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Efficacy and Safety of a Naphthoquine-Azithromycin Coformulation for Malaria Prophylaxis in Southeast Asia: A Phase 3, Double-blind, Randomized, Placebo-controlled Trial.

Authors :
Yang, Henglin
Wang, Jingyan
Liu, Hui
Zhao, Yan
Lakshmi, Seetha
Li, Xingliang
Nie, Renhua
Li, Chunfu
Wang, Hengye
Cao, Yaming
Menezes, Lynette
Cui, Liwang
Source :
Clinical Infectious Diseases. 10/1/2021, Vol. 73 Issue 7, pe2470-e2476. 7p.
Publication Year :
2021

Abstract

Background A prophylactic antimalarial drug that is both effective for protection and improves compliance is in high demand. Methods We conducted a randomized, placebo-controlled, double-blinded phase 3 trial to evaluate the 1:1 fixed-dose combination of naphthoquine-azithromycin (NQAZ) for safety and protection against Plasmodium infections in villages along the China-Myanmar border. A total of 631 residents, 5–65 years of age, were randomized into the drug group (n = 319) and the placebo group (n = 312) to receive NZAQ and placebo, respectively, as a single-dose monthly treatment. Follow-ups were conducted weekly to monitor for adverse events and malaria infections. Results Of the 531 subjects completing the trial, there were 46 and 3 blood smear–positive Plasmodium infections in the placebo and treatment groups, respectively. For the intent-to-treat analysis, the single-dose monthly NQAZ treatment had 93.62% protective efficacy (95% confidence interval [CI]: 91.72%–95.52%). For the per-protocol analysis, NQAZ treatment provided a 93.04% protective efficacy (95% CI: 90.98%–95.1%). Three smear-positive cases in the NQAZ group were all due to acute falciparum malaria. In comparison, NQAZ treatment provided 100% protection against the relapsing malaria Plasmodium vivax and Plasmodium ovale. The treatment group had 5.6% of participants experiencing transient elevation of liver aminotransferases compared with 2.2% in the placebo group (P >.05). Conclusions Monthly prophylaxis with NQAZ tablets was well tolerated and highly effective for preventing Plasmodium infections. It may prove useful for eliminating P. vivax in areas with a high prevalence of glucose-6-phosphate dehydrogenase deficiency in the population. Clinical Trials Registration ChiCTR1800020140. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
10584838
Volume :
73
Issue :
7
Database :
Academic Search Index
Journal :
Clinical Infectious Diseases
Publication Type :
Academic Journal
Accession number :
152854309
Full Text :
https://doi.org/10.1093/cid/ciaa1018