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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
Scientific title
Performance of Emerging Microbiological Techniques for the Diagnosis of Severe Infections in Neutropenic Patients With Haematological Malignancies
Secondary ID [1] 0 0
HREC/2021/QRBW/78988
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Febrile Neutropenia 0 0
Condition category
Condition code
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Sensitivity and specificity of T2MR as compared to Blood Cultures for the diagnosis of proven, probable, and possible BSI as previously defined
Timepoint [1] 0 0
01/04/2022 - 31/03/2023
Secondary outcome [1] 0 0
In patients with positive T2 results: Mean time to result of T2MR
Timepoint [1] 0 0
01/04/2022 - 31/03/2023
Secondary outcome [2] 0 0
In patients with positive T2 results: percentage of potential antimicrobial modifications according to T2 results
Timepoint [2] 0 0
01/04/2022 - 31/03/2023

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients not able to provide informed consent
* Death is deemed imminent

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/01/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2023
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Royal Brisbane Hospital - Brisbane
Recruitment postcode(s) [1] 0 0
4170 - Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT05174546
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05174546