A randomized, double-blind study comparing single-dose rifalazil with single-dose azithromycin for the empirical treatment of nongonococcal urethritis in men

Walter E. Stamm, Byron Batteiger, William M. McCormack, Patricia A. Totten, Andrew Sternlicht, Nancy M. Kivel

Research output: Contribution to journalArticle

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Abstract

OBJECTIVES: To determine the safety and effectiveness of single-dose rifalazil, a new rifamycin, for the treatment of nongonococcal urethritis (NGU). STUDY DESIGN: Randomized, double-blind trial comparing rifalazil, 2.5, 12.5 or 25 mg, with 1.0 g azithromycin for the treatment of NGU. One hundred and seventy men were evaluated for Chlamydia trachomatis, Ureaplasma urealyticum, and Mycoplasma genitalium infection before therapy and 2- and 5-weeks posttreatment. RESULTS: C. trachomatis, M. genitalium, and U. urealyticum were present in 42%, 24%, and 28% of subjects, respectively. Microbiologic eradication of C. trachomatis with rifalazil 25 mg at 2- and 5- weeks was 85% and 83%, respectively. Rifalazil was ineffective in eradicating M. genitalium and U. urealyticum. Overall clinical cure rates at 2- and 5-weeks were 86% (95% CI 67-96) and 59% (39-78) in the rifalazil-treated 25 mg group, and 77% (56-91) and 63% (41-81) in the azithromycin-treated group. CONCLUSIONS: Rifalazil was well tolerated and eradicates C. trachomatis but not M. genitalium and U. ureaplasma in men with NGU.

Original languageEnglish
Pages (from-to)545-552
Number of pages8
JournalSexually Transmitted Diseases
Volume34
Issue number8
DOIs
StatePublished - Aug 2007

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KRM 1648
Urethritis
Azithromycin
Mycoplasma genitalium
Double-Blind Method
Chlamydia trachomatis
Ureaplasma urealyticum
Therapeutics
Ureaplasma
Mycoplasma Infections

ASJC Scopus subject areas

  • Dermatology
  • Public Health, Environmental and Occupational Health
  • Microbiology (medical)

Cite this

A randomized, double-blind study comparing single-dose rifalazil with single-dose azithromycin for the empirical treatment of nongonococcal urethritis in men. / Stamm, Walter E.; Batteiger, Byron; McCormack, William M.; Totten, Patricia A.; Sternlicht, Andrew; Kivel, Nancy M.

In: Sexually Transmitted Diseases, Vol. 34, No. 8, 08.2007, p. 545-552.

Research output: Contribution to journalArticle

Stamm, Walter E. ; Batteiger, Byron ; McCormack, William M. ; Totten, Patricia A. ; Sternlicht, Andrew ; Kivel, Nancy M. / A randomized, double-blind study comparing single-dose rifalazil with single-dose azithromycin for the empirical treatment of nongonococcal urethritis in men. In: Sexually Transmitted Diseases. 2007 ; Vol. 34, No. 8. pp. 545-552.
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abstract = "OBJECTIVES: To determine the safety and effectiveness of single-dose rifalazil, a new rifamycin, for the treatment of nongonococcal urethritis (NGU). STUDY DESIGN: Randomized, double-blind trial comparing rifalazil, 2.5, 12.5 or 25 mg, with 1.0 g azithromycin for the treatment of NGU. One hundred and seventy men were evaluated for Chlamydia trachomatis, Ureaplasma urealyticum, and Mycoplasma genitalium infection before therapy and 2- and 5-weeks posttreatment. RESULTS: C. trachomatis, M. genitalium, and U. urealyticum were present in 42{\%}, 24{\%}, and 28{\%} of subjects, respectively. Microbiologic eradication of C. trachomatis with rifalazil 25 mg at 2- and 5- weeks was 85{\%} and 83{\%}, respectively. Rifalazil was ineffective in eradicating M. genitalium and U. urealyticum. Overall clinical cure rates at 2- and 5-weeks were 86{\%} (95{\%} CI 67-96) and 59{\%} (39-78) in the rifalazil-treated 25 mg group, and 77{\%} (56-91) and 63{\%} (41-81) in the azithromycin-treated group. CONCLUSIONS: Rifalazil was well tolerated and eradicates C. trachomatis but not M. genitalium and U. ureaplasma in men with NGU.",
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