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

This study is currently recruiting participants.

Verified September 2012 by University of Heidelberg

Sponsor:

Collaborator:

Pfizer

Information provided by (Responsible Party):

Dieter Buchheidt, University of Heidelberg

ClinicalTrials.gov Identifier:

NCT01695499

First received: September 26, 2012

Last updated: NA

Last verified: September 2012

History: No changes posted

Purpose

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
INvasive Aspergillosis Mechanical Ventilation Lung Infiltrates Diagnostics Biomarker

Study Type:	Observational
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Aspergillosis

U.S. FDA Resources

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:

Diagnostic accuracy of combined biomarker testing in BAL fluid in relation to diagnostic certainty [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Evaluation of diagnostic accuracy of the combined biomarker approach

Biospecimen Retention: Samples With DNA

Only fungal DNA investigated

Estimated Enrollment:	200
Study Start Date:	August 2012
Estimated Study Completion Date:	March 2014
Estimated Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts
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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Immunocompromised patients on the intensive care unit with lun infiltrates and one of the following underlying conditions:

Underlying malignancy
Antineoplastic chemotherapy
Neutropenia
Allogeneic hematopoietic stem cell transplantation
Solid organ transplantation
Retransplantation
Acute or chronic immunological rejection or graft-versus-host-disease
Treatment with immunosuppressive agents (calcineurin inhibitors, OKT3, etc)
Profound systemic corticosteroid therapy prior to ICU admission
COPD Gold III/IV
Advanced liver cirrhosis and ICU treatment for more than 7 days
Hemodialysis, renal failure
CMV infection
HIV infection; CD4 cellcount
Post splenectomy
Post cardiac surgery
Diabetes mellitus
mechanical ventilation for more than 21 days
ICU-based steroid therapy and corticosteroid treatment for more than 7 days
Malnutrition
Severe burn wounds

Criteria

Inclusion Criteria:

underlying conditions (see above)
being on mechanical ventilation
lung infiltrates

Exclusion Criteria:

immunocompetent patients (not fulfilling the criteria above)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01695499

Locations

Germany
Mannheim University Hospital	Recruiting
Mannheim, Germany, 68167
Contact: Dieter Buchheidt, MD +49.621.383.4115 dieter.buchheidt@umm.de
Contact: Mark Reinwald, MD +49.621.383.4115 mark.reinwald@umm.de
Principal Investigator: Dieter Buchheidt, MD
Sub-Investigator: Mark Reinwald, MD

Sponsors and Collaborators

University of Heidelberg

Pfizer

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. 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. PubMed PMID: 22650156.

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. Epub 2012 Apr 23.

Responsible Party:	Dieter Buchheidt, Professor Dr. Dieter Buchheidt, University of Heidelberg
ClinicalTrials.gov Identifier:	NCT01695499 History of Changes
Other Study ID Numbers:	BAL-Biomarker-ICU Study, Grant Pfizer ASPIRE Award
Study First Received:	September 26, 2012
Last Updated:	September 26, 2012
Health Authority:	Germany: University of Heidelberg

Additional relevant MeSH terms:

Aspergillosis
Mycoses

ClinicalTrials.gov processed this record on June 18, 2013

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