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Author Notes:

E-mail Address : rschina@emory.edu

We thank all of the subjects who participated in this study for their time and dedication and SGS North America (contract research organization) for assistance with conducting the study.

Schinazi is also the founder and a major shareholder of RFS Pharma LLC. Emory University received no funding from ActivBiotics Pharma LLC or RFS Pharma LLC to perform this work, and vice versa.

Subject:

Research Funding:

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.

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.).

Keywords:

  • Science & Technology
  • Life Sciences & Biomedicine
  • Microbiology
  • Pharmacology & Pharmacy
  • MICROBIOLOGY
  • PHARMACOLOGY & PHARMACY
  • NONGONOCOCCAL URETHRITIS
  • ANTIBACTERIAL
  • GONORRHEA

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

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Journal Title:

Antimicrobial Agents and Chemotherapy

Volume:

Volume 58, Number 7

Publisher:

, Pages 4014-4019

Type of Work:

Article | Final Publisher PDF

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.

Copyright information:

© 2014, American Society for Microbiology.

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