Journal
CLINICAL INFECTIOUS DISEASES
Volume 73, Issue 7, Pages E2470-E2476Publisher
OXFORD UNIV PRESS INC
DOI: 10.1093/cid/ciaa1018
Keywords
naphthoquine-azithromycin; malaria; prophylaxis; protective efficacy; safety
Categories
Funding
- National Scientific and Technological Program, China [2008ZXJ09004-016]
- National Institute of Allergy and Infectious Diseases, US National Institutes of Health [U19 AI089672]
Ask authors/readers for more resources
The study showed that monthly prophylaxis with NQAZ tablets was well tolerated and highly effective in preventing Plasmodium infections, particularly in protecting against P. vivax.
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.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available