Febrile NeutropeniaNCT05174546
New Diagnostics in Neutropenia
An observational study of Febrile Neutropenia, run by The University of Queensland at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Febrile Neutropenia
- What is being tested?
- T2 magnetic resonance
- How many people
- 100 participants
- Where
- 1 siteAustralia
- Study dates
- 10 Jan 2023to Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients not able to provide informed consent
- Death is deemed imminent
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Royal Brisbane Hospital
Brisbane, Queensland, 4170
Andrea Henden, MD, Andrea.Henden@health.qld.gov.au
About this study
Official title: Performance of Emerging Microbiological Techniques for the Diagnosis of Severe Infections in Neutropenic Patients With Haematological Malignancies
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.
Read the detailed description
Study Background
In patients with haematological malignancies, neutropenia often leads to the development of severe infections, including bloodstream, which are characterized by high mortality. Patients' management can be challenging as conventional diagnostic methods for the diagnosis of such infections are affected by several limitations, including limited sensitivity and long turnaround time.
T2 Magnetic Resonance (T2MR) is a new technology able to identify pathogens directly from whole blood in few hours, and preliminary data showed how it might have higher sensitivity compared to blood cultures.
Study Aims
- To assess the performance of the T2MR (including the T2Candida, T2Bacteria and T2Resistance) in diagnosing proven, probable, and possible bloodstream infection (BSI) due to T2 on-panel pathogens, in patients affected by haematological malignancies with febrile neutropenia, including patients with acute leukaemia and bone marrow transplant recipients.
- To assess the mean time to results of the T2MR 3 panels as compared to blood cultures. These will be considered as an estimate of time to optimal treatment in proven, probable, and possible BSI.
- To estimate the potential impact of T2MR results on antimicrobial modifications in neutropenic patients with proven/probable and possible BSI.
Methods
Prospective observational study. Patients with acute leukemia or bone marrow transplant recipients and febrile neutropenia, admitted to the Haematology ward, will be consecutively enrolled in the study. 100 consecutive febrile episodes will be included in the study.
At the time of blood culture collection (ordered as per standard of care), blood samples for T2MR (including T2Bacteria, T2Candida and T2Resistance) will be also collected.
The performance of the T2 assays will be compared to that of proven, probable, and possible BSI defined by standard of care laboratory practices due to T2 on-panel pathogens, and time to results will be assessed as an estimate of time to optimal treatment.
Moreover the potential impact of T2 positive results on antimicrobial modifications will be estimated including escalation, de-escalation and antimicrobial change.
Proven BSI is defined by a positive blood culture; probable BSI is defined by a negative blood culture but a positive T2 result if the T2-detected organism is isolated within 21 days from another clinical specimen; possible BSI is defined as a negative blood culture but a positive T2 result in the absence of supporting culture data if the T2-detected organism or resistance gene was a plausible cause of infection.
Data analysis
Sensitivity, specificity, and predictive values will be calculated using proven, probable, and possible BSI as a reference, with 95% confidence intervals.
Mean time to T2 results will be compared to mean time to blood cultures results.
- Conditions
- Febrile Neutropenia
- Being tested
- T2 magnetic resonance
- Medical subject headings
- Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T2 magnetic resonanceDiagnostic 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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 01/04/2022 - 31/03/2023
Secondary outcomes (2)
In patients with positive T2 results: Mean time to result of T2MR
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.
Measured: 01/04/2022 - 31/03/2023
In patients with positive T2 results: percentage of potential antimicrobial modifications according to T2 results
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)
Measured: 01/04/2022 - 31/03/2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study start10 Jan 2023
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Febrile NeutropeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Queensland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174546
- Sponsor's protocol ID
- HREC/2021/QRBW/78988
- Status last verified
- May 2023
- First submitted
- 13 Dec 2021
- Last updated
- 22 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Emerging Microbiological Techniques for the Diagnosis of Severe Infections in Neutropenic Patients With Haematological Malignancies
- ClinicalTrials.gov ID
- NCT05174546
- Acronym / sponsor ID
- HREC/2021/QRBW/78988
- Conditions
- Febrile Neutropenia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The University of QueenslandUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 30 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Background
In patients with haematological malignancies, neutropenia often leads to the development of severe infections, including bloodstream, which are characterized by high mortality. Patients' management can be challenging as conventional diagnostic methods for the diagnosis of such infections are affected by several limitations, including limited sensitivity and long turnaround time.
