investigation on blood-levels and excretion of vancomycin (antibiotictherapy) in dependency on certain parameters (renal function, age, sexetc.) and the kind of infusion. Investigation on the influence of vancomycinon the gut flora
Phase 1
- Conditions
- In patients who receive an antibiotic therapy with vancomycin i.v. (because of an infection) blood-, urine and stool samples are taken at certain time points and data on the pharmakokinetic of vancomycin are raised.Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2015-003171-29-DE
- Lead Sponsor
- niversitätsklinikum Tübingen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Adult hospitalized patients of more than 18 years that are not pregnant and not treated with renal replacement treatment who need a treatment with vancomycin according to their attending physician.
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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
Exclusion Criteria
Exclusion criteria are
age of less than 18 years;
estimated life-expectance of < 48 hours due to major co-morbid conditions;
pregnancy
gE-mediated allergy to vancomycin
patients not giving informed consent
hemoglobin < 10 g/dl
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: getting information/prospective data on the pharmkokinetics of vancomycin to develop a new dose calculator of with which - in dependency on age, renal function, weight etc. of the patient - the optimal dosage of vancomycin can be calculated;Secondary Objective: developing a calculator with which the optimal dosing of vancomycin (an antibiotic) can be calculated in dependency on age of the patient, his renal function etc.<br>;Primary end point(s): no primary endpoints;Timepoint(s) of evaluation of this end point: keine primären Endpunkte
- Secondary Outcome Measures
Name Time Method Secondary end point(s): no secondary endpoints;Timepoint(s) of evaluation of this end point: no secondary endpoints