms. The difference by treatment assignment was not significant for clinical malaria; it was significant for RDT-positivity with greater odds of decline in the placebo arm (p = 0.01).ConclusionsLack of evidence for a significant difference in the prevalence of clinical malaria in children at any visit following treatment suggests that the effect of single-dose azithromycin on malaria is at best transient and limited in scope. Chance overrepresentation of non-seasonal transmission in the communities in the azithromycin arm may account for higher rates of RDT-positivity and less decline over time.Trial registration Clinicaltrials.gov NCT02047981
Highlights
The MORDOR study, a cluster randomized clinical trial, showed that single-dose azithromycin (20 mg/ kg) administered biannually for 2 years to preschool children reduced mortality; a study was conducted to determine its effect on clinical symptomatic episodes of malaria as a potential mechanism for mortality benefit
The MORDOR study, a multinational cluster randomized clinical trial found that biannual mass treatment of preschool children with azithromycin, was associated with a reduction in all-cause mortality [1]
While azithromycin monotherapy is not recommended as treatment [11], it may be viable in combination with other anti-malarials [9]
Summary
The MORDOR study, a cluster randomized clinical trial, showed that single-dose azithromycin (20 mg/ kg) administered biannually for 2 years to preschool children reduced mortality; a study was conducted to determine its effect on clinical symptomatic episodes of malaria as a potential mechanism for mortality benefit. The MORDOR study, a multinational cluster randomized clinical trial found that biannual mass treatment of preschool children with azithromycin, was associated with a reduction in all-cause mortality [1]. Azithromycin has been shown to be effective against protozoal infections: azithromycin—in combination with atovaquone— is the mainstay of therapy for babesiosis [4, 5]. It has demonstrated moderate efficacy against malaria in laboratory [6,7,8] and clinical studies [9,10,11] alike. Longitudinal studies of mass drug administration (MDA) of azithromycin have suggested azithromycin’s protective effect to be evident for only a short time for respiratory [12], diarrhoeal disease [13], and malaria parasitaemia [14], which are the major causes of childhood deaths in low-income countries [15]
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