Rapid Analysis of Infections by Spectrometry of Exhaled Breath

Respiratory Tract Infections Clinical Trial

— RAISE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03299608
• Other study ID #: S60785
• Status: Recruiting
• Start date: June 21, 2019
• Est. completion date: September 2021

Study information

• Verified date: June 2019
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Toine Mercier, MD
• Phone: +32 16 34 00 04
• Email: toine.mercier[@]uzleuven.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 246
• Est. completion date: September 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Communicable Diseases
• Hematologic Diseases
• Infection
• Respiratory Tract Infections

Intervention

Diagnostic Test:
• Breath analysis
Spectrometric analysis of exhaled breath as screening for opportunistic respiratory infections

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Through study completion (i.e. 6 weeks after diagnosis)
Secondary	Diagnostic accuracy at 2 weeks as compared to the revised EORTC-MSG response criteria using high-resolution CT		2 weeks after diagnosis
Secondary	Diagnostic accuracy at 2 weeks as compared to the revised EORTC-MSG response criteria using high-resolution CT		6 weeks after diagnosis