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

Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America
Henglin YangLiwang Cui

Abstract

A prophylactic antimalarial drug that is both effective for protection and improves compliance is in high demand. 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. 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 Pl...Continue Reading

References

Feb 24, 1999·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·W R TaylorJ Berman
Jan 28, 2004·Acta Tropica·Jing-yan WangBo-an Wu
Dec 10, 2008·The New England Journal of Medicine·Harald NoedlUNKNOWN Artemisinin Resistance in Cambodia 1 (ARC1) Study Consortium
Jul 15, 2009·Clinical Microbiology Reviews·J Kevin Baird
Jul 31, 2009·The New England Journal of Medicine·Arjen M DondorpNicholas J White
Feb 15, 2012·Antimicrobial Agents and Chemotherapy·Kevin T BattyTimothy M E Davis
Sep 12, 2012·Infectious Disease Clinics of North America·Blaise Genton, Valérie D'Acremont
Jul 31, 2014·The New England Journal of Medicine·Elizabeth A AshleyUNKNOWN Tracking Resistance to Artemisinin Collaboration (TRAC)
Sep 13, 2014·The Lancet Infectious Diseases·Ric N PriceNicholas J White
Aug 12, 2015·The American Journal of Tropical Medicine and Hygiene·Liwang CuiPhilip J Rosenthal
Nov 12, 2016·International Journal for Parasitology·J Kevin Baird
Apr 30, 2017·Travel Medicine and Infectious Disease·J Kevin Baird
Sep 9, 2017·Tropical Diseases, Travel Medicine and Vaccines·J Kevin Baird
Nov 1, 2018·Journal of Travel Medicine·J Kevin Baird
Feb 1, 2019·PLoS Neglected Tropical Diseases·Katherine A TwohigRosalind E Howes
Aug 2, 2019·Clinical Microbiology Reviews·J Kevin Baird
Sep 14, 2019·Malaria Journal·Jinting GengLiwang Cui

❮ Previous
Next ❯

Related Concepts

Related Feeds

Antimalarial Agents (ASM)

Antimalarial agents, also known as antimalarials, are designed to prevent or cure malaria. Discover the latest research on antimalarial agents here.

Antimalarial Agents

Antimalarial agents, also known as antimalarials, are designed to prevent or cure malaria. Discover the latest research on antimalarial agents here.

Related Papers

The Medical Journal of Australia
I F Cooke
Zhongguo ji sheng chong xue yu ji sheng chong bing za zhi = Chinese journal of parasitology & parasitic diseases
Kai WuYan Yang
The American Journal of Tropical Medicine and Hygiene
J Kevin BairdRic N Price
The Journal of Antimicrobial Chemotherapy
M Whitby
© 2021 Meta ULC. All rights reserved