Exposure to micafungin given twice/week compared to once/day.

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

1.Patient receives immunosuppressive therapy for acuteGvHD grade II-IV or reduced in-tensity conditioning regimens for allogeneic stem cell transplant, or patients receiving first remission induction chemotherapy for AML/MDS.
2.Subject is at least 18 of age on the day of providing informed consent.
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.Less than 1 week of immunosuppressive therapy for grade II-IV acute GvHD
6.Is managed with a central venous catheter (preferably a quadruple Ar-row-Howes™ Quad-Lumen 8.5,5 French; Arrow International)
7.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: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1.Documented history of sensitivity to medicinal products or excipients similar to those found in the micafungin preparation
2.History of or current abuse of drugs, alcohol or solvents.
3.Inability to understand the nature of the trial and the procedures re-quired.
4.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 micafungin 300 mg given twice weekly on Mondays and Thursdays in patients at risk for developing an invasive fungal disease (patients who are being treated for acute or chronic graft versus host disease; patients receiving reduced intensity conditioning for SCT; receiving first remission induction chemotherapy for AML/MDS) compared to the pharmacokinetics of micafungin 100 mg given daily to the same population.;<br> Secondary Objective: To determine whether adequate exposure of micafungin is attained and to perform Monte Carlo simulations to provide the scientific background for alternate dosing strategies in the prophylactic setting.<br> To determine the safety of micafungin in this patient population<br> ;Primary end point(s): Comparison of PK parameters (AUC, Cmax) after both treatment regimens.;Timepoint(s) of evaluation of this end point: Day 4 or 5 and Day 8

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): Monte Carlo simulations<br> testing of covariates influencing PK<br> adverse events during the study<br> ;<br> Timepoint(s) of evaluation of this end point: Monta Carlo simulations: PK curves on Day 4 or 5 and Day 8, trough concentrations every day.<br> Adverse events will be collected during the entire study period.<br>

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