Pharmacokinetics of Anidulafungin (Ecalta ®) Intravenous Given to Patients at High Risk for Developing Invasive Fungal Disease

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

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 following myeloablative chemotherapy or patients receiving intensive chemotherapy for AML-MDS who are at high risk for developing invasive fungal disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University
• Treatments: Anidulafungin; Echinocandins

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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