Rapid Analysis of Infections by Spectrometry of Exhaled Breath

Exhaled Breath Analysis for Rapid Diagnosis in Opportunistic Respiratory Infections in Hematological Patients

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03299608

Acronym

RAISE

Enrollment

246

Registered

2017-10-03

Start date

2019-06-21

Completion date

2025-09-30

Last updated

2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Tract Infections, Hematologic Diseases

Brief summary

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

Interventions

DIAGNOSTIC_TESTBreath analysis

Spectrometric analysis of exhaled breath as screening for opportunistic respiratory infections

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic accuracy	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

Secondary

Measure	Time frame
Diagnostic accuracy at 2 weeks as compared to the revised EORTC-MSG response criteria using high-resolution CT	2 weeks after diagnosis

Countries

Belgium

Contacts

Primary ContactToine Mercier, MD

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026