{"doi":"10.1093/cid/ciaa1018","title":"Efficacy and Safety of a Naphthoquine-Azithromycin Coformulation for Malaria Prophylaxis in Southeast Asia: A Phase 3, Double-blind, Randomized, Placebo-controlled Trial","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.","journal":"Clinical Infectious Diseases","year":2020,"id":111841,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":4,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9544,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2020-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":530296,"name":"Jingyan Wang","orcid":"0000-0001-5838-8691","position":1,"is_corresponding":false},{"id":530297,"name":"Hui Liu","orcid":"0009-0003-3273-6979","position":2,"is_corresponding":false},{"id":308906,"name":"Yan Zhao","orcid":"0000-0002-7760-916X","position":3,"is_corresponding":false},{"id":531080,"name":"Seetha Lakshmi","orcid":null,"position":4,"is_corresponding":false},{"id":530298,"name":"Xingliang Li","orcid":"0000-0002-4182-1572","position":5,"is_corresponding":false},{"id":531081,"name":"Ren-hua Nie","orcid":null,"position":6,"is_corresponding":false},{"id":530299,"name":"Chunfu Li","orcid":"0000-0003-1858-2320","position":7,"is_corresponding":false},{"id":531082,"name":"Hengye Wang","orcid":null,"position":8,"is_corresponding":false},{"id":334156,"name":"Yaming Cao","orcid":"0000-0001-5315-1636","position":9,"is_corresponding":false},{"id":308911,"name":"Lynette Menezes","orcid":"0000-0002-0698-5061","position":10,"is_corresponding":false},{"id":308914,"name":"Liwang Cui","orcid":"0000-0002-8338-1974","position":11,"is_corresponding":false},{"id":531079,"name":"Henglin Yang","orcid":null,"position":0,"is_corresponding":true}],"reference_count":40,"raw_metadata":null,"created_at":"2026-07-18T23:13:09.353152Z","pmid":"32687174","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}