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

被引:3
|
作者
Yang, Henglin [1 ]
Wang, Jingyan [2 ]
Liu, Hui [1 ]
Zhao, Yan [3 ]
Lakshmi, Seetha [4 ]
Li, Xingliang [1 ]
Nie, Renhua [1 ]
Li, Chunfu [1 ]
Wang, Hengye [1 ]
Cao, Yaming [3 ]
Menezes, Lynette [4 ]
Cui, Liwang [4 ]
机构
[1] Yunnan Prov Ctr Malaria Res, Yunnan Inst Parasit Dis, Puer, Yunnan, Peoples R China
[2] Acad Mil Med Sci, Inst Microbiol & Epidemiol, Beijing, Peoples R China
[3] China Med Univ, Coll Basic Med Sci, Dept Immunol, Shenyang, Liaoning, Peoples R China
[4] Univ S Florida, Morsani Coll Med, Dept Internal Med, 12901 Bruce B Downs Blvd, Tampa, FL 33620 USA
基金
美国国家卫生研究院;
关键词
naphthoquine-azithromycin; malaria; prophylaxis; protective efficacy; safety; PLASMODIUM-VIVAX MALARIA; ARTEMISININ RESISTANCE; DRUG-RESISTANCE; CHLOROQUINE; COMBINATION; PHOSPHATE;
D O I
10.1093/cid/ciaa1018
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
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.
引用
收藏
页码:E2470 / E2476
页数:7
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