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

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Patient receives an allogeneic haematopoietic stem cell transplant following myeloablative chemotherapy or receives intensive chemotherapy for AML-MDS
2. Subject is at least 18 and not older than 65 years of age on the day of the first dosing.
3. Has no signs or symptoms of invasive fungal disease
4. If a woman, is neither pregnant nor able to become pregnant and is not nursing an infant
5. Has an ALAT, ALAT, alkaline phosphatase < 5 times the upper limit of normal and a bilirubin level < 3 times the upper limit of normal
6. Is not known to be hypersensitive to echinocandin antifungal agents
7. Is managed with a quadruple central venous catheter (Arrow-Howes™ Quad-Lumen 8.5,5 French; Arrow International)
8. Subject is able and willing to sign the Informed Consent before screening evaluations.
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Documented history of sensitivity to medicinal products or excipients similar to those found in the anidulafungin preparation
2. Known of positive HIV test or hepatitis B or C test in history.
3. History of QT time prolongation.
4. History of or current abuse of drugs, alcohol or solvents.
5. Inability to understand the nature of the trial and the procedures required.
6. Has not previously participated in this trial

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the pharmacokinetics of anidulafungin given once in every 2 days (q48h) or once in every 3 days (q72h) to patients undergoing an allogeneic haematopoietic stem cell transplant following myeloablative chemotherapy or receiving intensive chemotherapy for AML-MDS<br><br><br>;Primary end point(s): Geometric Mean Ratio (GMR) of the area under the concentration time curve (AUC) of anidulafungin: comparison between both treatment regimens after 600mg and after the last dose.<br>;Secondary Objective: To determine whether adequate exposure is attained by patients undergoing an allogeneic haematopoietic stem cell transplant following myeloablative chemotherapy or receiving intensive chemotherapy for AML-MDS when using a q48 hour or a q72 hour dosing regimen<br><br>To determine whether infusion time can be advanced to 2 mg/min (both regimens) <br><br>To determine the safety of anidulafungin in this patient population<br>

Secondary Outcome Measures

Name	Time	Method

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