Randomized, Double-Blind, Multicenter Safety and Efficacy Study of Rifalazil Compared with Azithromycin for Treatment of Uncomplicated Genital Chlamydia trachomatis Infection in Women

• Type of Material: Article
• Authors: William M. Geisler, University of Alabama; Maria Luz G. Pascual, RFS Pharma; Judy Mathew, RFS Pharma; William D. Koltun, Medical Center for Clinical Research; Franklin Morgan, Tidewater Physicians for Women; Byron E. Batteiger, Indiana University School of Medicine; Annette Mayes, Office of Annette Mayes; Sijia Tao, Emory University; Selwyn Hurwitz, Emory University; Chalom Sayada, ActivBiotics Pharma; Raymond F Schinazi, Emory University
• Language: English
• Date: 2014-07-01
• Publisher: American Society for Microbiology
• Publication Version: Final Published Version
• Copyright Statement: © 2014, American Society for Microbiology.
• Final Published Version (URL): http://dx.doi.org/10.1128/AAC.02521-14
• Title of Journal or Parent Work: Antimicrobial Agents and Chemotherapy
• ISSN: 0066-4804
• Volume: 58
• Issue: 7
• Start Page: 4014
• End Page: 4019
• Grant/Funding Information: This work was supported by Raymond F. Schinazi and in part by NIH grant 5P30-AI-50409 (to R.F.S.) (CFAR) and by the Department of Veterans Affairs (to R.F.S.).; The study was sponsored by ActivBiotics Pharma LLC. Raymond F. Schinazi (RFS) and Chalom Sayada are the founders and major shareholders of ActivBiotics Pharma LLC. R. F.
• Keywords: GONORRHEA; Science & Technology; ANTIBACTERIAL; PHARMACOLOGY & PHARMACY; MICROBIOLOGY; Microbiology; NONGONOCOCCAL URETHRITIS; Pharmacology & Pharmacy; Life Sciences & Biomedicine
• Research Categories: Health Sciences, General

Abstract

A randomized, double-blind study comparing single-dose chlamydia therapies of oral rifalazil (25 mg) and azithromycin (1 g) was conducted in 82 women with uncomplicated genital Chlamydia trachomatis infection. The microbiologic cure rate of C. trachomatis with rifalazil (n = 33) was 84.8% at the visit on day 22 to 26 (test-of-cure visit), versus 92.1% with azithromycin (n = 38), and the number of treatment failures in each group was 5 and 3, respectively. The difference in cure rate was -7.3%, with a lower limit of the 95% confidence interval (95% CI) of -22.5, and thus, noninferiority was not established at the prespecified margin (lower limit of CI of -15%). The overall treatment-emergent adverse event (TEAE) and treatment-related TEAE rates were lower in the rifalazil group (68% and 55%) than in the azithromycin group (71% and 62%), respectively. Subjects classified as treatment failures at day 22 to 26 had a lower mean plasma concentration of rifalazil at the visit on day 8 to 12 than those classified as treatment cures, but this difference was not significant; however, the levels were similar for both groups at the visit on day 22 to 26. A single 25-mg dose of rifalazil was well tolerated and eradicated C. trachomatis in most of these women with uncomplicated genital C. trachomatis infection. (The study was registered at clinicaltrials.gov under registration no. NCT01631201). Copyright © 2014, American Society for Microbiology. All Rights Reserved.