New Diagnostics in Neutropenia

NCT05174546 | Unknown

• 1 other identifier: HREC/2021/QRBW/78988
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Febrile Neutropenia

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of T2MR as compared to Blood Cultures for the diagnosis of proven, probable, and possible BSI as previously defined

  Sensitivity and specificity of T2 magnetic resonance will be calculated with 95% confidence intervals both for pathogen identification and resistance markers detection

  01/04/2022 - 31/03/2023

Secondary Outcomes (2)

• In patients with positive T2 results: Mean time to result of T2MR

  01/04/2022 - 31/03/2023

• In patients with positive T2 results: percentage of potential antimicrobial modifications according to T2 results

  01/04/2022 - 31/03/2023

Interventions

T2 magnetic resonance DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients affected by acute leukemia and bone marrow transplant recipients who are admitted to the Haematology Unit and are expected to encounter chemotherapy-induced or pre/post-transplant neutropenia during the course of hospital admission, will be approached by research staff to discuss participation. Study aims and design will be discussed and the opportunity to read the Patient Information and Consent Form and ask questions will be provided. Patients or their representative will be provided an informed consent form to confirm participation, and consent will be obtained prior to episodes of febrile neutropenia. In consenting patients, in the subsequent case of febrile episodes during neutropenia, the collection of blood samples for T2MR assessment will be performed in addition to blood cultures ordered as per standard of care.

You may qualify if:

• 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

You may not qualify if:

• Patients not able to provide informed consent
• Death is deemed imminent

Sponsors & Collaborators

• The University of Queensland: lead

Study Sites (1)

Royal Brisbane Hospital

Brisbane, Queensland, 4170, Australia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Febrile Neutropenia

Interventions

Magnetic Resonance Myelography

Condition Hierarchy (Ancestors)

Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Intervention Hierarchy (Ancestors)

Myelography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Magnetic Resonance Imaging; Tomography; Diagnostic Techniques, Neurological; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: December 30, 2021
• Study Start: January 10, 2023
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: May 22, 2023

Record last verified: 2023-05

Locations

AU (1)