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

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ClinicalTrials.gov Identifier: NCT01695499
Recruitment Status : Enrolling by invitation
First Posted : September 28, 2012
Last Update Posted : May 8, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease
INvasive Aspergillosis Mechanical Ventilation Lung Infiltrates Diagnostics Biomarker

Study Design

Study Type : Observational
Estimated Enrollment : 200 participants
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
Study Start Date : August 2012
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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.


Outcome Measures

Primary Outcome Measures :
  1. Diagnostic accuracy of combined biomarker testing in BAL fluid in relation to diagnostic certainty [ Time Frame: 6 weeks ]
    Evaluation of diagnostic accuracy of the combined biomarker approach


Biospecimen Retention:   Samples With DNA
Only fungal DNA investigated

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 ( Other Grant/Funding Number: Pfizer Grant # WS 2274964 )
First Posted: September 28, 2012    Key Record Dates
Last Update Posted: May 8, 2017
Last Verified: May 2017

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