Rapid Analysis of Infections by Spectrometry of Exhaled Breath (RAISE)

June 25, 2019 updated by: Universitaire Ziekenhuizen KU Leuven

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

246

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • Recruiting
        • University Hospitals Leuven
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients at high risk for opportunistic respiratory infections due to acute myeloid or lymphatic leukemia (undergoing intensive treatment), patients who underwent allogeneic stem cell transplantation, and patients receiving autologous stem cell transplantation

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion (i.e. 6 weeks after diagnosis)

Secondary Outcome Measures

Outcome Measure
Time Frame
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 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
6 weeks after diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2019

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

September 15, 2017

First Submitted That Met QC Criteria

September 27, 2017

First Posted (Actual)

October 3, 2017

Study Record Updates

Last Update Posted (Actual)

June 27, 2019

Last Update Submitted That Met QC Criteria

June 25, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S60785

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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