T2 Magnetic Resonance (T2MR) is a new technology able to identify pathogens directly from whole blood in few hours, and preliminary data showed how it might have higher sensitivity compared to blood cultures.
Study Aims
- To assess the performance of the T2MR (including the T2Candida, T2Bacteria and T2Resistance) in diagnosing proven, probable, and possible bloodstream infection (BSI) due to T2 on-panel pathogens, in patients affected by haematological malignancies with febrile neutropenia, including patients with acute leukaemia and bone marrow transplant recipients.
- To assess the mean time to results of the T2MR 3 panels as compared to blood cultures. These will be considered as an estimate of time to optimal treatment in proven, probable, and possible BSI.
- To estimate the potential impact of T2MR results on antimicrobial modifications in neutropenic patients with proven/probable and possible BSI.
Methods
Prospective observational study. Patients with acute leukemia or bone marrow transplant recipients and febrile neutropenia, admitted to the Haematology ward, will be consecutively enrolled in the study. 100 consecutive febrile episodes will be included in the study.
At the time of blood culture collection (ordered as per standard of care), blood samples for T2MR (including T2Bacteria, T2Candida and T2Resistance) will be also collected.
The performance of the T2 assays will be compared to that of proven, probable, and possible BSI defined by standard of care laboratory practices due to T2 on-panel pathogens, and time to results will be assessed as an estimate of time to optimal treatment.
Moreover the potential impact of T2 positive results on antimicrobial modifications will be estimated including escalation, de-escalation and antimicrobial change.
Proven BSI is defined by a positive blood culture; probable BSI is defined by a negative blood culture but a positive T2 result if the T2-detected organism is isolated within 21 days from another clinical specimen; possible BSI is defined as a negative blood culture but a positive T2 result in the absence of supporting culture data if the T2-detected organism or resistance gene was a plausible cause of infection.
Data analysis
Sensitivity, specificity, and predictive values will be calculated using proven, probable, and possible BSI as a reference, with 95% confidence intervals.
Mean time to T2 results will be compared to mean time to blood cultures results.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
- an ANC of <500 cells/mm3
- a single temperature measurement of ≥38.0°C
Key exclusion criteria (2 listed)
- Patients not able to provide informed consent
- Death is deemed imminent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T2 magnetic resonanceSamples 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 | Diagnostic test | – |
Primary outcome
Sensitivity and specificity of T2MR as compared to Blood Cultures for the diagnosis of proven, probable, and possible BSI as previously defined
Time frame: 01/04/2022 - 31/03/2023
Sensitivity and specificity of T2 magnetic resonance will be calculated with 95% confidence intervals both for pathogen identification and resistance markers detection
2 secondary outcomes
In patients with positive T2 results: Mean time to result of T2MR
Time frame: 01/04/2022 - 31/03/2023
In patients with positive T2 results: percentage of potential antimicrobial modifications according to T2 results
Time frame: 01/04/2022 - 31/03/2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
Related trials for Febrile Neutropenia
Not yet recruiting
Diagnostic Accuracy, Clinical Utility and Implementation of Point-of-Care Absolute Neutrophil Count in Suspected Neutropenic Fever (DUCATIS) - Diagnostic Accuracy (S1)
Suspected Neutropenic Fever, Confirmed Neutropenic Fever
RecruitingObservational study
Mecapegfilgrastim for Prevention of Chemotherapy-Induced Neutropenia in Advanced Breast Cancer
Breast Cancer, Chemotherapy-induced Neutropenia
Not yet recruiting
Impact of a Telemonitoring Device on the Occurever at Home in Children at Risk of Chemotherapy-Induced Neutropenia
Oncopediatrics, Febrile Neutropenia
Recruiting
Swiss 2024 Continous Fever Monitoring in Pediatric Oncology Patients
Pediatric Oncology Patients With Risk for Infections
Not yet recruitingPhase 2
Restrictive Versus Standard Antibiotic Treatment During CAR-T Therapy
Large B-Cell Lymphoma (LBCL), Multiple Myeloma (MM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Febrile Neutropenia, run by The University of Queensland at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of T2MR as compared to Blood Cultures for the diagnosis of proven, probable, and possible BSI as previously defined (time frame: 01/04/2022 - 31/03/2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2023.