Diagnostic Study of Biomarkers in BAL of ICU Patients With Lung Infiltrates
NCT ID: NCT01695499
Last Updated: 2020-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2012-08-31
2020-12-31
Brief Summary
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As GM and BDG are not species-specific, three established and repeatedly published species specific PCR-based assays (nested PCR, real time PCR assay, multifungal DNA Array)developed by our group will be investigated in combination with the serological tests in a multicenter prospective clinical diagnostic trial.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Immunosuppressed ICU Patients with lung infiltrates
Immunosuppressed ICU Patients with lung infiltrates
No interventions assigned to this group
Control Group
BAL and blood aliquots of 20 immunocompetent pts (suffering from lung diseases) will be collected and tested identically as a control population.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* being on mechanical ventilation
* lung infiltrates
Exclusion Criteria
18 Years
100 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Heidelberg University
OTHER
Responsible Party
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Dieter Buchheidt
Professor Dr. Dieter Buchheidt
Locations
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Mannheim University Hospital
Mannheim, , Germany
Countries
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References
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Reinwald M, Hummel M, Kovalevskaya E, Spiess B, Heinz WJ, Vehreschild JJ, Schultheis B, Krause SW, Claus B, Suedhoff T, Schwerdtfeger R, Reuter S, Kiehl MG, Hofmann WK, Buchheidt D. Therapy with antifungals decreases the diagnostic performance of PCR for diagnosing invasive aspergillosis in bronchoalveolar lavage samples of patients with haematological malignancies. J Antimicrob Chemother. 2012 Sep;67(9):2260-7. doi: 10.1093/jac/dks208. Epub 2012 Jun 27.
Reinwald M, Spiess B, Heinz WJ, Vehreschild JJ, Lass-Florl C, Kiehl M, Schultheis B, Krause SW, Wolf HH, Bertz H, Maschmeyer G, Hofmann WK, Buchheidt D. Diagnosing pulmonary aspergillosis in patients with hematological malignancies: a multicenter prospective evaluation of an Aspergillus PCR assay and a galactomannan ELISA in bronchoalveolar lavage samples. Eur J Haematol. 2012 Aug;89(2):120-7. doi: 10.1111/j.1600-0609.2012.01806.x. Epub 2012 Jun 22.
Spiess B, Seifarth W, Merker N, Howard SJ, Reinwald M, Dietz A, Hofmann WK, Buchheidt D. Development of novel PCR assays to detect azole resistance-mediating mutations of the Aspergillus fumigatus cyp51A gene in primary clinical samples from neutropenic patients. Antimicrob Agents Chemother. 2012 Jul;56(7):3905-10. doi: 10.1128/AAC.05902-11. Epub 2012 Apr 23.
Boch T, Reinwald M, Spiess B, Liebregts T, Schellongowski P, Meybohm P, Rath PM, Steinmann J, Trinkmann F, Britsch S, Michels JD, Jabbour C, Hofmann WK, Buchheidt D. Detection of invasive pulmonary aspergillosis in critically ill patients by combined use of conventional culture, galactomannan, 1-3-beta-D-glucan and Aspergillus specific nested polymerase chain reaction in a prospective pilot study. J Crit Care. 2018 Oct;47:198-203. doi: 10.1016/j.jcrc.2018.07.001. Epub 2018 Jul 4.
Other Identifiers
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Grant Pfizer ASPIRE Award
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
BAL-Biomarker-ICU Study
Identifier Type: -
Identifier Source: org_study_id
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