An open label study of the safety and efficacy of a single dose of weekly chloroquine and azithromycin administered for
- PDF / 1,640,146 Bytes
- 14 Pages / 595.276 x 790.866 pts Page_size
- 23 Downloads / 156 Views
Malaria Journal Open Access
RESEARCH
An open label study of the safety and efficacy of a single dose of weekly chloroquine and azithromycin administered for malaria prophylaxis in healthy adults challenged with 7G8 chloroquine‑resistant Plasmodium falciparum in a controlled human malaria infection model Jeffrey Livezey1* , Patrick Twomey2, Meshell Morrison2, Susan Cicatelli2, Elizabeth H. Duncan2, Melinda Hamer2, Christine Lee2, Jack Hutter2, Kristin Mills2, Jesse DeLuca2, Lucas Poon2, Daniel Selig2, Chau Vuong2, Jason Sousa2, Thomas Oliver1, Jason Bennett2, James E. Moon2, April Sikaffy2, Martha Sedegah3, Donna Tosh2, Mara Kreishman‑Deitrick2 and Paige Waterman2
Abstract Background: Malaria remains the top infectious disease threat facing the U.S. military in many forward operating environments. Compliance with malaria chemoprophylaxis remains a critical component in preventing malaria in the deployed Service Member. Studies of previous military operations show that compliance is consistently higher with weekly versus daily dosing regimens. Current FDA approved weekly chemoprophylaxis options have contraindications that can limit prescribing. The combination of chloroquine (CQ) with azithromycin (AZ) has previously been shown to be an efficacious treatment option for malaria, has pharmacokinetics compatible with weekly dosing, and has shown synergy when combined in vitro. Methods: In this open label study, 18 healthy volunteers, aged 18–50 years (inclusive), were randomly assigned to receive either 300 mg CQ or 300 mg CQ and 2 gm azithromycin (CQAZ) of directly observed therapy, weekly for 3 weeks prior to undergoing mosquito bite challenge with chloroquine-resistant Plasmodium falciparum. Volunteers that remained asymptomatic and had no evidence of parasitaemia continued to receive weekly post-exposure chemoprophylaxis for 3 weeks following malaria challenge. The primary endpoint was the number of volunteers that remained asymptomatic and had no evidence of parasitaemia 28 days after the malaria challenge. Results: All 6 (100%) volunteers randomized to the CQ control group became symptomatic with parasitaemia dur‑ ing the 28-day post-challenge period. Only 1/12 (8.3%) of volunteers in the CQAZ group developed symptoms and
*Correspondence: [email protected] 1 Uniformed Services University of the Health Sciences, 4301 Jones Bridge Rd, Bethesda, MD 20814, USA Full list of author information is available at the end of the article © The Author(s) 2020. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the arti
Data Loading...
