Secondary Prophylaxis of Invasive Fungal Infections MedDRA version: 7.0 Level: PT Classification code 10049085
Conditions
Interventions
Trade Name: Vfend
Product Name: Voriconazole
Product Code: N/A
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: voriconazol
Concentration unit: mg milligram(s)
Concentration
Sponsors
Pfizer S.A
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of voriconazole as secondary prophylaxis on the rate of occurrence of proven and probable invasive fungal infection (IFI) in allogenic stem cell transplant patients having acute leukemia or acute transformation of chronic myeloid leukemia with previous proven or probable invasive fungal infection from the Day of Transplant until the 12 month Follow-up;Secondary Objective: To evaluate the efficacy of voriconazole as secondary prophylaxis on the rate of occurrence of proven and probable invasive fungal infection (IFI) from the Day of Transplant until the 6 months Follow-up. To evaluate the efficacy of voriconazole as secondary prophylaxis on the rate of occurrence of proven and probable invasive fungal infection (IFI) from the Day of Transplant until the End of Prophylaxis. To evaluate time to occurrence of proven/probable recurrent/new IFIs from the day of transplant in SCT. To evaluate number of proven/probable recurrent/new IFIs from the day of transplant in SCT. To evaluate the safety of voriconazole, including overall tolerability (number and type of adverse events) To evaluate the number of adverse event leading to discontinuation of the study drug. To evaluate the proportion of patients fungal-free (no fungal infection, no death) at 6 and 12 months after transplant ;Primary end point(s): The primary efficacy variable is the rate of occurrence of proven or probable invasive fungal infections (IFI) between transplant and the 12 months follow-up, defined according to Ascioglu et al. (CID, 2002) criteria | — |
Countries
Spain, United Kingdom
Outcome results
None listed