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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
Phase
First received
Last updated
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
Health authority
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)

Study Design


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
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