Pharmacokinetics of ertapenem in patients with severe sepsis and intraabdominal infectio
- Conditions
- Severe sepsis caused by intraabdominal infection either peritonitis or pancreatitis
- Registration Number
- EUCTR2009-015948-42-EE
- Lead Sponsor
- niversity of Tartu, Faculty of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 8
Inclusion Criteria
adult aged 18-65 years
severe sepsis, according to international criteria
peritonitis and/or severe pancreatitis
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
renal dysfunction, defined as creatinine clearance less than 30 ml/min calculated using Cockroft-Gault formula
morbidly obese patients with BMI over 35 kg/m2
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To study penetration of ertapenem into abdominal cavity during severe sepsis caused by intrabdominal infection;Secondary Objective: To relate measured intraabdominal concentration to pharmacodynamic measure of antimicrobial efficiency: time over MIC.;Primary end point(s): concentration of ertapenem in abdominal cavity
- Secondary Outcome Measures
Name Time Method