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NCT Number: NCT03299608

Rapid Analysis of Infections by Spectrometry of Exhaled Breath

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

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Key information

Conditions

Respiratory Tract Infections Hematologic Diseases Hemic and Lymphatic Diseases Infections Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Breath analysis

Diagnostic Test

Spectrometric analysis of exhaled breath as screening for opportunistic respiratory infections

Primary outcomes

  1. Diagnostic accuracy

    Time frame: 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 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

Study contacts

Contact information is provided by the study sponsor or research team.

Toine Mercier, MD

CONTACT

[email protected]

+32 16 34 00 04

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Acronym: RAISE

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Oct 3, 2017
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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