investigation on blood-levels and excretion of vancomycin (antibiotic therapy) in dependency on certain parameters (renal function, age, sex etc.) and the kind of infusion. Investigation on the influence of vancomycin on the gut flora

The correlation between vancomycin AUC and trough levels during intermittent dosing of vancomycin and plateau levels during continuous infusion - Pharmacokinetic evaluation of Vancomycin and the influence of the antibiotic therapy on the microbioma-

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003171-29-DE

Enrollment

Registered

2015-11-04

Start date

2015-12-17

Completion date

Unknown

Last updated

2021-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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.

Interventions

Product Name: Vancomycin Pharmaceutical Form: Powder for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

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: 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

Design outcomes

Primary

Measure	Time frame
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. ;Primary end point(s): no primary endpoints;Timepoint(s) of evaluation of this end point: keine primären Endpunkte	—

Measure

Time frame

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. ;Primary end point(s): no primary endpoints;Timepoint(s) of evaluation of this end point: keine primären Endpunkte

—

Secondary

Measure	Time frame
Secondary end point(s): no secondary endpoints;Timepoint(s) of evaluation of this end point: no secondary endpoints	—

Countries

Germany

Contacts

Public ContactEvelina Tacconelli

Universitätsklinikum Tübingen, Medizinische Klinik I

stefanie.doebele@med.uni-tuebingen.de

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026