Randomised Controlled Trial of Meropenem versus Cefmetazole for definitive treatment of bloodstream infections due to ESBL- producing Escherichia coli
- Conditions
- bloodstream infections due to ESBL- producing Escherichia coli
- Registration Number
- JPRN-UMIN000049016
- Lead Sponsor
- ational Center for Global Health and Medicine, Disease Control and Prevention Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 169
Not provided
1) Participation in other intervention studies 2) History of allergy to cefmetazole or carbapenem 3) Bacteremia due to multiple bacteria (excluding skin contaminants) 4) Patients expected to die within 4 days after randomization (randomized day = day 1) 5) Patients who are expected to be difficult to follow during the first 30 days after randomization (day of randomization = day 1) 6) Pregnant women and breastfeeding women 7) Patients on dialysis or patients whose creatinine clearance (based on Cockcroft-Gault formula) is less than 10ml/min 8) Patients expected to receive additional antibiotics active against Gram-negative bacilli by day 5 after randomization (excluding sulfamethoxazole and trimethoprim for prevention of Pneumocystis pneumonia) (day of randomization = Day 1) 9) Confirmed or strongly suspected carbapenemase-producing or AmpC-producing E. coli from blood culture (e.g. carbapenemase-positive with carbapenemase detection kit or AmpC pattern-positive with beta-lactamase detection kit, carbapenemase screening medium positive) 10) Patients currently using sodium valproate or expected to use it by day 5 after randomization (randomized day = day 1) 11) Persons who are judged inappropriate for inclusion in the research by the principal investigator at each test site
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method