Real-time breath analysis for early detection of invasive fungal infections in high-risk patients (REDEFINE)
Zusammenfassung der Studie
Invasive pulmonary fungal infections (IPF) are a complication of intensive chemotherapy used for patients with acute leukemia. This complication occurs in about 10% of patients. IPF leads to significant suffering and long-term damage as fungal growth destroys the lungs, often requiring surgical removal of the affected part for definitive healing. The diagnosis of IPF is challenging as a biopsy is usually necessary, which can also lead to complications. The available non-invasive tests are unsuitable for early detection of IPF, as they typically yield positive results only at advanced stages of the disease (if at all). Early detection of IPF would allow for early intensive antifungal therapy to curb the spread of the fungus. Therefore, the development of a non-invasive test for IPF is urgently needed. Real-time breath analysis is a harmless non-invasive method that has shown promising results as a candidate for early detection of IPF in preliminary studies. We therefore propose a larger study with patients at very high risk for IPF to test whether real-time breath analysis can indeed detect IPF early. Both patients at very high risk for IPF and the machine for breath analysis are available at our hospital. This study will answer the question of whether real-time breath analysis can detect IPF early to significantly improve diagnostics for IPF. The results will also serve as a basis for further studies that can test the effectiveness and safety of early intensive antifungal therapy for patients with early-stage IPF, so that the progression of lung destruction by the fungus can be prevented early.
(BASEC)
Untersuchte Intervention
Real-time breath analysis
(BASEC)
Untersuchte Krankheit(en)
Invasive pulmonary fungal infections (e.g., aspergillosis, mucormycosis) in patients with neutropenia
(BASEC)
Adult patients with acute leukemia Planned chemotherapy with hospitalization at the University Hospital Zurich for two weeks or more Neutropenia (<500/µl) at inclusion or expected neutropenia for more than 7 days. (BASEC)
Ausschlusskriterien
Inability to follow instructions for a breath analysis Anatomical abnormalities preventing the use of a mouthpiece (BASEC)
Studienstandort
Zürich
(BASEC)
Sponsor
Jeremy Deuel, USZ
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Jeremy Deuel
+41 41 255 11 11
jeremy.deuel@clutterusz.chUniversitätsSpital Zürich Rämistrasse 100 8091 Zürich
(BASEC)
Wissenschaftliche Auskünfte
nicht verfügbar
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
14.06.2024
(BASEC)
ICTRP Studien-ID
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Offizieller Titel (Genehmigt von der Ethikkommission)
Real-time breath analysis for the detection of invasive fungal infections in neutropenic high-risk patients (REDEFINE) (BASEC)
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Untersuchte Krankheit(en)
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