Randomized, double-blind, multicenter safety and efficacy study of rifalazil compared with azithromycin for treatment of uncomplicated genital Chlamydia trachomatis infection in women

William M. Geisler, Maria Luz G Pascual, Judy Mathew, William D. Koltun, Franklin Morgan, Byron Batteiger, Annette Mayes, Sijia Tao, Selwyn J. Hurwitz, Chalom Sayada, Raymond F. Schinazi

Research output: Contribution to journalArticle

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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).

Original languageEnglish
Pages (from-to)4014-4019
Number of pages6
JournalAntimicrobial Agents and Chemotherapy
Volume58
Issue number7
DOIs
StatePublished - 2014

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KRM 1648
Chlamydia Infections
Azithromycin
Chlamydia trachomatis
Safety
Treatment Failure
Therapeutics
Chlamydia
Double-Blind Method
Confidence Intervals

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Pharmacology
  • Infectious Diseases

Cite this

Randomized, double-blind, multicenter safety and efficacy study of rifalazil compared with azithromycin for treatment of uncomplicated genital Chlamydia trachomatis infection in women. / Geisler, William M.; Pascual, Maria Luz G; Mathew, Judy; Koltun, William D.; Morgan, Franklin; Batteiger, Byron; Mayes, Annette; Tao, Sijia; Hurwitz, Selwyn J.; Sayada, Chalom; Schinazi, Raymond F.

In: Antimicrobial Agents and Chemotherapy, Vol. 58, No. 7, 2014, p. 4014-4019.

Research output: Contribution to journalArticle

Geisler, William M. ; Pascual, Maria Luz G ; Mathew, Judy ; Koltun, William D. ; Morgan, Franklin ; Batteiger, Byron ; Mayes, Annette ; Tao, Sijia ; Hurwitz, Selwyn J. ; Sayada, Chalom ; Schinazi, Raymond F. / Randomized, double-blind, multicenter safety and efficacy study of rifalazil compared with azithromycin for treatment of uncomplicated genital Chlamydia trachomatis infection in women. In: Antimicrobial Agents and Chemotherapy. 2014 ; Vol. 58, No. 7. pp. 4014-4019.
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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).",
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AU - Mathew, Judy

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AU - Morgan, Franklin

AU - Batteiger, Byron

AU - Mayes, Annette

AU - Tao, Sijia

AU - Hurwitz, Selwyn J.

AU - Sayada, Chalom

AU - Schinazi, Raymond F.

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N2 - 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).

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