Respiratory Tract InfectionsRAISENCT03299608
Rapid Analysis of Infections by Spectrometry of Exhaled Breath
An observational study of Respiratory Tract Infections and Hematologic Diseases, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
To quantify the diagnostic, prognostic and therapeutic value of spectrometric analysis of exhaled breath from hematological patients with respiratory infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Tract Infections, Hematologic Diseases
- What is being tested?
- Breath analysis
- How many people
- 246 participants
- Where
- 1 siteBelgium
- Study dates
- 21 Jun 2019to Sep 2025
- 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 at high risk for opportunistic respiratory infections due to acute myeloid or lymphatic leukemia (undergoing intensive treatment), patients who underwent allogeneic stem cell transplantation, and patients receiving autologous stem cell transplantation
Who may be able to join
- Age ≥ 18y at start of study
- One of the following diagnoses:
- De novo, refractory or relapsed AML/MDS receiving intensive chemotherapy
- De novo, refractory or relapsed ALL/T-lymphoblastic lymphoma receiving intensive chemotherapy
- Aplastic anemia requiring ATG therapy
- Any patient admitted for either autologous hematopoietic stem cell transplantation. Transplantation may not have been performed at time of enrolment.
- Any patient admitted with allogeneic hematopoietic stem cell transplantation within the last year, or planned during this admission.
- Written informed consent obtained from the patient
Who cannot join
- Hematological disease beyond the specified inclusion criteria
- Signs of active respiratory infection
- If previously enrolled: incomplete clearance of all signs of respiratory infection (both clinically, microbiologically and radiologically).
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals Leuven
Leuven, 3000
Toine Mercier, MD, +32 16 34 00 04, toine.mercier@uzleuven.be
About this study
Official title: Exhaled Breath Analysis for Rapid Diagnosis in Opportunistic Respiratory Infections in Hematological Patients
To quantify the diagnostic, prognostic and therapeutic value of spectrometric analysis of exhaled breath from hematological patients with respiratory infection.
- Conditions
- Respiratory Tract Infections, Hematologic Diseases
- Being tested
- Breath analysis
- Medical subject headings
- Respiratory Tract Infections, Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath analysisDiagnostic test
Spectrometric analysis of exhaled breath as screening for opportunistic respiratory infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy
Accuracy (expressed as specificity/sensitivity/NPV/PPV) will be assessed as compared to the revised EORTC-MSG criteria, at moment of diagnosis by high-resolution CT and bronchoscopy
Measured: Through study completion (i.e. 6 weeks after diagnosis)
Secondary outcomes (2)
Diagnostic accuracy at 2 weeks as compared to the revised EORTC-MSG response criteria using high-resolution CT
Measured: 2 weeks after diagnosis
Diagnostic accuracy at 2 weeks as compared to the revised EORTC-MSG response criteria using high-resolution CT
Measured: 6 weeks after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start21 Jun 2019
- Primary completionJun 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 246 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299608
- Sponsor's protocol ID
- S60785
- Acronym
- RAISE
- Status last verified
- Jul 2024
- First submitted
- 15 Sep 2017
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exhaled Breath Analysis for Rapid Diagnosis in Opportunistic Respiratory Infections in Hematological Patients
- ClinicalTrials.gov ID
- NCT03299608
- Acronym / sponsor ID
- RAISE / S60785
- Conditions
- Respiratory Tract Infections, Hematologic Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 21 Jun 2019 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 3 Oct 2017 (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.
To quantify the diagnostic, prognostic and therapeutic value of spectrometric analysis of exhaled breath from hematological patients with respiratory infection.
Study design
- Observational model
- Cohort
- 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 at high risk for opportunistic respiratory infections due to acute myeloid or lymphatic leukemia (undergoing intensive treatment), patients who underwent allogeneic stem cell transplantation, and patients receiving autologous stem cell transplantation
Key inclusion criteria (8 listed)
- Age ≥ 18y at start of study
- One of the following diagnoses:
- Written informed consent obtained from the patient
Key exclusion criteria (3 listed)
- Hematological disease beyond the specified inclusion criteria
- Signs of active respiratory infection
- If previously enrolled: incomplete clearance of all signs of respiratory infection (both clinically, microbiologically and radiologically).
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 |
|---|---|---|
| Breath analysisSpectrometric analysis of exhaled breath as screening for opportunistic respiratory infections | Diagnostic test | – |
Primary outcome
Diagnostic accuracy
Time frame: Through study completion (i.e. 6 weeks after diagnosis)
Accuracy (expressed as specificity/sensitivity/NPV/PPV) will be assessed as compared to the revised EORTC-MSG criteria, at moment of diagnosis by high-resolution CT and bronchoscopy
2 secondary outcomes
Diagnostic accuracy at 2 weeks as compared to the revised EORTC-MSG response criteria using high-resolution CT
Time frame: 2 weeks after diagnosis
Diagnostic accuracy at 2 weeks as compared to the revised EORTC-MSG response criteria using high-resolution CT
Time frame: 6 weeks after diagnosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
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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 Respiratory Tract Infections and Hematologic Diseases, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 8 inclusion and 3 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 3 Jul 2024. 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 Belgium. 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?
Contact Toine Mercier, MD (+32 16 34 00 04, toine.mercier@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy (time frame: Through study completion (i.e. 6 weeks after diagnosis)). 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 3 Jul 2024.