Invasive fungal infection treated with an echinocandin and indication for paracentesis, thoracentesis, bile deviation or sampling, lumbar puncture or VAC therapy
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: • Age of 18 years or over • Running echinocandin therapy (caspofungin, micafungin or anidulafungin) within the last 30 days • Indication for paracentesis (or peritoneal drainage), thoracentesis (or pleural drainage), lumbar puncture, bile deviation (via drainage or T-tube) or sampling by endoscopy or VAC® therapy 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 126 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 126
Exclusion criteria
Exclusion criteria: • Lacking indication for echinocandin therapy • Contraindication for echinocandin therapy • Lacking indication or contraindication for paracentesis (or peritoneal drainage), thoracentesis (or pleural drainage), lumbar puncture, bile deviation (via drainage or T-tube) or sampling by endoscopy or VAC® therapy • Age below 18 years • Lacking consent of a competent patient, lacking post-hoc consent of a patient who had been incompetent at the time of sampling and has gained competence (In the latter case the respective data will not be used.) • Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Quantification of caspofungin, anidulafungin and micafungin in ascites, pleural effusion, bile, wound secretion and cerebrospinal fluid (CSF) after administration of standard doses. Information on distribution of echinocandins in relevant body fluids. ;Secondary Objective: Clarifying whether sufficient echinocandin levels can be reached with therapeutic doses at various relevant target sites. Optimising choice and dosage of antimycotics during treatment of difficult to treat infections and will prompt further clinical trials ;Primary end point(s): Concentrations of caspofungin, anidulafungin and micafungin in ascites, pleural effusion, bile, wound secretion and cerebrospinal fluid (CSF) after administration of standard doses;Timepoint(s) of evaluation of this end point: 1, 4, 8, 12, 18, 24 hours after start of echinocandin infusion or single time within this period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Relation between echinocandin concentrations in body fluids and MIC values for relevant fungal pathogens Eventual differences in penetration of the three different echinocandins into body fluids ;Timepoint(s) of evaluation of this end point: 1, 4, 8, 12, 18, 24 hours after start of echinocandin infusion or single time within this period | — |
Countries
Austria
Contacts
Medizinische Universität Innsbruck, Universitätsklinik für Innere Medizin I