Sepsis and acute renal failure (ARF) are pathological entities that commonly co-exist in patients admitted to intensive care. Antibiotic dosing in septic patients with ARF can be complicated and may result in either underdosing, causing treatment failure and antibiotic resistance, or overdosing resulting in drug toxicity. The aim of this study is to collect pharmacokinetic data for evaluating underdosing or overdosing of linezolid and meropenem in patients receiving renal replacement therapy.
Conditions
Interventions
Trade Name: Zyvoxid 600 mg (Pfizer)
Product Name: Zyvoxid 600 mg
Pharmaceutical Form: Intravesical solution
INN or Proposed INN: Linezolid
CAS Number: 165800-03-3
Other descriptive name: LINEZOLID
Con
Sponsors
Department of Pharmacy Unversitätsmedizin Mainz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients have to be older than 18 years - continuous renal replacement therapy - antibiotic treatment with linezolid and/or meropenem - written consent to the clinical trial by the patient or the legal representative 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 20
Exclusion criteria
Exclusion criteria: - patients younger than 18 years - no continuous renal replacement therapy - no antibiotic treatment with linezolid and/or meropenem - unreadiness to the clinical trial - participation in an other clinical trial - pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this trial is to evaluate the practiced antibiotic dosing of linezolid and meropenem in patients receiving continuous renal replacement therapy.;Secondary Objective: Secondary objective of the trial is to increase patient's security by therapeutic drug monitoring.;Primary end point(s): collected blood- and dialysate-samples over 24 hours under continuous renal replacement therapy;Timepoint(s) of evaluation of this end point: 24 hours after drawing the first sample | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The results from the analysis are communicated to the treating physician. He can now optimize the antibiotic dosing if necessary.;Timepoint(s) of evaluation of this end point: 24 hours after analysis of the samples | — |
Countries
Germany
Contacts
Public ContactPharmacy
Department of Pharmacy Univeritätsmedizin Mainz
Outcome results
None listed