Investigation of Caspofungin Plasma Concentration and Pharmacokinetic for the Improvement of the Antifungal Therapy in Patients of Surgical Intensive Care Unit - CASPO-PK-Intensiv
- Conditions
- hospitalised patients
- Registration Number
- EUCTR2006-001146-13-DE
- Lead Sponsor
- niversity Hospital of Heidelberg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
Age > 18 years
Patients of intensive care unit with proven or probable invasive fungal infections caused by candida or aspergillus species who are treated with Caspofungin as a regular treatment during hospitalisation.
Precautions, special warnings, interactions containing in the Fachinformation (SPC) have to be followed.
Decision for dosage and dose adjustment because of insufficient activity, adverse effect, interactions, organ dysfunctions or body weight should only be made after benefit-risk-estimation.
concomitant application of Ciclosporin A, Tacrolimus or Rifampicin and close monitoring of drug levels and liver functions.
Voluntarily signed informed consent after full explanation of the study to the patients.
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) yes
F.1.3.1 Number of subjects for this age range
Kinetic:
Hypersensitivity against Caspofunginacetate or other constituents
Patients with severe liver dysfunction
concomitant application of Ciclosporin A, Tacrolimus or Rifampicin without close monitoring of drug levels and liver functions.
Patients who get Caspofungin less than 10 days.
women
In case of contraindications containing in the Fachinformation (SPC).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method