Single-dose ciprofloxacin at 100 versus 250 mg for treatment of uncomplicated urinary tract infections in women

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: Resultssupporting

confidence: 79%

“…We also studied the effects of these regimens on rectal and perineal colonization with coliforms. * 7 days. The patients were asked to return 2 to 3 days after enrollment (early follow-up visit), 5 to 9 days after treatment (1-week posttreatment visit), and 4 to 6 weeks after treat-ment (5-week posttreatment visit).…”

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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, fluoroquinolones appear to be highly efficient given as a 3-day regimen. Hooton et al (4) Two previous studies showed lower cure rates when a single-dose ciprofloxacin (2) or ofloxacin (4) was given to women with Staphylococcus saprophyticus bacteriuria. In our study, one of two women with S. saprophyticus bacteriuria treated with cefixime and all three women treated with ofloxacin failed.…”

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confidence: 99%

Double-blind study comparing 3-day regimens of cefixime and ofloxacin in treatment of uncomplicated urinary tract infections in women

Raz

Rottensterich

Leshem

et al. 1994

This double-blind randomized study compared 3-day regimens of cefixime (400 mg once daily) and ofloxacin (200 mg twice a day) in the treatment of urinary tract infections in women. The respective clinical cure rates for the two groups of women were 89 and 92% after 7 days and 81 and 84% after 4 weeks. The respective microbiological cure rates (free of bacteriuria) for the two groups of women were 83 and 86% after 7 days and 77 and 80% after 28 days. A 3-day cefixime regimen seems to be as efficient as a 3-day ofloxacin regimen in the treatment of uncomplicated cystitis in women.A 3-day regimen of antibiotics appears to be the optimal treatment for uncomplicated cystitis in women. This regimen may be associated with cure rates comparable to those achieved with longer courses of therapy, along with an incidence of adverse effects as low as that seen with single-dose therapy (5).Short-course, single-dose or 3-day regimens of cotrimoxazole and quinolones are as effective as longer courses of therapy (4); however, beta-lactam antibiotics were more effective when administered for 5 or more days than when given as a 3-day or single-dose course (6).Cefixime is an oral cephalosporin, with a broad antibacterial spectrum against most community-acquired uropathogens. Peak concentrations in serum of 3 to 4 ,ug/ml are achieved 3 to 4 h following a 400-mg tablet. The half-life in serum of 3 to 4 h is substantially longer than that of other oral beta-lactam antibiotics. In addition, urinary concentrations after a single daily dose of 400 mg are well above the MICs for 90% of the most common urinary pathogens (1).The aim of the present study was to evaluate the efficacy of a 3-day regimen of cefixime and to compare it with a similar regimen of ofloxacin in the treatment of women with uncomplicated cystitis.Women fixime once daily plus placebo, and the ofloxacin-treated patients received 200 mg of ofloxacin twice a day. Both regimens were given for 3 days.Each patient was monitored clinically and bacteriologically at 7 and 28 days. The presence of the same microorganism after cessation of treatment (follow-up after 7 days) was defined as a failure. Relapse was defined as a positive culture with the same pathogen after a previous negative culture.Side effects were recorded by asking each woman at the second follow-up visit about the appearance of any symptoms during the last week and specifically about symptoms related to the drug treatment, such as abdominal disturbances, nausea, vomiting, rash, fever, etc.Statistical analysis was performed by the chi-square test with the Yates' correction where appropriate, and P values of 0.05 were considered statistically significant.The size of the study group was set so that a clinically significant difference of 20% or more between the efficacy of treatment with cefixime compared with that with ofloxacin, with a two-sided type I error (alpha) of 0.05 and type II error (beta) of 0.2, could be detected.A total of 106 women were included in the study. Of the 106 women, 54 received cefixime and...

“…For other antimicrobial agents effective as short courses of therapy, 3 days of therapy has been suggested to be appropriate (6,8,9,16). For the fluoroquinolone antimicrobial agents, in particular, 3 days of therapy seems necessary because of the high failure rates of single-dose therapy of infection with Staphylococcus saprophyticus, the second most frequent infecting organism in this syndrome (5,8,17). In Canada, norfloxacin has been marketed with an indication for 3 days of therapy for uncomplicated urinary tract infections, making it the only antimicrobial agent marketed with an indication for a short course of therapy for this syndrome.…”

mentioning

confidence: 99%

Treatment of acute uncomplicated urinary tract infections with 3 days of lomefloxacin compared with treatment with 3 days of norfloxacin

Nicolle

Dubois

Martel

et al. 1993

The bacteriologic and clinical efficacies of 3 days of lomefloxacin therapy were compared with those of 3 days of norfloxacin therapy for the treatment of acute uncomplicated urinary tract infections in a prospective, randomized, double-blind study. One hundred sixty-four subjects were enrolled at five Canadian centers; 84 received lomefloxacin, and 80 received norfloxacin. Escherichia coli (84%) and Staphylococcus saprophyticus (11%) were the most common organisms isolated. Forty subjects (24%) had low quantitative counts in their pretherapy urine specimens. In the intent-to-treat analysis, 76 lomefloxacin subjects (91%) and 76 norfloxacin subjects (95%) were cured or improved at follow-up 5 to 9 days posttreatment and 73 (87%) and 71 (89%o) subjects from the lomefloxacin and norfloxacin groups, respectively, were cured or improved at 4 to 6 weeks posttreatment. Bacteriologic eradication occurred in 61 of 63 lomefloxacin subjects (97%) with .108 CFU/liter in their pretherapy specimens and 56 of 59 norfloxacin subjects (95%) at 5 to 9 days and 55 (87%) and 53 (90%o) subjects from the lomefloxacin and norfloxacin groups, respectively, at 4 to 6 weeks. There were no statistically significant differences in outcome. Adverse effects which were potentially related to the study medications were reported by 26% of the subjects who received lomefloxacin and 25% of the subjects who received norfloxacin.