Diagnostic Study of Biomarkers in BAL of ICU Patients With Lung Infiltrates

• Sponsor: Heidelberg University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01695499
• Collaborator: Pfizer (Industry)
• Enrollment: 200
• Location: 1
• Duration (Months): 100
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

The aim of this project is therefore to explore on the clinical significance of analyzing surrogate markers combined with conventional diagnostics in the ICU setting. BAL, blood and biopsy samples will be subjected to a combined analysis of GM, BDG, Aspergillus specific PCR assays in addition to conventional diagnostics (Microscopy, Culture,Histology) for ICU pts with pulmonary infiltrates.

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.

Condition or Disease	Intervention/Treatment	Phase
INvasive Aspergillosis; Mechanical Ventilation; Lung Infiltrates; Diagnostics; Biomarker

Study Design

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Open, Prospective, Multicenter Trial to Evaluate the Clinical Significance of Combined Serological (Galactomannan ELISA, Beta D Glucan Assay) and Molecular (Nested Aspergillus PCR Assay, Real-time qPCR Assay, Multifungal DNA Microarray) Diagnostic Assays to Detect and Characterize Fungal Pathogens in Bronchoalveolar Lavage (BAL)and Blood Samples of Intensive Care Unit Patients With Pulmonary Infiltrates
• Study Start Date: Aug 1, 2012
• Anticipated Primary Completion Date: Dec 1, 2020
• Anticipated Study Completion Date: Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Immunosuppressed ICU Patients with lung infiltrates Immunosuppressed ICU Patients with lung infiltrates
Control Group BAL and blood aliquots of 20 immunocompetent pts (suffering from lung diseases) will be collected and tested identically as a control population.

Outcome Measures

Primary Outcome Measures

1. Diagnostic accuracy of combined biomarker testing in BAL fluid in relation to diagnostic certainty [6 weeks]

   Evaluation of diagnostic accuracy of the combined biomarker approach

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• underlying conditions (see above)

• being on mechanical ventilation

• lung infiltrates

Exclusion Criteria:

• immunocompetent patients (not fulfilling the criteria above)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mannheim University Hospital	Mannheim		Germany	68167

Sponsors and Collaborators

• Heidelberg University
• Pfizer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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-Flörl 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.

• Responsible Party: Dieter Buchheidt, Professor Dr. Dieter Buchheidt, Heidelberg University
• ClinicalTrials.gov Identifier: NCT01695499
• Other Study ID Numbers: BAL-Biomarker-ICU Study; Grant Pfizer ASPIRE Award
• First Posted: Sep 28, 2012
• Last Update Posted: Apr 20, 2020
• Last Verified: Apr 1, 2020

• Additional relevant MeSH terms: Aspergillosis

Study Results

No Results Posted as of Apr 20, 2020