{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T09:08:08Z","timestamp":1740128888907,"version":"3.37.3"},"reference-count":40,"publisher":"Oxford University Press (OUP)","issue":"7","license":[{"start":{"date-parts":[[2020,7,20]],"date-time":"2020-07-20T00:00:00Z","timestamp":1595203200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"funder":[{"name":"National Scientific and Technological Program, China","award":["2008ZXJ09004-016"],"award-info":[{"award-number":["2008ZXJ09004-016"]}]},{"DOI":"10.13039\/100000060","name":"National Institute of Allergy and Infectious Diseases","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["U19 AI089672"],"award-info":[{"award-number":["U19 AI089672"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,10,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>A prophylactic antimalarial drug that is both effective for protection and improves compliance is in high demand.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>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\u201365 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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Of the 531 subjects completing the trial, there were 46 and 3 blood smear\u2013positive 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%\u201395.52%). For the per-protocol analysis, NQAZ treatment provided a 93.04% protective efficacy (95% CI: 90.98%\u201395.1%). 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 &amp;gt; .05).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Clinical Trials Registration<\/jats:title>\n                  <jats:p>ChiCTR1800020140.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/cid\/ciaa1018","type":"journal-article","created":{"date-parts":[[2020,7,14]],"date-time":"2020-07-14T19:08:57Z","timestamp":1594753737000},"page":"e2470-e2476","source":"Crossref","is-referenced-by-count":4,"title":["Efficacy and Safety of a Naphthoquine-Azithromycin Coformulation for Malaria Prophylaxis in Southeast Asia: A Phase 3, Double-blind, Randomized, Placebo-controlled Trial"],"prefix":"10.1093","volume":"73","author":[{"given":"Henglin","family":"Yang","sequence":"first","affiliation":[{"name":"Yunnan Institute of Parasitic Diseases, Yunnan Provincial Center of Malaria Research, Pu\u2019er, Yunnan, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jingyan","family":"Wang","sequence":"additional","affiliation":[{"name":"Institute of Microbiology and Epidemiology, Chinese Academy of Military Medical Sciences, Beijing, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hui","family":"Liu","sequence":"additional","affiliation":[{"name":"Yunnan Institute of Parasitic Diseases, Yunnan Provincial Center of Malaria Research, Pu\u2019er, Yunnan, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yan","family":"Zhao","sequence":"additional","affiliation":[{"name":"Department of Immunology, College of Basic Medical Sciences, China Medical University, Shenyang, Liaoning, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Seetha","family":"Lakshmi","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Morsani College of Medicine, University of South Florida, Tampa, Florida, 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