Effect of a single dose of oral azithromycin on malaria parasitaemia in children: a randomized controlled trial

Boubacar Coulibaly, Ali Sié, Clarisse Dah, Mamadou Bountogo, Mamadou Ouattara, Adama Compaoré, Moustapha Nikiema, Jérôme Nankoné Tiansi, Nestor Dembélé Sibiri, Jessica M Brogdon, Elodie Lebas, Thuy Doan, Travis C Porco, Thomas M Lietman, Catherine E Oldenburg, Boubacar Coulibaly, Ali Sié, Clarisse Dah, Mamadou Bountogo, Mamadou Ouattara, Adama Compaoré, Moustapha Nikiema, Jérôme Nankoné Tiansi, Nestor Dembélé Sibiri, Jessica M Brogdon, Elodie Lebas, Thuy Doan, Travis C Porco, Thomas M Lietman, Catherine E Oldenburg

Abstract

Background: Azithromycin 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.

Methods: Children 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.

Results: Of 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).

Conclusions: Azithromycin 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).

Keywords: Azithromycin; Burkina Faso; Malaria; Randomized controlled trial.

Conflict of interest statement

The authors declare no competing interests.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
CONSORT flow diagram of study participants
Fig. 2
Fig. 2
Malaria parasitaemia prevalence (A) and parasite density in parasites/µl (restricted only to those with a positive smear for parasitaemia) (B) at baseline, 14 days, and 6 months by treatment arm. Black lines indicate azithromycin and gray lines indicate placebo

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