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 2

Completed

Conditions: fungal infection
hematology patients
10017528

Registration Number: NL-OMON34306

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

1. Patient receives an allogeneic haematopoietic stem cell transplant following myeloablative chemotherapy or receives first remission induction treatmentintensive 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

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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine the pharmacokinetics of anidulafungin given once in every 2 days<br /><br>(q48h) or once in every 3 days (q72h) to patients undergoing an allogeneic<br /><br>haematopoietic stem cell transplant following myeloablative chemotherapy or<br /><br>receiving intensive chemotherapy for AML-MDS</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To determine whether adequate exposure is attained by patients undergoing an<br /><br>allogeneic haematopoietic stem cell transplant following myeloablative<br /><br>chemotherapy or receiving in-tensive chemotherapy for AML-MDS when using a q48<br /><br>hour or a q72 hour dosing regimen<br /><br><br /><br>To determine whether infusion time can be advanced to 2 mg/min (both regimens)<br /><br><br /><br>To determine the safety of anidulafungin in this patient population</p><br>