Infections caused by fosfomycin-sensitive pathogens Acute or acute-to-chronic renal failure requiring continuous dialysis treatment
Conditions
Interventions
Group 1: In patients who receive the antibiotic fosfomycin due to an infection and require dialysis treatment (CVVHD) due to renal insufficiency, the plasma concentrations of fosfomycin are determined
Sponsors
Infectopharm Arzneimittel und Consilium GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Written consent of the patient or his legal guardian, patients > 18 years, acute renal failure with indication for continuous renal replacement therapy, patient already receives fosfomycin or the dose is planned for medical indication, Central venous catheter for taking blood samples have already been placed for medical indication, BMI < 35, for women of childbearing potential: negative pregnancy test, or surgical sterilization or contraceptive use during the examination or min. 2 years after postmenopause.
Exclusion criteria
Exclusion criteria: Refusal by the patient, contraindications or known intolerance to any of the drugs or procedures used, pre-existing conditions or patient circumstances that make a patient's examination impossible or meaningless (eg, dementia, psychiatric disorders, poor speech understanding or speaking ability), body mass index > 35, pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration course of fosfomycin with and without multifiltration dialysis 1. before first start 2. 15 minutes after first start 3. 30 min after first start 4. 60 min after first start 5. 90 minutes after first start 6. 120 min after first start 7. 180 minutes after first start 8. 240 minutes after first start 9. 300 min after first start 10. 360 minutes after first start | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in distribution volumes and clearance values; Correlation between fosfomycin dosage and plasma concentrations taking into account the cofactors: acute renal failure, multifiltration dialysis, fosfomycin concentration in dialysis filtrate. Endpoints are calculated after completion of all plasma measurements within a pharmacokinetic model. | — |
Countries
Germany
Contacts
Public ContactTobias Hüppe
Center of Breath Research Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie Universitätsklinikum des Saarlandes
Outcome results
None listed