Prospective, Open-label, Non-comparative, Multicenter Study for the Secondary Prophylaxis of Invasive Fungal Infections (IFI) with Voriconazole in Patients with Allogeneic Stem Cell Transplants

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 75

Inclusion Criteria

Male and female patients with the diagonosis of acute leukemia or acute transformation of chronic myeloic leukemia and with allogenic stem cell transplantation (myeloablative or non-myeloablative regimen), planned in the next 3 weeks and previous proven or probable IFI in the last 6 months, defined according to the MSG/EORTC diagnostic criteria (Ascioglu et al., CID 2002) at the time of the initial diagnosis of IFI, and with no signs or symptoms of active disease.

Signed and dated informed consent will be obtained

Females of childbearing potential must have a negative serum B-HCG pregnancy test and be practicing an effective form of contraception

Age >= 18 years
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pregnant or lactating women, or women of childbearing potential not
using an acceptable method of contraception

Severe disease other than underlying condition, likely to jeopardize the
planned termination of the study (e.g. acute myocardial infarction,
unstable angina pectoris)

Abnormal baseline findings considered by the investigator to be
indicative of conditions that might affect study results (e.g. short bowel
syndrome)

Previous history of zygomycosis (eg Mucor, Absidia, Rhizopus)

Positive serum galactomannan antigen test (level 1.5)

Active, symptomatic, uncontrolled IFI (persistence of clinical
symptoms related to active fungal disease)

Any biological fungal criterion of active fungal disease as defined by
the MSG-EORTC criteria, i.e. persistence of positive microbiological
blood cultures or Aspergillus antigenemia, at time of randomization
(Appendix E)

Patients with candiduria

Previous failure of voriconazole in the treatment of IFI

Known intolerance to azole compounds

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 specific systemic diseases

Other medical conditions, including HIV-positive serology, that would
interfere with the evaluation of the therapeutic response or safety of the
study drug

Alcohol and/or any other drug abuse

Previous participation in this trial

Abnormal laboratory test results, defined as impaired hepatic function,
as shown by but not limited to (transaminases, alkaline phosphatases,
or bilirubin > 5 x Upper Limit of Normal [ULN])

Impaired renal function, as shown by but not limited to estimated
creatinine clearance (Clcr) < 50 mL/minute (as per Cockroft-Gault
formula (Appendix F)

Any other condition which, in the investigator's judgment, might
increase the risk to the subject or decrease the chance of obtaining
satisfactory data to achieve the objectives of the study

Mental condition rendering the subject unable to understand the nature,
scope and possible consequences of the study and/or evidence of an
uncooperative attitude

Unable and/or unlikely to comprehend and/or follow the protocol

Participation in any other studies involving investigational or marketed
products, concomitantly or within 30 days prior to entry in the study

Anticipated survival less than 72 hours

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

Related Trials