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

• Conditions: Invasive fungal infection treated with an echinocandin and indication for paracentesis, thoracentesis, bile deviation or sampling, lumbar puncture or VAC therapy; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2013-005065-38-AT
• Lead Sponsor: Medizinische Universität Innsbruck, Universitätsklinik für Innere Medizin I

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-16
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 126

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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified