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Concentrations of antifungals of the echinocandin group various body fluids – a pilot study

Concentrations of echinocandins in ascites, pleural effusion, bile, wound secretion and cerebrospinal fluid – a pilot study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2013-005065-38-AT
Enrollment
126
Registered
2013-12-16
Start date
2014-02-17
Completion date
Unknown
Last updated
2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Invasive fungal infection treated with an echinocandin and indication for paracentesis, thoracentesis, bile deviation or sampling, lumbar puncture or VAC therapy

Interventions

Trade Name: Cancidas Product Name: Cancidas Pharmaceutical Form: Concentrate and solvent for concentrate for solution for infusion INN or Proposed INN: CASPOFUNGIN CAS Number: 162808-62-0 Concentratio

Sponsors

Medizinische Universität Innsbruck, Universitätsklinik für Innere Medizin I
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime 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

MeasureTime 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

Public ContactIntensivstation

Medizinische Universität Innsbruck, Universitätsklinik für Innere Medizin I

romuald.bellmann@i-med.ac.at4351250424181

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 14, 2026