Rapid Analysis of Infections by Spectrometry of Exhaled Breath

Universitaire Ziekenhuizen KU Leuven246 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

246

Conditions

Respiratory Tract Infections Hematologic Diseases

Interventions

Breath analysisDIAGNOSTIC_TEST

Spectrometric analysis of exhaled breath as screening for opportunistic respiratory infections

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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: * 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).

Locations (1)

University Hospitals Leuven

Leuven, Belgium

RECRUITING

Outcomes

Primary Outcomes

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

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

Central Contacts

Toine Mercier, MD

CONTACT

+32 16 34 00 04 toine.mercier@uzleuven.be

Data from ClinicalTrials.gov

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