A Multicentre Randomised Controlled Trial Comparing the Current Standard Diagnostic Strategy for Invasive Aspergillosis to the New Diagnostic Strategy for Invasive Aspergillosis in High-Risk Haematology Patients in Order to Determine Which Strategy Results in the Lower Rates of Use of Empiric Antifungal Therapy
18 Years
80 Years
Both
Invasive Aspergillosis
Trial Information
A Multicentre Randomised Controlled Trial Comparing the Current Standard Diagnostic Strategy for Invasive Aspergillosis to the New Diagnostic Strategy for Invasive Aspergillosis in High-Risk Haematology Patients in Order to Determine Which Strategy Results in the Lower Rates of Use of Empiric Antifungal Therapy
Inclusion Criteria:
Patients fulfilling all the following criteria will be eligible for enrolment 1. Aged
18-80 years 2. Undergoing allogeneic haematopoietic stem cell transplantation (HSCT) for
any reason OR Undergoing intensive combination chemotherapy for acute myeloid leukaemia
(AML) or acute lymphoblastic leukaemia (ALL) 3. Has given written informed consent.
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Exclusion Criteria:
Patients with any of the following will be ineligible for enrolment 1. Other
immunocompromised states (e.g. HIV infection, solid organ transplantation, autoimmune
conditions treated with immunosuppressants etc.) besides those outlined in the inclusion
criteria above 2. Currently enrolled in an antifungal treatment trial (not an antifungal
prophylaxis trial) 3. Past history of proven or probable IA (as per standardized
definitions) during a previous cycle of chemotherapy 4. Currently have active IA or other
active invasive fungal infection 5. Prior enrolment in this study
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Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
The proportion of patients treated with at least 1 course of empiric antifungal therapy as per protocol definition at 26 weeks following randomisation
Outcome Time Frame:
26 weeks of follow-up
Safety Issue:
No
Principal Investigator
Monica Slavin, MB BS FRACP
Investigator Role:
Principal Investigator
Investigator Affiliation:
Infectious Diseases Unit, Peter MacCallum Cancer Centre, St. Andrew's Place, East Melbourne, Victoria, Australia
Authority:
Australia: Department of Health and Ageing Therapeutic Goods Administration
Study ID:
55/05
NCT ID:
NCT00163722
Start Date:
September 2005
Completion Date:
August 2011
Related Keywords:
- Invasive Aspergillosis
- Aspergillosis
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