A randomized, double-blind study comparing single-dose rifalazil with single-dose azithromycin for the empirical treatment of nongonococcal urethritis in men.
OBJECTIVE
To determine the safety and effectiveness of single-dose rifalazil, a new rifamycin, for the treatment of nongonococcal urethritis (NGU).


METHODS
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.
Stamm
Walter E
WE
University of Washington, Department of Medicine, Seattle, Washington 98195, USA. wes@u.washington.edu
Batteiger
Byron E
BE
McCormack
William M
WM
Totten
Patricia A
PA
Sternlicht
Andrew
A
Kivel
Nancy M
NM
D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D017963:Azithromycin / Q000008:administration & dosage / Q000627:therapeutic use*; D002690:Chlamydia Infections / Q000188:drug therapy / Q000473:pathology; D002692:Chlamydia trachomatis; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D006801:Humans; D008297:Male; D009175:Mycoplasma Infections / Q000188:drug therapy / Q000473:pathology; D045704:Mycoplasma genitalium; D012294:Rifamycins / Q000008:administration & dosage / Q000627:therapeutic use*; D015231:Sexually Transmitted Diseases, Bacterial / Q000188:drug therapy* / Q000382:microbiology / Q000473:pathology; D016896:Treatment Outcome; D016869:Ureaplasma Infections / Q000188:drug therapy / Q000473:pathology; D016990:Ureaplasma urealyticum; D014526:Urethritis / Q000188:drug therapy* / Q000473:pathology
D000900:Anti-Bacterial Agents; D012294:Rifamycins; C068980:KRM 1648; D017963:Azithromycin