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Sponsored by: |
Medical University of Graz |
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Information provided by: | Medical University of Graz |
ClinicalTrials.gov Identifier: | NCT00786903 |
In critically ill patients Candida spp. are frequently isolated from respiratory tract secretions such as endotracheal aspirates and bronchoalveolar lavages (BAL) and are most often considered as colonizers of the respiratory tract. In contrast, pneumonia due to infection with Candida spp. is rare and is diagnosed by histological demonstration of the yeast in lung tissue with associated inflammation. In spite of this, preemptive antifungal therapy based on isolation of Candida spp. from the respiratory tract is often initiated in critically ill patients. The disadvantages of this approach include increased selective pressure for the development of antimicrobial resistance, potential risks of adverse drug reactions and high treatment costs. On the other hand, immediate administration of appropriate antifungal therapy has been shown to be an important predictor of favorable outcome for patients with invasive fungal infections. Therefore, the development of reliable diagnostic measures for the detection of invasive pulmonary candidiasis is crucial.
The overall objective of the proposed research project is to identify diagnostic strategies to differentiate between Candida colonization and Candida infection of the lower respiratory tract in critically ill patients. The proposed projects intends to test the hypothesis that 1.) invasive Candida strains from the lower respiratory tract differ from colonizing Candida strains with regard to production and expression of putative virulence factors and/or that 2.) patients suffering from pulmonary invasive candidiasis differ from patients colonized by Candida spp. with regard to inflammatory markers, other serum markers (fungal antigen) and composition of indigenous pulmonary bacterial flora.
Condition |
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Invasive Candidiasis of the Lungs |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Candida Spp. in the Lower Respiratory Tract: Harmless Residents or Pathogen? |
Respiratory secretions, blood, lung tissue
Estimated Enrollment: | 350 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | November 2011 |
In critically ill patients Candida spp. are frequently isolated from respiratory tract secretions such as endotracheal aspirates and bronchoalveolar lavages (BAL) and are most often considered as colonizers of the respiratory tract. In contrast, pneumonia due to infection with Candida spp. is rare and is diagnosed by histological demonstration of the yeast in lung tissue with associated inflammation. In spite of this, preemptive antifungal therapy based on isolation of Candida spp. from the respiratory tract is often initiated in critically ill patients. The disadvantages of this approach include increased selective pressure for the development of antimicrobial resistance, potential risks of adverse drug reactions and high treatment costs. On the other hand, immediate administration of appropriate antifungal therapy has been shown to be an important predictor of favorable outcome for patients with invasive fungal infections. Therefore, the development of reliable diagnostic measures for the detection of invasive pulmonary candidiasis is crucial.
The overall objective of the proposed research project is to identify diagnostic strategies to differentiate between Candida colonization and Candida infection of the lower respiratory tract in critically ill patients. The proposed projects intends to test the hypothesis that 1.) invasive Candida strains from the lower respiratory tract differ from colonizing Candida strains with regard to production and expression of putative virulence factors and/or that 2.) patients suffering from pulmonary invasive candidiasis differ from patients colonized by Candida spp. with regard to inflammatory markers, other serum markers (fungal antigen) and composition of indigenous pulmonary bacterial flora. For this purpose, pathogen related factors such as Candida prevalence, Candida quantity, phospholipases, secreted aspartyl proteinases, chromosome length polymorphism, transcriptional profiles, DFG16, SAP1-3, and SAP5 mRNA as well as human cellular and serum markers such as Dectin-1, TLR-2, TLR-4, TNF-α, IL-2, IL-10, IL-12, procalcitonin and (1→3) ß-D-Glucan, the indigenous pulmonary bacterial flora and underlying risk factors will be investigated in 6 different patient groups in this project. The results of this study should contribute to a better understanding of Candida colonization and Candida infections in the lower respiratory tract in critically ill patients. This should prospectively lead to a more targeted antifungal therapy and to a better outcome as well as to a reduction of unnecessary antifungal treatments and to a reduction of treatment costs in the future.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
adult patients with and without infiltration of the lungs and with and without intubation and mechanically ventilation
Inclusion Criteria:
Exclusion Criteria:
Contact: Robert Krause, MD | +43316-385-2274 o. 81796 | robert.krause@meduni-graz.at |
Austria, Stmk | |
Medical University of Graz | Recruiting |
Graz, Stmk, Austria, 8043 | |
Contact: Robert Krause +43316-385-2274 o. 81796 robert.krause@medunigraz.at | |
Contact: Robert Krause +43316-385-2274 o. 81796 robert.krause@medunigraz.at |
Principal Investigator: | Robert Krause, MD | Medical University of Graz |
Responsible Party: | Medical University of Graz ( Robert Krause, MD ) |
Study ID Numbers: | 19-322 ex 07/08 |
Study First Received: | November 5, 2008 |
Last Updated: | March 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00786903 History of Changes |
Health Authority: | Austria: Agency for Health and Food Safety |
Mycoses Candidiasis Torulopsis |
Mycoses Candidiasis |