Real-time breath analysis for early detection of invasive fungal infections in high-risk patients (REDEFINE)
Résumé de l'étude
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)
Intervention étudiée
Real-time breath analysis
(BASEC)
Maladie en cours d'investigation
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)
Critères d'exclusion
Inability to follow instructions for a breath analysis Anatomical abnormalities preventing the use of a mouthpiece (BASEC)
Lieu de l’étude
Zurich
(BASEC)
Sponsor
Jeremy Deuel, USZ
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Jeremy Deuel
+41 41 255 11 11
jeremy.deuel@clutterusz.chUniversitätsSpital Zürich Rämistrasse 100 8091 Zürich
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
14.06.2024
(BASEC)
Identifiant de l'essai ICTRP
non disponible
Titre officiel (approuvé par le comité d'éthique)
Real-time breath analysis for the detection of invasive fungal infections in neutropenic high-risk patients (REDEFINE) (BASEC)
Titre académique
non disponible
Titre public
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Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
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Plan de l'étude
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Critères d'inclusion/exclusion
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non disponible
Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai
Résumé des résultats
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Lien vers les résultats dans le registre primaire
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