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

NCT01695499 | Unknown

• 2 other identifiers: BAL-Biomarker-ICU StudyGrant Pfizer ASPIRE Award
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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 Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• immunocompetent patients (not fulfilling the criteria above)

Sponsors & Collaborators

• Heidelberg University: lead
• Pfizer: collaborator

Study Sites (1)

Mannheim University Hospital

Mannheim, 68167, Germany

Location

Related Publications (4)

• 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.

  PMID: 22740590 BACKGROUND

• 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.

  PMID: 22650156 BACKGROUND

• 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.

  PMID: 22526309 BACKGROUND

• 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.

  PMID: 30015290 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Only fungal DNA investigated

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr. Dieter Buchheidt

Study Record Dates

• First Submitted: September 26, 2012
• First Posted: September 28, 2012
• Study Start: August 1, 2012
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 20, 2020

Record last verified: 2020-04

Locations

DE (1)