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RecruitingNCT03299608RAISEUpdated Jul 3, 2024

Rapid Analysis of Infections by Spectrometry of Exhaled Breath

An observational study in Respiratory Tract Infections and Hematologic Diseases, sponsored by Universitaire Ziekenhuizen KU Leuven. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-03.

Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
246
Ages
18 Years and older
Sex
All
01

Study summary

To quantify the diagnostic, prognostic and therapeutic value of spectrometric analysis of exhaled breath from hematological patients with respiratory infection.

02

Conditions studied

  • Respiratory Tract Infections
  • Hematologic Diseases
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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).
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
246 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testBreath analysis

    Spectrometric analysis of exhaled breath as screening for opportunistic respiratory infections

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: Through study completion (i.e. 6 weeks after diagnosis)

Secondary outcomes

  1. Diagnostic accuracy at 2 weeks as compared to the revised EORTC-MSG response criteria using high-resolution CT

    Time frame: 2 weeks after diagnosis

  2. Diagnostic accuracy at 2 weeks as compared to the revised EORTC-MSG response criteria using high-resolution CT

    Time frame: 6 weeks after diagnosis

06

Study locations

1 of 1 sites recruiting
  • University Hospitals Leuven
    Leuven, 3000, Belgium
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03299608
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Responsible party
Sponsor
First posted
Oct 3, 2017
Start date
Jun 21, 2019
Primary completion
Jun 2025 (estimated)
Completion
Sep 2025 (estimated)
Last update
Jul 3, 2024

Study contacts

Toine Mercier, MD
Contact
toine.mercier@uzleuven.be
+32 16 34 00 04

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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