what are the optimal doses of cefuroxime for cirrhotic patients?
- Conditions
- Cirrhotic patients with infection requiring treatment with cefuroximeMedDRA version: 16.0Level: LLTClassification code 10024678Term: Liver failureSystem Organ Class: 100000004871Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2013-003349-41-BE
- Lead Sponsor
- Erasme hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
All patients aged more than 18 year-old with cirrhosis child A (<7), B (7-9) or C (10-15), without liver transplantation, hospitalized and treated with cefuroxime for a suspected or confirmed infection will be included
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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
Exclusion Criteria
patients less than 18 year-old, pregnant women, patients with body mass index < 15 or > 30 kg/m².
Patients infected with HIC and hepatitis C
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the pharmacokinetics of cefuroxime in cirrhotic patients;Secondary Objective: not applicable;Primary end point(s): Study of pharmacokinetic parameters;Timepoint(s) of evaluation of this end point: NA
- Secondary Outcome Measures
Name Time Method Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA