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Macrolide Resistance in MORDOR I — A Cluster-Randomized Trial in Niger

2019; Massachusetts Medical Society; Volume: 380; Issue: 23 Linguagem: Inglês

10.1056/nejmc1901535

1533-4406

Thuy Doan, Ahmed M. Arzika, Armin Hinterwirth, Ramatou Maliki, Lina Zhong, Susie Cummings, Samarpita Sarkar, Cindi Chen, Travis C. Porco, Jeremy D. Keenan, Thomas M. Lietman,

Tuberculosis Research and Epidemiology

Trial in NigerTo the Editor: Mass administration of azithromycin reduced childhood mortality in the trials MORDOR (Macrolides Oraux pour Réduire les Décès avec un Oeil sur la Résistance) I 1,2 and MORDOR II (conducted by Keenan et al., published in this issue of the Journal 3 ).However, antibiotic resistance remains a major concern, and MORDOR I did not include assessments of morbidity.We randomly selected 3371 children aged 1 to 59 months from the same pool of 30 Nigerien communities involved in MORDOR I (Fig. S1 in the Supplementary Appendix, available with the full text of this letter at NEJM.org).The children were randomly assigned to receive either azithromycin or placebo, which were distributed twice a year over 2 years, as in MORDOR I (for details, see the protocol, available at NEJM.org).The mean (±SD) coverage with azithromycin and placebo was 79±8% and 82±6%, respectively.Ethical approval was obtained from the University of California, San Francisco, Committee for Human Research and the Ethics Committee of the Niger Ministry of Health.We obtained oral consent from guardians before treatment and before collection of nasopharyngeal and rectal swabs.No incentives were offered.All analyses were conducted at the community level.We compared the proportions of macrolideresistant pneumococcus in the children in the azithromycin group and those in the placebo group with the use of broth dilution assays of pneumococcus isolated from nasopharyngeal swabs collected at 24 months (6 months after the fourth twice-yearly treatment).Pneumococcus isolation and resistance testing were performed according to standard protocols at ARUP (a ref-