Cirrhotic patients with infection requiring treatment with cefuroxime MedDRA version: 16.0 Level: LLT Classification code 10024678 Term: Liver failure System Organ Class: 100000004871
Conditions
Interventions
Trade Name: Zinacef
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: Zinacef
Current Sponsor code: Zinacef
Other descriptive name: CEFUROXIME SODIUM STERILE
Concentration unit
Sponsors
Erasme hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All patients aged more than 18 year-old with cirrhosis child A (=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: patients less than 18 year-old, pregnant women, patients with body mass index 30 kg/m². Patients infected with HIC and hepatitis C
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA | — |
Countries
Belgium
Contacts
Public ContactMaya Hites
Erasme Hospital
Outcome results
None listed