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NCT Number: NCT06537726

Breath Analysis for the Detection of Invasive Fungal Infections

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).

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Key information

Conditions

Leukemia Agranulocytosis Aspergillosis Bacterial Infections and Mycoses Chemotherapy-induced Neutropenia Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Infections Invasive Fungal Infections Invasive Pulmonary Aspergillosis Leukemia, Lymphoblastic Leukemia, Lymphoid Leukemia, Myeloid Leukocyte Disorders Leukopenia Lung Diseases Lung Diseases, Fungal Lymphatic Diseases Lymphoproliferative Disorders Mycoses Neoplasms Neoplasms by Histologic Type Neutropenia Precursor Cell Lymphoblastic Leukemia-Lymphoma Pulmonary Aspergillosis Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location status: Recruiting

Location contact

Egli Adrian, Prof. Dr.

SUB_INVESTIGATOR

Jeremy Deuel, PD Dr.

PRINCIPAL_INVESTIGATOR

Jeremy Deuel, PD Dr. Dr.

CONTACT

[email protected]

+41442551111

Kevin Hofer, Dr.

CONTACT

[email protected]

+41442551111

Kevin Hofer, Dr.

SUB_INVESTIGATOR

Noriane Sievi

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS)

Diagnostic Test

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: Blood sampling (serologic biomarkers, PCR), Sputum analysis, Low-dose CT

Primary outcomes

  1. Novel biomarker (m/z value) for IFI by SESI-HRMS

    Time frame: through study completion, on average after 3 weeks

    Feature in Mass Spectrometry

Secondary outcomes

  1. 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

  2. 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

Study contacts

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

Jeremy Deuel, PD Dr.

CONTACT

[email protected]

+41 44 255 11 11

Kevin Hofer, Dr.

CONTACT

[email protected]

+41 44 255 11 11

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Acronym: REDEFINE

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 5, 2024
Registry last updated
Apr 10, 2025

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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