Status:
COMPLETED
A Multicentre Randomised Controlled Trial Comparing Two Strategies for the Diagnosis of Invasive Aspergillosis in High-risk Haematology Patients
Lead Sponsor:
Bayside Health
Collaborating Sponsors:
National Health and Medical Research Council, Australia
Conditions:
Invasive Aspergillosis
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
Aspergillus is a fungus found in soil, on farms and on construction sites. In those whose immune system is impaired it causes severe infection. The people who are particularly at high-risk of infectio...
Eligibility Criteria
Inclusion
- 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
- 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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Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00163722
Start Date
September 1 2005
End Date
August 1 2011
Last Update
February 20 2013
Active Locations (6)
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1
St. Vincent's Hospital
Sydney, New South Wales, Australia, 2010
2
Westmead Hospital
Sydney, New South Wales, Australia, 2145
3
Royal Adelaide Hospital
Adelaide, South Australia, Australia
4
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3002