All subjects are patients of a SICU. Apache Score > 30. Infection treatment or prophylaxis.
Conditions
Interventions
Trade Name: NOXAFIL
40 mg/ml Suspension
105 ml
Product Name: NOXAFIL (R) 40mg/ml Suspension
Pharmaceutical Form: Oral suspension
Sponsors
University Hospital Heidelberg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: age > 18 years indication for therapeutic use as described in the product information ALL SUBJECT PARTICIPATE IN THE TRIAL BECAUSE THEY GET POSACONAZOLE, NOT REVERSE! subject receives posaconazole via naso-gastric tube sex: male sex: female, postmenopausal minimum 2 years patients who are not capable giving consent personally are also able to participate in the trial because it's impossible to get a sufficant number of subject who can consent (compare AMG § 41 (3) 3). 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
Exclusion criteria
Exclusion criteria: Patients with hypersensitivity against posaconazole in product information described contraindications women with childbearing potential children and youth pregnancy breast-feeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: pharmakokinetic of posaconazole in SICU patients receiving the substance via gastric tube;Secondary Objective: appraisal of the efficacy;Primary end point(s): There's no specified end point, the observation period will be maximum ten days under posaconazole therapy and maximum two days after the therapy. It's an ancompanying pharmacokinetic-study | — |
Countries
Germany
Outcome results
None listed