title: Randomized, double-blind, multicenter safety and efficacy study of rifalazil compared with azithromycin for treatment of uncomplicated genital Chlamydia trachomatis infection in women.
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).
authors.affiliation: University of Alabama at Birmingham, Birmingham, Alabama, USA.
authors.forename: William M
authors.initials: WM
authors.lastname: Geisler
authors.affiliation: RFS Pharma, Tucker, Georgia, USA.
authors.forename: Maria Luz G
authors.initials: ML
authors.lastname: Pascual
authors.affiliation: RFS Pharma, Tucker, Georgia, USA.
authors.forename: Judy
authors.initials: J
authors.lastname: Mathew
authors.affiliation: Medical Center for Clinical Research, San Diego, California, USA.
authors.forename: William D
authors.initials: WD
authors.lastname: Koltun
authors.affiliation: Tidewater Physicians for Women, Norfolk, Virginia, USA.
authors.forename: Franklin
authors.initials: F
authors.lastname: Morgan
authors.affiliation: Indiana University School of Medicine, Indianapolis, Indiana, USA.
authors.forename: Byron E
authors.initials: BE
authors.lastname: Batteiger
authors.affiliation: Office of Annette Mayes, M.D., Las Vegas, Nevada, USA.
authors.forename: Annette
authors.initials: A
authors.lastname: Mayes
authors.affiliation: Center for AIDS Research, Emory University School of Medicine and Veterans Affairs Medical Center, Atlanta, Georgia, USA.
authors.forename: Sijia
authors.initials: S
authors.lastname: Tao
authors.affiliation: Center for AIDS Research, Emory University School of Medicine and Veterans Affairs Medical Center, Atlanta, Georgia, USA.
authors.forename: Selwyn J
authors.initials: SJ
authors.lastname: Hurwitz
authors.affiliation: ActivBiotics Pharma, Tucker, Georgia, USA.
authors.forename: Chalom
authors.initials: C
authors.lastname: Sayada
authors.affiliation: Center for AIDS Research, Emory University School of Medicine and Veterans Affairs Medical Center, Atlanta, Georgia, USA rschina@emory.edu.
authors.forename: Raymond F
authors.initials: RF
authors.lastname: Schinazi
mesh_terms: D000328:Adult; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D017963:Azithromycin / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D002690:Chlamydia Infections / Q000188:drug therapy* / Q000382:microbiology; D002692:Chlamydia trachomatis; D004311:Double-Blind Method; D023381:Endpoint Determination; D005260:Female; D005831:Genital Diseases, Female / Q000188:drug therapy* / Q000382:microbiology; D006801:Humans; D012294:Rifamycins / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D012294:Rifamycins; C068980:KRM 1648; D017963:Azithromycin