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

NCT01695499

Last updated date
Study Location
Mannheim University Hospital
Mannheim, , 68167, Germany
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
INvasive Aspergillosis, Mechanical Ventilation, Lung Infiltrates, Diagnostics, Biomarker
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-100 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- underlying conditions (see above)

- being on mechanical ventilation

- lung infiltrates

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- immunocompetent patients (not fulfilling the criteria above)

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INvasive Aspergillosis, Mechanical Ventilation, Lung Infiltrates, Diagnostics, BiomarkerDiagnostic Study of Biomarkers in BAL of ICU Patients With Lung Infiltrates
NCT01695499
  1. Mannheim,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Diagnostic Study of Biomarkers in BAL of ICU Patients With Lung Infiltrates
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
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Only fungal DNA investigated
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
Condition
  • INvasive Aspergillosis
  • Mechanical Ventilation
  • Lung Infiltrates
  • Diagnostics
  • Biomarker
Intervention Not Provided
Study 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: September 26, 2012)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • immunocompetent patients (not fulfilling the criteria above)
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT01695499
Other Study ID Numbers BAL-Biomarker-ICU Study
Grant Pfizer ASPIRE Award ( Other Grant/Funding Number: Pfizer Grant # WS 2274964 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dieter Buchheidt, Heidelberg University
Study Sponsor Heidelberg University
Collaborators Pfizer
Investigators Not Provided
PRS Account Heidelberg University
Verification Date April 2020