Double-blind comparison of trovafloxacin and doxycycline in the treatment of uncomplicated Chlamydial urethritis and cervicitis. Trovafloxacin Chlamydial Urethritis/Cervicitis Study Group.
BACKGROUND
Chlamydia trachomatis is among the most common sexually transmitted bacteria worldwide. With excellent activity against C. trachomatis and Neisseria gonorrhoeae and prolonged elimination half-life allowing once-daily dosage, the fluoroquinolone trovafloxacin has potential advantages in the treatment of uncomplicated chlamydial infection.


OBJECTIVE
This study compared the efficacy of trovafloxacin with that of doxycycline for the treatment of uncomplicated chlamydial infection.


METHODS
In a double-blind, multicenter trial, trovafloxacin 200 mg was administered once daily for 5 days and doxycycline 100 mg was administered twice daily for 7 days to patients with uncomplicated chlamydial urethritis or cervicitis. Follow-up visits were conducted 10, 21, and 35 days after enrollment.


RESULTS
Of the 970 patients (403 men, 567 women) observed, 511 were microbiologically evaluable and 360 were clinically evaluable. C. trachomatis eradication rates in the trovafloxacin and doxycycline groups were equivalent in women (95% and 97%, respectively), but not in men (89% and 99%). Similarly, rates of clinical success (cure plus improvement) demonstrated equivalence of trovafloxacin and doxycycline in women (96% and 94%), but not in men (94% and 100%). The most frequent treatment-related adverse events were dizziness, nausea, and headache in patients given trovafloxacin, and nausea, vomiting, and headache in patients given doxycycline. Treatment-related discontinuations were comparable between the drug groups.


CONCLUSIONS
Trovafloxacin given once daily for 5 days was clinically and bacteriologically equivalent to doxycycline given twice daily for 7 days in women with uncomplicated chlamydial cervicitis. This equivalence was not demonstrated in men with uncomplicated chlamydial urethritis.
McCormack
W M
WM
State University of New York, Health Science Center, Brooklyn 11203, USA.
Dalu
Z A
ZA
Martin
D H
DH
Hook
E W
EW
Laisi
R
R
Kell
P
P
Pluck
N D
ND
Johnson
R B
RB
D000293:Adolescent; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000890:Anti-Infective Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002690:Chlamydia Infections / Q000188:drug therapy*; D002692:Chlamydia trachomatis; D004311:Double-Blind Method; D004318:Doxycycline / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D024841:Fluoroquinolones; D006801:Humans; D008297:Male; D008875:Middle Aged; D009287:Naphthyridines / Q000009:adverse effects / Q000627:therapeutic use*; D012737:Sex Factors; D014526:Urethritis / Q000188:drug therapy* / Q000382:microbiology; D002575:Uterine Cervicitis / Q000188:drug therapy* / Q000382:microbiology
D000900:Anti-Bacterial Agents; D000890:Anti-Infective Agents; D024841:Fluoroquinolones; D009287:Naphthyridines; C080163:trovafloxacin; D004318:Doxycycline