Treatment of genitourinary tract infections with fluoroquinolones: activity in vitro, pharmacokinetics, and clinical efficacy in urinary tract infections and prostatitis

We compared the safety and efficacy of a single 400-mg dose of ofloxacin, ofloxacin (200 mg) once daily for 3 days, and trimethoprim-sulfamethoxazole (160:800 mg) twice daily for 7 days for the treatment of acute uncomplicated cystitis (urinary tract infection [UTI]) in women. At 5 weeks posttreatment, 35 (81%) of 43 patients treated with single-dose ofloxacin, 40 (89%) of 45 treated with 3 days of ofloxacin, and 41 (98%) of 42 treated with trimethoprim-sulfamethoxazole were cured (P = 0.03, single-dose ofloxacin group versus trimethoprim-sulfamethoxazole group). Retreatment for symptomatic recurrent UTI was given to 7 (16%) of 43 patients initially treated with single-dose ofloxacin, 3 (7%) of 45 patients treated with 3 days of ofloxacin, and 0 of 42 patients treated with trimethoprim-sulfamethoxazole (P = 0.01, single-dose ofloxacin group versus trimethoprim-sulfamethoxazole group). There was a trend in each of the three treatment groups toward an association between persistent or recurrent episodes of significant bacteriuria and a history of UTI in the past year and with diaphragm use. Ofloxacin was more effective than trimethoprim-sulfamethoxazole in eradicating Escherichia coli from rectal cultures during or soon after therapy, but there were no differences at later follow-up visits. Adverse effects were equally common among the three treatment groups. We conclude that single-dose ofloxacin was less effective than 7 days of trimethoprim-sulfamethoxazole for treatment of uncomplicated cystitis in women, while the 3-day ofloxacin regimen and the trimethoprim-sulfamethoxazole regimen were not significantly different in efficacy.The majority of cases of acute cystitis in young healthy women are effectively treated with conventional oral antimicrobial agents such as trimethoprim-sulfamethoxazole or nitrofurantoin. Ampicillin and sulfonamides have become less reliable in such cases because of the high prevalence of resistance to these agents among common uropathogens (10). The new fluoroquinolone antimicrobial agents, of which ofloxacin is one, have also been demonstrated to be effective for treatment of cystitis (24). While these agents are not considered the treatment of choice for uncomplicated cystitis, they are often used in patients who are intolerant of conventional agents, who have resistant pathogens, or in whom the presence of a complicating factor is more likely.Single-dose or 3-day regimens of antimicrobial agents are becoming increasingly popular for the treatment of uncomplicated cystitis because, compared with conventional regimens, they tend to be as effective and are associated with fewer adverse effects, better compliance, and lower cost (10). However, there are no published data on the use of the new fluoroquinolones in single-dose regimens for the treatment of uncomplicated cystitis in the United States. We therefore compared the safety and efficacy of ofloxacin in a single-dose regimen with a regimen of once-daily doses of ofloxacin for 3 days and with a conventional 7-day regimen of trimet...

Section: Resultsmentioning

confidence: 99%

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confidence: 99%

Single-dose and three-day regimens of ofloxacin versus trimethoprim-sulfamethoxazole for acute cystitis in women

Hooton

Johnson

Winter

et al. 1991

“…However, of the few published studies of ofloxacin for the treatment of chlamydial cervical infection, all of which are small, some of the others have also shown a similar trend (Table 1). Ciprofloxacin, which has a somewhat higher MIC against 90% of the C. trachomatis strains tested than ofloxacin (1.6 versus 0.8 ,ug/ml, respectively [12]) and is less well absorbed, proved ineffective in the treatment of chlamydial urethritis in men because of relapses occurring 2 to 4 weeks posttreatment (7). Thus, although it appears that ofloxacin is more effective than ciprofloxacin in eradicating chlamydia, larger treatment studies with ofloxacin and a 4-to 6-week follow-up are indicated to better evaluate the possibility of late chlamydial relapses.…”

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confidence: 99%

Ofloxacin versus doxycycline for treatment of cervical infection with Chlamydia trachomatis

