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

Mechanical Ventilation Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01695499
• Other study ID #: BAL-Biomarker-ICU Study
• Secondary ID: Grant Pfizer ASP
• Status: Enrolling by invitation
• Start date: August 2012
• Est. completion date: December 2020

Study information

• Verified date: April 2020
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• underlying conditions (see above)

• being on mechanical ventilation

• lung infiltrates

Exclusion Criteria:

• immunocompetent patients (not fulfilling the criteria above)

Related Conditions & MeSH terms

• Aspergillosis
• Biomarker
• Diagnostics
• INvasive Aspergillosis
• Lung Infiltrates
• Mechanical Ventilation

Locations

Country	Name	City	State
Germany	Mannheim University Hospital	Mannheim

Sponsors (2)

Lead Sponsor	Collaborator
Heidelberg University	Pfizer

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of combined biomarker testing in BAL fluid in relation to diagnostic certainty	Evaluation of diagnostic accuracy of the combined biomarker approach	6 weeks