JPRN-UMIN000049016RecruitingUnknown
Randomised Controlled Trial of Meropenem versus Cefmetazole for definitive treatment of bloodstream infections due to ESBL- producing Escherichia coli - CEFMEC Trial
ational Center for Global Health and Medicine, Disease Control and Prevention Center0 sites169 target enrollmentStarted: September 26, 2022Last updated:
Trial Snapshot
- Phase
- Unknown
- Status
- Recruiting
- Sponsor
- Enrollment
- 169
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18years-old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- Not provided
Exclusion Criteria
- •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
Investigators
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