Overview
Anidulafungin in Patients With Hematologic Malignancies
Status:
Terminated
Terminated
Trial end date:
2011-09-01
2011-09-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
Study objectives To evaluate the safety of the echinocandin anidulafungin for prophylaxis or treatment of invasive fungal infections (IFI) in hematologic patients. Study design, Study conduct period Prospective, open label, phase II, one arm, single centre study October 2009 - September 2010 Study population Twenty adult patients (≥ 18 years) with a hematologic disorder and an indication for antifungal prophylaxis or therapy, but a relative contraindication for azoles or polyenes due to hepatic and renal dysfunction respectively Methods and Main Out-come Variables Main Outcome Parameter Safety: Adverse events and changes of important laboratory parameters with clinical impact will be reported. Secondary Outcome Parameter Efficacy: In therapeutically use the outcome will be categorized into success or failure. For patients receiving anidulafungin as prophylaxis the number and rate of breakthrough infections will be documented. Risk assessment Treatment related adverse effects as reported in the approved physician prescribing information (usually mild and with an incidence of < 5%). Treatment failure due to resistant pathogens. Expected benefit from this study IFI is a major cause of death among hematological patients, especially those undergoing high dose chemotherapy. It is conceivable that anidulafungin is a new treatment option for patients in whom azoles or polyenes are relatively contraindicated.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Elisabethinen HospitalCollaborator:
PfizerTreatments:
Anidulafungin
Echinocandins
Criteria
Inclusion Criteria:- Adult patients (≥ 18 years) with a hematologic disorder AND an indication for IFI
prophylaxis or therapy, but a relative contraindication for azoles or polyenes due to
hepatic or renal dysfunction*, are scheduled to receive anidulafungin for one of the
following specific indications:
- Need for primary antifungal prophylaxis in patients with Acute leucaemia/MDS during
induction, reinduction or consolidation chemotherapy (who are expected to become
neutropenic for at least 10 days) OR after allogenic HSCT with GvHD (at least grade II
or more - systemic steroid treatment required)
- Need for secondary antifungal prophylaxis in patients with the history of a proven or
probable invasive fungal infection who are expected to become neutropenic during
induction, reinduction or consolidation chemotherapy
- Indication for treatment of proven**, probable or possible fungal infection:
- Neutropenic patients with fever resistant to antibiotics (empirical use)
- Neutropenic patients with fever resistant to antibiotics and additive laboratory
or imaging signs of IFI (preemptive use)
- Patients who failed other antifungal therapy due to intolerance or progressive
infection
Exclusion Criteria:
- Absence of written informed consent
- Female patients who are pregnant or lactating
- Use of anidulafungin within 30 days prior to study
- Known hypersensitivity to anidulafungin
- Proven IFI with pathogen of known resistance to echinocandins (e.g. zygomycetes)
- Life expectancy less than 1 month
- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results and, in the judgment of the investigator, would make the subject
inappropriate for entry into this study.