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NCT06537726Recruiting

Breath Analysis for the Detection of Invasive Fungal Infections

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

Source: ClinicalTrials.gov · Last updated 10 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Study type
Observational
Enrollment
130 (estimated)
First submitted
27 Jul 2024
Start date
19 Aug 2024
Primary completion date
31 Oct 2027
Lead sponsor
University of Zurich
NCT number
NCT06537726

What you commit to

  • Study type: Observational
  • Planned participants: 130
  • From 19 Aug 2024 to the primary completion date, 31 Oct 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Hospital of Zurich
Coordinator of this site? Confirm its status
ZurichSwitzerlandRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.