3-day vs. 7-day Faropenem Regimen for Treatment of Acute Uncomplicated Cystitis

calendar
23 Oct, 23

 

Introduction

The increasing prevalence of resistant bacteria such as fluoroquinolone-resistant or extended-spectrum b-lactamase-producing strains in pathogens causing acute uncomplicated cystitis has been of concern. Faropenem sodium is a penem antimicrobial that demonstrates a wide antimicrobial spectrum against both aerobic and anaerobic bacteria. It is stable against several b-lactamases.

Aim

To evaluate the efficacy of faropenem against cystitis and to determine the optimal faropenem treatment duration.

Patient Profile

  • Women aged ≥20 years, with any cystitis symptoms, such as micturition pain, urinary frequency, urge to urinate, or lower abdominal pain with pyuria and bacteriuria
  • Target bacteria: Staphylococcus spp., Enterococcus faecalis, Streptococcus agalactiae and Enterobacteriaceae

Methods

  • Multicentre, randomized, open-label, controlled study comparing 3- and 7-day administration regimens of faropenem
  • Treatment: 200 mg faropenem sodium tablet administered three times daily (600 mg/day) for 3 or 7 days

Study endpoints

  • Primary: Microbiological outcome 5–9 days after treatment completion
  • Second endpoint: Clinical outcome 5–9 days or 4–6 weeks after treatment

Results

  • E. coli accounted for 73.9% of the isolated bacterial strains. Highest faropenem MIC was 2 mg/L and this strain was eradicated after 7 days of treatment
  • Clinical efficacies 5-9 days after treatment in 3-days and 7-days groups: 76.7% vs. 80.2% (P=0.695)
  • Clinical efficacies 4-6 weeks after treatment completion in 3-days and 7-days groups: 46.2% vs. 50.0% (P=0.717)

Table 1: Comparison of Study Endpoints

 

Microbiological evaluation

Clinical evaluation

5-9 days after treatment

 

 

3-day treatment group

Eradication 58.9%

Cure 76.7%

 

Persistence 20.5%

Failure 16.4%

 

Replaced 8.2%

 

7-day treatment group

Eradication 66.7%

Cure 80.2%

 

Persistence 6.2%

Failure 6.2%

 

Replaced 7.4%

 

4-6 weeks after treatment

 

 

3-day treatment group

Eradication 40.4%

Cure 46.2%

 

Replaced 5.8%

Failure 5.8%

 

Reinfection 3.8%

 

7-day treatment group

Eradication 38.6%

Cure 50.0%

 

Replaced 5.7%

Failure 1.4%

 

Reinfection 4.3%

 

 

Safety: Adverse events due to faropenem were reported in 9.5% of participants and most common adverse event was diarrhoea.

Conclusion

  • Optimal regimen of faropenem for cystitis was determined to be 200 mg three times daily for 7 days
  • E. coli strains resistant to fluoroquinolones or cephalosporins showed high susceptibility to faropenem

Reference

J Antimicrob Chemother 2014; 69: 1675–1680

Introduction

The increasing prevalence of resistant bacteria such as fluoroquinolone-resistant or extended-spectrum b-lactamase-producing strains in pathogens causing acute uncomplicated cystitis has been of concern. Faropenem sodium is a penem antimicrobial that demonstrates a wide antimicrobial spectrum against both aerobic and anaerobic bacteria. It is stable against several b-lactamases.

Aim

To evaluate the efficacy of faropenem against cystitis and to determine the optimal faropenem treatment duration.

Patient Profile

  • Women aged ≥20 years, with any cystitis symptoms, such as micturition pain, urinary frequency, urge to urinate, or lower abdominal pain with pyuria and bacteriuria

  • Target bacteria: Staphylococcus spp., Enterococcus faecalis, Streptococcus agalactiae and Enterobacteriaceae

Methods

  • Multicentre, randomized, open-label, controlled study comparing 3- and 7-day administration regimens of faropenem

  • Treatment: 200 mg faropenem sodium tablet administered three times daily (600 mg/day) for 3 or 7 days

Study endpoints

  • Primary: Microbiological outcome 5–9 days after treatment completion

  • Second endpoint: Clinical outcome 5–9 days or 4–6 weeks after treatment

Results

  • E. coli accounted for 73.9% of the isolated bacterial strains. Highest faropenem MIC was 2 mg/L and this strain was eradicated after 7 days of treatment

  • Clinical efficacies 5-9 days after treatment in 3-days and 7-days groups: 76.7% vs. 80.2% (P=0.695) 

  • Clinical efficacies 4-6 weeks after treatment completion in 3-days and 7-days groups: 46.2% vs. 50.0% (P=0.717) 

Table 1: Comparison of Study Endpoints

 
 
 
 

 

 
 
 
 

Microbiological evaluation

 
 
 
 

Clinical evaluation

 
 
 
 

5-9 days after treatment

 
 
 
 

 

 
 
 
 

 

 
 
 
 

3-day treatment group

 
 
 
 

Eradication 58.9%

 
 
 
 

Cure 76.7%

 
 
 
 

 

 
 
 
 

Persistence 20.5%

 
 
 
 

Failure 16.4%

 
 
 
 

 

 
 
 
 

Replaced 8.2%

 
 
 
 

 

 
 
 
 

7-day treatment group

 
 
 
 

Eradication 66.7%

 
 
 
 

Cure 80.2%

 
 
 
 

 

 
 
 
 

Persistence 6.2%

 
 
 
 

Failure 6.2%

 
 
 
 

 

 
 
 
 

Replaced 7.4%

 
 
 
 

 

 
 
 
 

4-6 weeks after treatment

 
 
 
 

 

 
 
 
 

 

 
 
 
 

3-day treatment group

 
 
 
 

Eradication 40.4%

 
 
 
 

Cure 46.2%

 
 
 
 

 

 
 
 
 

Replaced 5.8%

 
 
 
 

Failure 5.8%

 
 
 
 

 

 
 
 
 

Reinfection 3.8%

 
 
 
 

 

 
 
 
 

7-day treatment group

 
 
 
 

Eradication 38.6%

 
 
 
 

Cure 50.0%

 
 
 
 

 

 
 
 
 

Replaced 5.7%

 
 
 
 

Failure 1.4%

 
 
 
 

 

 
 
 
 

Reinfection 4.3%

 
 
 
 

 

 

Safety: Adverse events due to faropenem were reported in 9.5% of participants and most common adverse event was diarrhoea.

Conclusion

  • Optimal regimen of faropenem for cystitis was determined to be 200 mg three times daily for 7 days

  • E. coli strains resistant to fluoroquinolones or cephalosporins showed high susceptibility to faropenem

Reference

J Antimicrob Chemother 2014; 69: 1675–1680