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

Abstract

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...

Cefpodoxime-Proxetil versus Trimethoprim-Sulfamethoxazole for Short-Term Therapy of Uncomplicated Acute Cystitis in Women

“…At 28 days after the discontinuation of therapy, clinical cures were observed in 87.3 and 85% of the patients in the cefpodoxime-proxetil and TMP-SMX arms, respectively, and the rates of overall bacteriological eradication were 86 and 84% in the two arms, respectively. Although there is some evidence that short-term ciprofloxacin therapy may be more efficient for the eradication of urinary pathogens (11), the regimens used in the present study were better than those obtained with a short course of cefixime (18) and were similar to those obtained by Cox et al (4) when cefpodoxime-proxetil was administered for 7 days (14). Two double-blind multicenter trials (4) compared cefpodoxime-proxetil (100 mg twice daily) with cefaclor (250 mg three times daily) or amoxicillin (250 mg three times daily) in 463 evaluable adult patients with uncomplicated UTIs.…”

“…In the latter study, clinical cure and improvement were registered in 84.8 and 95.2% of the patients, respectively, at 7 to 9 days posttherapy, whereas bacteriuria (Ͻ10 3 /ml) was eliminated from 80.3 and 89.1% of the evaluable patients receiving cefuroxime-axetil and ofloxacin, respectively, with no statistically significant difference between treatment groups. On the other hand, in a double-blind randomized study, a 3-day regimen of 400 mg of cefixime once daily was as effective as a 3-day regimen of 200 mg of ofloxacin twice a day for the treatment of 99 women with uncomplicated cystitis (18). In the latter study, the respective clinical cure rates were 89 and 92% at early follow-up and 81 and 84% at late follow-up, with bacteriological cure rates of 83 and 86%, respectively, 7 days after the discontinuation of therapy and 77 and 80%, respectively, 4 weeks after the discontinuation of therapy (18).…”

“…On the other hand, in a double-blind randomized study, a 3-day regimen of 400 mg of cefixime once daily was as effective as a 3-day regimen of 200 mg of ofloxacin twice a day for the treatment of 99 women with uncomplicated cystitis (18). In the latter study, the respective clinical cure rates were 89 and 92% at early follow-up and 81 and 84% at late follow-up, with bacteriological cure rates of 83 and 86%, respectively, 7 days after the discontinuation of therapy and 77 and 80%, respectively, 4 weeks after the discontinuation of therapy (18).…”

Treatment of Community-Acquired Acute Uncomplicated Urinary Tract Infection With Sparfloxacin Versus Ofloxacin

“…Furthermore, when the effects of treatment were evaluated 5 to 9 days after therapy, both drugs provided marked improvement or relief from the signs and symptoms of UTI in more than 92% of all patients treated, including those who were not evaluable because of low urine colony counts (Ͻ10 5 CFU/ml) at study entry (2). The clinical and bacteriologic outcome rates in the ofloxacin arm of this study are similar to those reported previously for the drug used for this indication (5,24). Clinical findings and bacteriologic results in this study were in agreement for all but a few patients; one in each group was deemed a success clinically but had a bacteriologic response of failure, while three in the sparfloxacin group and seven in the ofloxacin group had positive bacteriologic responses but were designated clinical failures.…”

“…For example, although mean ages in such studies have varied widely, from 24 to more than 48 years (5,6,10,24,28), the mean age of 36 years in this study is typical of the narrower range of 30 to 40 years for multicenter studies with an upper age limit for enrollment (7,12,19,20) and is appropriate for the disease population (2). In addition, the organisms isolated here, predominantly E. coli (188 of 219; 85.8%) and S. saprophyticus (4.6%), are consistent with the spectrum of pathogens expected in acute uncomplicated UTI (4,31), although a relatively high percentage of E. faecalis (5.0%), which is more commonly associated with nosocomial UTIs (8), was also found.…”