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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Dieter Buchheidt, Heidelberg University
ClinicalTrials.gov Identifier:
NCT01695499
First received: September 26, 2012
Last updated: December 8, 2015
Last verified: December 2015
  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:


Further study details as provided by Heidelberg University:

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: December 2016
Estimated Primary Completion Date: December 2016 (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 to 100 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Mannheim University Hospital
Mannheim, Germany, 68167
Sponsors and Collaborators
Heidelberg University
Pfizer
  More Information

Publications:
Responsible Party: Dieter Buchheidt, Professor Dr. Dieter Buchheidt, Heidelberg University
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: December 8, 2015
Health Authority: Germany: University of Heidelberg

Additional relevant MeSH terms:
Aspergillosis
Dermatomycoses
Hyalohyphomycosis
Infection
Mycoses
Skin Diseases
Skin Diseases, Infectious

ClinicalTrials.gov processed this record on February 04, 2016