Breath Analysis for the Detection of Invasive Fungal Infections (REDEFINE)

April 9, 2025 updated by: Jeremy Deuel, University of Zurich

Real-time Breath Analysis for the Detection of Invasive Fungal Infections in Neutropenic High-risk Patients

Patients with leukemia and concomitant neutropenia are at high risk of developing invasive fungal infections (IFI) that are associated with high morbidity and mortality. As these patients typically have severe thrombocytopenia, direct diagnostic sampling with invasive procedures is often not possible due to the high peri-interventional risk. Therefore, the presumptive diagnosis of IFI is primarily based on compatible lung findings on computed tomography and serologic detection of fungal cell wall components, which, however, have limited sensitivity and specificity.

With the present study, the investigators aim to determine a set of specific volatile biomarkers in leukemia patients with proven or probable IFI using secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

130

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 Contact Backup

Study Locations

  • Switzerland
      • Zürich, Switzerland, 8091
        • Recruiting
        • University Hospital of Zürich
        • Contact:
        • Contact:
        • Contact:
          • Jeremy Deuel, PD Dr.
        • Contact:
          • Kevin Hofer, Dr.
        • Contact:
          • Noriane Sievi
        • Contact:
          • Egli Adrian, Prof. Dr.

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with acute leukemia that are undergoing chemotherapy at the Department of Medical Oncology and Haematology at the University Hospital Zurich

Description

Inclusion Criteria:

  • Diagnosis of acute leukemia
  • Planned chemotherapy with a duration of hospitalisation of 2 weeks or longer
  • Neutropenia (<500/µl) present at inclusion or planned chemotherapy with expected neutropenia (<500/µl) for more than 7 days

Exclusion Criteria:

  • Unable to follow instructions for breath analysis
  • Anatomic abnormalities precluding the use of a mouthpiece for breath analysis

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
No invasive fungal disease
Patients, that retrospectively do not have evidence of IFI
Diagnostic test: Secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS)
Identify volatile biomarkers of IFI by analyzing the breath metabolome of patients with proven or probable IFI according to the criteria outlined by EORTC/MSG and controls.
Other Names:
  • Low-dose CT
  • Blood sampling (serologic biomarkers, PCR)
  • Sputum analysis
Possible invasive fungal disease
Patients, that retrospectively have a possible IFI (according to EORTC guidelines). There is suspicion of IFI by clinical or radiological features, but no microbiological evidence of IFI.
Diagnostic test: Secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS)
Identify volatile biomarkers of IFI by analyzing the breath metabolome of patients with proven or probable IFI according to the criteria outlined by EORTC/MSG and controls.
Other Names:
  • Low-dose CT
  • Blood sampling (serologic biomarkers, PCR)
  • Sputum analysis
Probable invasive fungal disease
Patients, that retrospectively have a probable IFI (according to EORTC guidelines). There is suspicion of IFI by clinical or radiological features, and indirect microbiological evidence of IFI.
Diagnostic test: Secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS)
Identify volatile biomarkers of IFI by analyzing the breath metabolome of patients with proven or probable IFI according to the criteria outlined by EORTC/MSG and controls.
Other Names:
  • Low-dose CT
  • Blood sampling (serologic biomarkers, PCR)
  • Sputum analysis
Proven invasive fungal disease
Patients, that retrospectively have a proven IFI (according to EORTC guidelines). There is histological (angioinvasive growth of a fungus) or definitive microbiological evidence of IFI, e.g. evidence of a fungus from a sterile tissue.
Diagnostic test: Secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS)
Identify volatile biomarkers of IFI by analyzing the breath metabolome of patients with proven or probable IFI according to the criteria outlined by EORTC/MSG and controls.
Other Names:
  • Low-dose CT
  • Blood sampling (serologic biomarkers, PCR)
  • Sputum analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Novel biomarker (m/z value) for IFI by SESI-HRMS
Time Frame: through study completion, on average after 3 weeks
Feature in Mass Spectrometry
through study completion, on average after 3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specificity and sensitivity of this novel biomarker
Time Frame: through study completion, on average after 3 weeks
Description of Accuracy and Precision of this novel biomarker
through study completion, on average after 3 weeks
Anticipation of IFI
Time Frame: through study completion, on average after 3 weeks
Timepoint of first detection in relation to first clinical symptoms of IFI
through study completion, on average after 3 weeks

Collaborators and Investigators

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

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Jeremy Deuel, PD Dr., University of Zurich

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)

August 19, 2024

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

October 31, 2027

Study Registration Dates

First Submitted

July 27, 2024

First Submitted That Met QC Criteria

August 2, 2024

First Posted (Actual)

August 5, 2024

Study Record Updates

Last Update Posted (Actual)

April 10, 2025

Last Update Submitted That Met QC Criteria

April 9, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNCTP000005947

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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