Abstract
BackgroundAzithromycin has recently been shown to reduce all-cause childhood mortality in sub-Saharan Africa. One potential mechanism of this effect is via the anti-malarial effect of azithromycin, which may help treat or prevent malaria infection. This study evaluated short- and longer-term effects of azithromycin on malaria outcomes in children.MethodsChildren aged 8 days to 59 months were randomized in a 1:1 fashion to a single oral dose of azithromycin (20 mg/kg) or matching placebo. Children were evaluated for malaria via thin and thick smear and rapid diagnostic test (for those with tympanic temperature ≥ 37.5 °C) at baseline and 14 days and 6 months after treatment. Malaria outcomes in children receiving azithromycin versus placebo were compared at each follow-up timepoint separately.ResultsOf 450 children enrolled, 230 were randomized to azithromycin and 220 to placebo. Children were a median of 26 months and 51% were female, and 17% were positive for malaria parasitaemia at baseline. There was no evidence of a difference in malaria parasitaemia at 14 days or 6 months after treatment. In the azithromycin arm, 20% of children were positive for parasitaemia at 14 days compared to 17% in the placebo arm (P = 0.43) and 7.6% vs. 5.6% in the azithromycin compared to placebo arms at 6 months (P = 0.47).ConclusionsAzithromycin did not affect malaria outcomes in this study, possibly due to the individually randomized nature of the trial.Trial registration This study is registered at clinicaltrials.gov (NCT03676751; registered 19 September 2018).
Highlights
Azithromycin has recently been shown to reduce all-cause childhood mortality in sub-Saharan Africa
Malaria parasitaemia was balanced between treatment groups at baseline prior to study treatment and was present in 18 and 16% of children in the azithromycin and placebo groups
Malaria parasitaemia declined from baseline to 6 months in in both study arms (Fig. 2), as expected since the 6-month visit was conducted in June prior to the beginning of the high malaria transmission season
Summary
Azithromycin has recently been shown to reduce all-cause childhood mortality in sub-Saharan Africa. Biannual mass azithromycin distribution with a single oral 20 mg/kg dose has been shown to reduce all-cause childhood mortality in settings with high malaria transmission [1]. In this same study, azithromycin was shown. Prevention or treatment of existing malaria infection may be one mechanism of any effect of single dose oral azithromycin on all-cause childhood mortality, where malaria is an important cause of child mortality. This individually randomized trial of single oral azithromycin compared to matching placebo was designed to elucidate potential mechanisms of any effect of azithromycin on mortality in Nouna, Burkina Faso. A pre-specified secondary analysis of the trial evaluated the effect of single dose azithromycin on malaria parasitaemia administered at the end of the high malaria transmission season in a region with predominantly Plasmodium falciparum malaria
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