Prospective, Open-label, Comparative, Multicenter Study of Voriconazole Compared to Itraconazole for the Primary Prophylaxis of Invasive Fungal Infections (IFI) in Subjects with Allogeneic Hematopoietic Stem Cell Transplants (HSCT)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 500

Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
·Males or females = 12 years of age.
·Subjects who will be receiving allogeneic HSCT for acute leukemia (AML, ALL or myelodysplastic syndrome) failure of therapy for lymphoma or transformation of chronic myeloid leukemia
·Signed and dated informed consent will be obtained from each subject in accordance with the local regulatory and legal requirements
·Females of childbearing potential must have a negative serum b-HCG pregnancy test and use an approved method of contraception throughout the study
Are the trial subjects under 18? yes
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects presenting with any of the following must not be included in the trial:
·Probable or proven IFI at study entry or at any time in 6 months prior to study entry, defined according to the consensus criteria” (Ascioglu et al 2002 ).
·Any previous history of zygomycosis (e.g. Mucor, Absidia, Rhizopus).
·Use of any systemically active antifungal agent within the 7 days prior to study entry.
·Allergy to study drugs or any excipients.
·Abnormal laboratory test results, defined as impaired hepatic function, as shown by transaminases or alkaline phosphatase, > 5 x Upper Limit of Normal [ULN], bilirubin >2.5mg/dL.
·Severe disease other than underlying condition, likely to jeopardize the planned termination of the study (e.g. acute myocardial infarction, unstable angina pectoris, potentially pro-arrhythmic conditions such as cardiac impairment due to previous cardiotoxic chemotherapy, previous torsade de pointes, prolongation of the QT interval > 450 msec for men or > 470 msec for women).
·Concomitant use of sirolimus, ergot alkaloids, terfenadine, astemizole, cisapride, pimozide, quinidine, carbamazepine, rifampicin, phenobarbital, ritonavir or efavirenz which might interfere with the evaluation of study drugs during the study.
·Alcohol and/or any other drug abuse.
·Previous participation in this trial.
·Unable and/or unlikely to comprehend and/or follow the protocol.
·Participation in any other studies involving investigational products, concomitantly or within 30 days prior to entry in the study.
·Anticipated survival less than one month.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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