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Treatment of acute uncomplicated cystitis with faropenem for 3 days versus 7 days: multicentre, randomized,
Ryoichi Hamasuna1, Kazushi Tanaka2, Hiroshi Hayami3
1Department of Urology, University of Occupational and Environmental Health, Kitakyushu, Japan hamaryo@med.uoeh-u.ac.jp.
Objectives:
The increasing prevalence of resistant bacteria such as fluoroquinolone-resistant or extended-spectrum β-lactamase-producing strains in pathogens causing acute uncomplicated cystitis has been of concern in Japan. Faropenem sodium is a penem antimicrobial that demonstrates a wide antimicrobial spectrum against both aerobic and anaerobic bacteria. It is stable against a number of β-lactamases.
Methods:
We compared 3 and 7 day administration regimens of faropenem in a multicentre, randomized, open-label, controlled study.
Results:
In total, 200 female patients with cystitis were enrolled and randomized into 3 day (N = 97) or 7 day (N = 103) treatment groups. At the first visit, 161 bacterial strains were isolated from 154 participants, and Escherichia coli accounted for 73.9% (119/161) of bacterial strains. At 5-9 days after the completion of treatment, 73 and 81 patients from the 3 day and 7 day groups, respectively, were evaluated by intention-to-treat analysis; the microbiological efficacies were 58.9% eradication (43/73), 20.5% persistence (15/73) and 8.2% replaced (6/73), and 66.7% eradication (54/81), 6.2% persistence (5/81) and 7.4% replaced (6/81), respectively (P = 0.048). The clinical efficacies were 76.7% (56/73) and 80.2% (65/81), respectively (P = 0.695). Adverse events due to faropenem were reported in 9.5% of participants (19/200), and the most common adverse event was diarrhoea.
Conclusions:
The 7 day regimen showed a superior rate of microbiological response. E. coli strains were in general susceptible to faropenem, including fluoroquinolone- and cephalosporin-resistant strains.
Insights
A 7-day faropenem regimen demonstrated superior microbiological response for acute uncomplicated cystitis compared to a 3-day regimen. Faropenem effectively treated E. coli, including resistant strains.
Area of Science:
- Infectious Diseases
- Pharmacology
- Microbiology
Background:
- Rising prevalence of antibiotic-resistant bacteria, including fluoroquinolone-resistant and extended-spectrum β-lactamase-producing strains, is a concern for acute uncomplicated cystitis in Japan.
- Faropenem sodium, a penem antimicrobial, offers a broad spectrum against aerobic and anaerobic bacteria and stability against various β-lactamases.
Purpose of the Study:
- To compare the efficacy and safety of 3-day versus 7-day administration regimens of faropenem for acute uncomplicated cystitis.
- To evaluate faropenem's effectiveness against common uropathogens, including resistant strains.
Main Methods:
- A multicenter, randomized, open-label, controlled study comparing 3-day and 7-day faropenem treatment regimens.
- 200 female patients with cystitis were enrolled and randomized.
- Microbiological and clinical efficacies were assessed post-treatment.
Main Results:
- The 7-day regimen achieved a significantly higher microbiological eradication rate (66.7%) compared to the 3-day regimen (58.9%) (P=0.048).
- Clinical efficacy rates were comparable between the 3-day (76.7%) and 7-day (80.2%) groups.
- Adverse events were reported in 9.5% of patients, with diarrhea being the most common.
Conclusions:
- A 7-day faropenem regimen is superior for microbiological response in acute uncomplicated cystitis.
- Faropenem demonstrated susceptibility against Escherichia coli strains, including those resistant to fluoroquinolones and cephalosporins.
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