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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00163722
Registration number
NCT00163722
Ethics application status
Date submitted
11/09/2005
Date registered
14/09/2005
Date last updated
20/02/2013
Titles & IDs
Public title
A Multicentre Randomised Controlled Trial Comparing Two Strategies for the Diagnosis of Invasive Aspergillosis in High-risk Haematology Patients
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Scientific title
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
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Secondary ID [1]
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ALLG SC01
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Secondary ID [2]
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55/05
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Invasive Aspergillosis
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Condition category
Condition code
Infection
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Other infectious diseases
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Infection
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Studies of infection and infectious agents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Culture and histology
Other interventions - Aspergillus galactomannan and PCR
Active Comparator: Standard diagnostic strategy of culture and histology - The standard-diagnostic strategy was designed to be consistent with the 2002 guidelines for antimicrobial use in neutropenic patients with cancer. When an invasive fungal infection was suspected (e.g. persistent fevers) cultures of blood, urine, sputum (if available) and faeces (if clinically indicated), and HRCT scans of chest were performed. Bronchoscopy and biopsies were performed according to institutional protocols. Empiric antifungal therapy was recommended whilst undergoing these investigations and was continued, de-escalated to prophylaxis, or changed to treatment of invasive aspergillosis or other IFD according to test results.
Experimental: Aspergillus galactomannan and PCR directed - Results of once to twice weekly testing with Aspergillus galactomannan and PCR directed the timing of CT scan performance and whether antifungal therapy was given
Other interventions: Culture and histology
Other interventions: Aspergillus galactomannan and PCR
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The proportion of patients treated with at least 1 course of empiric antifungal therapy as per protocol definition at 26 weeks following randomisation
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Assessment method [1]
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Timepoint [1]
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26 weeks of follow-up
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Secondary outcome [1]
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Invasive Aspergillosis related mortality rates
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Assessment method [1]
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Timepoint [1]
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26 weeks of follow-up
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Secondary outcome [2]
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Other invasive fungal infection-related (IFI) mortality rates
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Assessment method [2]
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Timepoint [2]
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26 weeks of follow-up
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Secondary outcome [3]
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All-cause mortality rates
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Assessment method [3]
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Timepoint [3]
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26 weeks of follow-up
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Secondary outcome [4]
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Nephrotoxicity rates
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Assessment method [4]
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Timepoint [4]
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26 weeks of follow-up
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Secondary outcome [5]
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Hepatotoxicity rates
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Assessment method [5]
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Timepoint [5]
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26 weeks of follow-up
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Secondary outcome [6]
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Total number of courses of empiric antifungal therapy
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Assessment method [6]
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Timepoint [6]
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26 weeks of follow-up
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Secondary outcome [7]
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Cost data associated with treatment and complications.
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Assessment method [7]
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To include number of hospital admissions, hospital length of stay, total duration of antifungal therapy and number of invasive procedures to diagnose invasive aspergillosis
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Timepoint [7]
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26 weeks of follow-up
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Secondary outcome [8]
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Incidence of proven, probable and possible invasive aspergillosis
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Assessment method [8]
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Timepoint [8]
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26 weeks of follow-up
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Secondary outcome [9]
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Incidence of proven, probable and possible other invasive fungal disease besides invasive aspergillosis
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Assessment method [9]
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Timepoint [9]
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26 weeks of follow-up
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Eligibility
Key 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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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2011
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Sample size
Target
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Accrual to date
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Final
240
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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St. Vincent's Hospital - Sydney
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Recruitment hospital [2]
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Westmead Hospital - Sydney
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Recruitment hospital [3]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [4]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [5]
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Alfred Hospital - Melbourne
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Recruitment hospital [6]
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Royal Melbourne Hospital - Melbourne
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Recruitment postcode(s) [1]
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2010 - Sydney
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Recruitment postcode(s) [2]
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2145 - Sydney
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Recruitment postcode(s) [3]
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- Adelaide
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Recruitment postcode(s) [4]
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3002 - Melbourne
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Recruitment postcode(s) [5]
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3004 - Melbourne
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Recruitment postcode(s) [6]
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3052 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Bayside Health
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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National Health and Medical Research Council, Australia
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Address [1]
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Ethics approval
Ethics application status
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Summary
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 infection with Aspergillus (which is called Invasive Aspergillosis)are those
with acute leukaemia who are having chemotherapy and those post bone marrow transplantation.
Currently 15% of those at high-risk develop Invasive Aspergillosis and 60-90% of those with
Invasive Aspergillosis die.
The main reason for this high death rate is that our current diagnostic tests are not good at
detecting infection or often only detect the infection at advanced stages when treatment is
ineffective. Because of the limitations of current diagnostic tests the current practice is
to give empiric antifungal therapy (EAFT) early to treat suspected Invasive Aspergillosis.
However studies have demonstrated that this therapy has only resulted in a minor reduction in
the mortality rates and it also causes significant drug toxicity. It is a suboptimal
treatment modality.
New tests have recently been developed to diagnose Invasive Aspergillosis. These tests are
for the detection of an Aspergillus protein in blood and for the detection of Aspergillus DNA
in blood. Available data suggests that these new tests make an early diagnosis and seem to be
able to monitor responses to treatment. However no study has been reported to date which
demonstrates that the use of these tests can impact on important patient outcomes. This trial
is being performed to determine whether the use of the new diagnostic tests to guide
antifungal therapy will help improve treatment of Invasive Aspergillosis, reduce drug
toxicity and reduce the death rate in the high-risk patients as compared with the current
standard method of diagnosis and treatment with EAFT.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00163722
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Monica Slavin, MB BS FRACP
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Address
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Infectious Diseases Unit, Peter MacCallum Cancer Centre, St. Andrew's Place, East Melbourne, Victoria, Australia
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Fax
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Email
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Contact person for public queries
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00163722
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