Pharmakokinetik von Posaconazol verabreicht über Magensonde - POLICE-Studie (POsaconazoLe via gastrIC tubE) - POLICE
- Conditions
- All subjects are patients of a SICU. Apache Score > 30. Infection treatment or prophylaxis.
- Registration Number
- EUCTR2007-002755-16-DE
- Lead Sponsor
- niversity Hospital Heidelberg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 15
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
Patients with hypersensitivity against posaconazole
in product information described contraindications
women with childbearing potential
children and youth
pregnancy
breast-feeding women
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