Status:
COMPLETED
Pharmacokinetics of Anidulafungin (Ecalta ®) Intravenous Given to Patients at High Risk for Developing Invasive Fungal Disease
Lead Sponsor:
Radboud University Medical Center
Conditions:
Leukemia
Myelodysplastic Syndrome
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to study the pharmacokinetics of anidulafungin (Ecalta ®) given intravenously as antifungal prophylaxis to recipients of an allogeneic haematopoietic stem cell transplant ...
Detailed Description
Alternate dosing strategies of echinocandin drugs might provide a better efficacy in the treatment of fungal infections as compared to the current label dosing strategy. Before conducting a controlled...
Eligibility Criteria
Inclusion
- Patient receives an allogeneic haematopoietic stem cell transplant following myeloablative chemotherapy or receives intensive chemotherapy for AML-MDS
- Subject is at least 18 and not older than 65 years of age on the day of the first dosing
- Has no signs or symptoms of invasive fungal disease
- If a woman, is neither pregnant nor able to become pregnant and is not nursing an infant
- Has an ALAT, ALAT, alkaline phosphatase \< 5 times the upper limit of normal and a bilirubin level \< 3 times the upper limit of normal
- Is not known to be hypersensitive to echinocandin antifungal agents
- Is managed with a quadruple central venous catheter (Arrow-Howes™ Quad-Lumen 8.5,5 French; Arrow International)
- Subject is able and willing to sign the Informed Consent before screening evaluations
Exclusion
- Documented history of sensitivity to medicinal products or excipients similar to those found in the anidulafungin preparation
- Known of Positive HIV test or hepatitis B or C test in history
- History of QT time prolongation
- History of or current abuse of drugs, alcohol or solvents
- Inability to understand the nature of the trial and the procedures required
- Has not previously participated in this trial
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01249820
Start Date
November 1 2010
End Date
January 1 2013
Last Update
December 8 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands