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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05174546
Registration number
NCT05174546
Ethics application status
Date submitted
13/12/2021
Date registered
30/12/2021
Date last updated
22/05/2023
Titles & IDs
Public title
New Diagnostics in Neutropenia
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Scientific title
Performance of Emerging Microbiological Techniques for the Diagnosis of Severe Infections in Neutropenic Patients With Haematological Malignancies
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Secondary ID [1]
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HREC/2021/QRBW/78988
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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:
Febrile Neutropenia
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Condition category
Condition code
Blood
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Other blood disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Diagnosis / Prognosis - T2 magnetic resonance
Diagnosis / Prognosis: T2 magnetic resonance
Samples for assessment by the T2MR will be collected once daily in occasion of any consecutive febrile episode during neutropenia when blood cultures are ordered as per standard of care. T2 magnetic resonance will be run according to manufacturer's instructions
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Intervention code [1]
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Diagnosis / Prognosis
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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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Sensitivity and specificity of T2MR as compared to Blood Cultures for the diagnosis of proven, probable, and possible BSI as previously defined
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Assessment method [1]
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Sensitivity and specificity of T2 magnetic resonance will be calculated with 95% confidence intervals both for pathogen identification and resistance markers detection
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Timepoint [1]
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01/04/2022 - 31/03/2023
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Secondary outcome [1]
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In patients with positive T2 results: Mean time to result of T2MR
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Assessment method [1]
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In patients with positive T2 results, the theoretical mean time to T2 results (if T2 assessment had been performed real time as part of the clinical laboratory workflow) will be assessed.
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Timepoint [1]
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01/04/2022 - 31/03/2023
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Secondary outcome [2]
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In patients with positive T2 results: percentage of potential antimicrobial modifications according to T2 results
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Assessment method [2]
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In the case of positive T2 results, the impact of T2 results on potential antimicrobial treatment modification will be assessed. Specifically, the percentage of cases where an early T2 result would be useful for antimicrobial modification out of all the febrile episodes will be evaluated. Antimicrobial treatment changes considered will be:
* De-escalation of treatment (replacing current treatment with an antimicrobial with narrower spectrum)
* Escalation of treatment (replacing current treatment with an antimicrobial with broader spectrum)
* Change of antimicrobials (replacing current treatment with an antimicrobial with similar spectrum, i.e. from vancomycin to daptomycin in case of detection of van gene)
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Timepoint [2]
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01/04/2022 - 31/03/2023
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Eligibility
Key inclusion criteria
Adult patients (> 18 years old) affected by acute leukaemia and/or recipients of bone marrow transplantation for any disease indication (during the pre and post-transplant phase) who develop febrile neutropenia, where blood cultures (and possibly bronchoscopy) are ordered as per standard of care.
Febrile neutropenia is defined as:
* an ANC of <500 cells/mm3
* a single temperature measurement of =38.0°C
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Minimum age
18
Years
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Maximum age
No limit
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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 not able to provide informed consent
* Death is deemed imminent
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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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
10/01/2023
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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
1/07/2023
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Royal Brisbane Hospital - Brisbane
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Recruitment postcode(s) [1]
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4170 - Brisbane
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Funding & Sponsors
Primary sponsor type
Other
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Name
The University of Queensland
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Mortality due to bloodstream infections in patients with neutropenia and haematological malignancies is high and optimal management is hampered by long turnaround times of conventional blood cultures. This is an observational study to assess the performance of T2 magnetic resonance, in diagnosing proven, probable and possible bloodstream infections as well as its theoretical impact on antimicrobial prescriptions in neutropenic patients with acute leukemia and bone marrow recipients.
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Trial website
https://clinicaltrials.gov/study/NCT05174546
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05174546
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