Daily Oral Grepafloxacin vs. Twice Daily OralDoxycycline in the Treatment ofChlamydia trachomatisEndocervical Infection

摘要

Objective:To compare the efficacy and safety of a 7-day course of treatment with oral grepafloxacin,400 mg once daily, and oral doxycycline, 100 mg twice daily, in patients with chlamydial cervicitis.Methods:Women aged 18 years or older attending 17 sexually transmitted disease clinics in theUnited States who had clinical signs of mucopurulent cervicitis or who had a recent positive cultureor nonculture test forChlamydia trachomatisor who had contact with a male partner with a positiveculture forC. trachomatiswere enrolled into this randomized, double-blind, active-controlled clinicalstudy. The diagnosis of chlamydial cervicitis was based on culture forC. trachomatis. Patients wererandomized to receive a 7-day course of treatment with either oral grepafloxacin, 400 mg once daily,or oral doxycycline, 100 mg twice daily. Response to therapy was assessed 3–8 days and 21–28 daysafter completion of treatment. The primary measure of efficacy was eradication ofC. trachomatisatthe 21–28 day follow-up visit. Clinical success, defined as improvement or complete resolution of thesigns and symptoms of cervicitis, was a secondary measure of efficacy.Results:Of the 451 female patients enrolled, 228 received grepafloxacin and 223 received doxycycline.In all, 154/451 (35%) patients were evaluable at the 21–28 day follow-up (81 who receivedgrepafloxacin and 73 who received doxycycline). Microbiologic and clinical success rates demonstratedthe equivalence of the two treatments. TheC. trachomatiseradication rates were 96.3%(78/81) and 98.6% (72/73) for patients receiving grepafloxacin or doxycycline, respectively. The twostudy drugs were also equivalent in resolving clinical signs and symptoms, with clinical successrates of 88.9% (64/72) and 89.5% (51/57) for patients treated with grepafloxacin and doxycycline,respectively. Both drugs were well tolerated, with 47% of patients receiving grepafloxacin and 46%of patients receiving doxycycline experiencing drug-related adverse events, none of which wasserious.Conclusions:Seven days of treatment with oral grepafloxacin, 400 mg once daily, was as effectiveas 7 days of treatment with oral doxycycline, 100 mg twice daily, in patients with cervicitis causedbyC. trachomatis. Both agents were well tolerated and had comparable safety profiles. Grepafloxacin’sonce-daily dosing regimen may offer advantages in terms of patient compliance.