A phase-II study of trovafloxacin for the treatment of Chlamydia trachomatis infections.

BACKGROUND

Chlamydia trachomatis can cause an insidious, asymptomatic infection in both men and women. Trovafloxacin, a fluoronaphthyridone antibiotic related to the fluoroquinolones, has broad antibacterial activity that encompasses C. trachomatis.

GOAL OF STUDY: We designed a phase-II study to determine the efficacy and safety of trovafloxacin for chlamydial infections.

STUDY

DESIGN

Four once-daily dosing regimens were used: 200 mg for 7 days, 200 mg for 5 days, 100 mg for 7 days, and 50 mg for 7 days.

RESULTS

Sixty-four men and 66 women were enrolled. Of the 73 bacteriologically evaluable patients, 20 received 200 mg for 7 days, 18 received 200 mg for 5 days, 14 received 100 mg for 7 days, and 21 received 50 mg for 7 days. Bacteriologic failure occurred in 1 patient (5%) in the 200-mg 7-day group, 2 patients (14%) in the 100-mg group, and 1 patient (5%) in the 50-mg group. No clinical failures were noted among the 30 C. trachomatis infected men with nongonococcal urethritis, although 1 patient had only improved at the final visit. Safety data were available from 119 patients. Of 86 patients receiving the three highest dosing regimens, 17 (20%) had at least one adverse event, judged treatment-related in only 9 (10 %). Of 33 patients receiving the lowest dose, 5 (15%) had an adverse event, three (9%) of which were considered treatment related. No adverse event was severe.

CONCLUSION

In doses ranging from 200 mg to 50 mg daily for a week and 200 mg daily for 5 days, trovafloxacin appears to be effective for chlamydial infections and is well tolerated.