Rapid Analysis of Infections by Spectrometry of Exhaled Breath

Recruiting

• Conditions: Hematologic Diseases; Respiratory Tract Infections

• Registration Number: NCT03299608
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-15
• Study First Submitted QC: 2017-09-27
• Study First Posted: 2017-10-03
• Study Start: 2019-06-21
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03
• Primary Completion: 2025-06
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 246

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Diagnostic accuracy at 2 weeks as compared to the revised EORTC-MSG response criteria using high-resolution CT	6 weeks after diagnosis

Trial Locations

Locations (1)

University Hospitals Leuven; 🇧🇪 Leuven, Belgium