To develop a population pharmacokinetic model of teicoplanin in Intensive Care and Haematology patients for the purpose of dose individualization using therapeutic drug monitoring.
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To develop a population pharmacokinetic model of teicoplanin in Intensive Care
and Haematology patients
Secondary outcome
- To estimate the influence of renal function on the teicoplanin clearance
using different renal biomarkers.
- To investigate the impact of serum albumin on bound and unbound teicoplanin
concentrations.
- To develop a limited sampling strategy for estimating the area under the
concentration time curve of teicoplanin.
Background summary
Infections with coagulase-negative staphylococci (CNS) or methicillin resistant
and susceptible Staphylococcus aureus (MRSA/MSSA) strains indicates poor
prognosis and increased mortality. The glycopeptides teicoplanin and vancomycin
are drugs of first choice for treatment of selected gram positive infections.
Outbreaks of infection with multi-drug resistant bacteria plague modern ICUs.
To eradicate these strains successfully without development of resistance,
optimized dosing is pivotal. Wide application of high dosage of vancomycin
limit its use as high exposure is associated with nephrotoxicity in up to 20%
of the patients. Teicoplanin seems to be able to replace vancomycine as the
best candidate to fight infections with CNS,
MSSA and MRSA, as it is considered equipotent to vancomycin, but associated
with less drug-induced nephrotoxicity.
Therapeutic drug monitoring (TDM) is currently not routine practice with
teicoplanin, despite the fact that it has been shown that long-term treatment
at suboptimal concentrations of teicoplanin is a risk factor for emergence of
de-novo glycopeptide-resistant strains. In conjunction it will limit toxicity
due to toxic concentrations.
To optimize teicoplanin dosing we have to gain knowledge on the
pharmacokinetics of teicoplanin in critically ill patients and to characterize
the influence of renal function on exposure.
Study objective
To develop a population pharmacokinetic model of teicoplanin in Intensive Care
and Haematology patients for the purpose of dose individualization using
therapeutic drug monitoring.
Study design
Prospective, observational, pharmacokinetic study
Study burden and risks
We consider the extra burden from participating in the planned study
negligible. The extra intervention compared to routine care consits os sampling
a minimum amount of extra blood. A peripheral catheter is placed, which is in
place during the course of the study, so that repeated puncture is not
necessary.
Geert Grooteplein 10
Nijmegen 6525 GA
NL
Geert Grooteplein 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
1. The patient is admitted to the ICU of the haematology department
2. The patient is at least 18 years of age on the day of inclusion
3. Is treated with teicoplanin as a part of standard care
4. Is able and willing to sign the Informed Consent form
Exclusion criteria
1. Has previously participated in this study
2. Patient receives any form of RRT other than continuous venovenous
hemofiltration (CVVH).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL75069.091.20 |
| Other | PLATO |