BACKGROUND: This randomized open-label study assessed the penetration into gynecologic tissues of trovafloxacin, a new broad-spectrum, fourth-generation fluoroquinolone with in vitro activity against anaerobes, gram-positive, gram-negative, and atypical pathogens. METHODS:Women undergoinghysterectomy or hysterectomy and adnexectomy received 200 mg trovafloxacin orally before surgery as a single dose or as multiple doses. Samples of genital tract tissue and serum were obtained simultaneously during surgery. RESULTS: In the single-dose group, trovafloxacin concentrations in genital tract tissues were measurable for up to 30 hours. Tissue concentrations of trovafloxacin after multiple doses were comparable to those after single doses. Mean tissue: serum concentration ratios after a single dose were greatest in the ovary (1.6 microg/g) and comparable in uterus, myometrium, cervix, and fallopian tubes (0.5 to 0.7 microg/g). Adverse events after a single dose were minor. CONCLUSIONS: A daily dose of 200 mg trovafloxacin produces gynecologic tissue concentrations that persist for up to 30 hours at levels necessary to prevent or treat pelvic infections. This dosing regimen is well tolerated.
RCT Entities:
BACKGROUND: This randomized open-label study assessed the penetration into gynecologic tissues of trovafloxacin, a new broad-spectrum, fourth-generation fluoroquinolone with in vitro activity against anaerobes, gram-positive, gram-negative, and atypical pathogens. METHODS:Women undergoing hysterectomy or hysterectomy and adnexectomy received 200 mg trovafloxacin orally before surgery as a single dose or as multiple doses. Samples of genital tract tissue and serum were obtained simultaneously during surgery. RESULTS: In the single-dose group, trovafloxacin concentrations in genital tract tissues were measurable for up to 30 hours. Tissue concentrations of trovafloxacin after multiple doses were comparable to those after single doses. Mean tissue: serum concentration ratios after a single dose were greatest in the ovary (1.6 microg/g) and comparable in uterus, myometrium, cervix, and fallopian tubes (0.5 to 0.7 microg/g). Adverse events after a single dose were minor. CONCLUSIONS: A daily dose of 200 mg trovafloxacin produces gynecologic tissue concentrations that persist for up to 30 hours at levels necessary to prevent or treat pelvic infections. This dosing regimen is well tolerated.