Hooton

Batteiger

Judson

et al. 1992

Women with culture-proven Chlamydia trachomatis cervical infection were randomized to receive either ofloxacin (300 mg) or doxycycline (100 mg), orally twice daily for 7 days. All 56 had negative cultures 5 to 9 days after treatment. Four weeks after treatment, 26 (93%) of 28 ofloxacin-treated patients and all 22 doxycycline-treated patients were cured. We conclude that 300 mg of ofloxacin given twice daily for 7 days provides effective therapy for chlamydial infection of the cervix.Mucopurulent cervicitis is among the most common sexually transmitted disease syndromes in women and can eventually lead to pelvic inflammatory disease, infertility, and obstetrical complications. It has not been as well studied as urethritis in men, but it is thought to have both similar prevalence and causes (3). As in male nongonococcal urethritis, Chlamydia trachomatis is the most common etiologic pathogen, causing as many as 50% of cases, whereas Neisseria gonorrhoeae is less common (3). Although tetracycline congeners and erythromycin are effective in eradicating C. trachomatis, they cause frequent side effects, must be taken two to four times daily, and are not reliably effective against N. gonorrhoeae. A single agent effective against both of these pathogens in women with mucopurulent cervicitis would be desirable for reasons of patient convenience and cost. The new fluoroquinolone antibiotics have excellent in vitro activity against both N. gonorrhoeae and C. trachomatis, and some have the potential for once-daily therapy (6). In particular, ofloxacin has been very effective in eradicating gonococcal infections and has been demonstrated in studies of men with urethritis and in small numbers of women with cervicitis to be as active against chlamydia as doxycycline (6). However, only small numbers of women were studied and posttreatment follow-up was no longer than 2 weeks in these studies. We report findings from a multicenter study comparing ofloxacin and doxycycline for treatment of chlamydial infection of the cervix with a follow-up visit 4 weeks after treatment.Data from four centers which took part in a multicenter study by using identical protocols were combined for this report Women were eligible for enrollment if they were between 18 and 65 years old, were not pregnant and using contraception, had received no systemic antimicrobial therapy within 30 days and no intravaginal antibacterial agent within 14 days prior to enrollment, had no allergy to carboxyquinolones or doxycycline, had no other significant medical illnesses, and had one or more of the following: 10 or more polymorphonuclear cells per high-power field (1,000 x) on a cervical gram stain, mucopurulent endocervical discharge, or a positive cervical culture for C. trachomatis. At enrollment, subjects underwent a medical history, physical examination, cervical gram stain, and culture for N. gonorrhoeae and C. trachomatis. Patients were then randomized to receive either ofloxacin (300 mg) or doxycycline hyclate (100 mg), orally twice daily for 7 days. Medicati...

“…These include ease of administration, patient acceptance, decreased cost, and fewer side effects compared with injections. Newer oral quinolones differ in pharmacokinetics and in vitro activity (6,18,21,28). However, in view of the proven efficacy of single-dose therapy with newer quinolones for urethral gonorrhea (9,22) and lack of single-dose efficacy against chlamydiae without significant adverse effects (13,25), the main factors in choosing which quinolone to use are cost and adverse effects (13 …”

Section: Resultsmentioning

confidence: 99%

“…Ciprofloxacin, a new fluorinated carboxyquinolone, achieves high concentrations in urethral and prostatic secretions and is very active in vitro against N. gonorrhoeae (23,28). It is effective as single-dose oral therapy for gonococcal urethritis (1,2,23), but only limited experience has been acquired with penicillinase-producing strains (PPNG) intramuscularly plus a placebo capsule by mouth, identical in appearance to ciprofloxacin capsules.…”

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confidence: 99%

Oral ciprofloxacin versus ceftriaxone for the treatment of urethritis from resistant Neisseria gonorrhoeae in Zambia

Bryan

Hira

Brady

et al. 1990

Neisseria gonorrhoeae strains resistant to treatment with penicillin, tetracycline, and/or spectinomycin are increasing in prevalence in many parts of the world. In Zambia, 52% of N. gonorrhoeae isolates produced ,-lactamase in 1986. Few oral regimens have proven effective for treatment of resistant N. gonorrhoeae. We conducted a prospective, double-blind, randomized clinical trial of 250 mg of ciprofloxacin given orally versus 250 mg of ceftriaxone given intramuscularly for treatment of uncomplicated gonococcal urethritis in adult males. Two hundred men were enrolled and treated. The two groups were comparable in age (27.5 years), prevalence of latent syphilis (14 and 10%), and human immunodeficiency virus infection (32 and 38%). Of 165 patients with cultures positive for N. gonorrhoeae who returned for follow-up, ciprofloxacin cured 83 of 83 (100%), including 26 with penicillinase-producing N. gonorrhoeae (PPNG) and 21 with N. gonorrhoeae with chromosomally mediated resistance to multiple antibiotics (CMRNG), and ceftriaxone cured 81 of 82 (98.7%), including 30 with PPNG and 19 with CMRNG. Both treatment regimens were well tolerated. Chiamydia trachomatis in urethral exudate was found by direct fluorescent-antibody microscopic examination or by culture in 10 (5%) participants. All N. gonorrhoeae isolates were inhibited by ceftriaxone at 0.06 ,ug/ml, except one which was inhibited at 0.125 ,ug/ml, while ciprofloxacin inhibited all isolates at 0.03 ,ug/ml. Ciprofloxacin is a safe and effective therapy for uncomplicated gonococcal urethritis, including that caused by PPNG and CMRNG in human immunodeficiency virus-infected men.