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J Antimicrob Chemother. 2014 Jun;69(6):1675-80. doi: 10.1093/jac/dku014. Epub 2014 Feb 6.

Treatment of acute uncomplicated cystitis with faropenem for 3 days versus 7 days: multicentre, randomized, open-label, controlled trial.

Author information

1
Department of Urology, University of Occupational and Environmental Health, Kitakyushu, Japan hamaryo@med.uoeh-u.ac.jp.
2
Division of Urology, Department of Surgery Related, Kobe University Graduate School of Medicine, Kobe, Japan.
3
Blood Purification Centre, Kagoshima University Hospital, Kagoshima, Japan.
4
Department of Urology, School of Medicine, Gifu University, Gifu, Japan.
5
Department of Urology, School of Medicine, Sapporo Medical University, Sapporo, Japan.
6
Department of Urology, Hiroshima University Institute of Biomedical and Health Sciences, Hiroshima, Japan.
7
Department of Urology, Jikei University Katsushika Medical Centre, Tokyo, Japan.
8
Department of Urology, Hyogo College of Medicine, Nishinomiya, Japan.
9
Division of Integrated Medical Education, Department of Social/Community Medical and Health Science, Kobe University Graduate School of Medicine, Kobe, Japan.
10
Department of Urology, University of Occupational and Environmental Health, Kitakyushu, Japan.

Abstract

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.

KEYWORDS:

Escherichia coli; RCTs; faropenem sodium; optimal duration

PMID:
24508899
DOI:
10.1093/jac/dku014
[Indexed for MEDLINE]

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