Investigation of the blood levels of selected antibiotics in critically ill patients undergoing dialysis
- Conditions
- 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.Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2013-000899-16-DE
- Lead Sponsor
- Department of Pharmacy Unversitätsmedizin Mainz
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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