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Generation of Standard Laboratory Values for Pneumococci Antibodies

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00567632
First Posted: December 5, 2007
Last Update Posted: January 17, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Johann Wolfgang Goethe University Hospital
  Purpose
The determination of reference values is a necessary basis for research and clinical routine testing for pneumococci antibodies

Condition
Reference Values

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Generation of Standard Laboratory Values for Pneumococci Antibodies

Further study details as provided by Johann Wolfgang Goethe University Hospital:

Primary Outcome Measures:
  • sufficient samples to calculate reference values [ Time Frame: 10(2006-10/2007) ]

Secondary Outcome Measures:
  • sufficient samples to correlate with screening assay [ Time Frame: 10/2006-10/2007 ]

Biospecimen Retention:   Samples Without DNA
human serum

Enrollment: 500
Study Start Date: October 2006
Study Completion Date: December 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Detailed Description:
This study is meant to determine specific pneumococcal antibodies stratified for age. The investigators also correlate our assay with the results from a commercially available pneumococcal screening ELISA (iGG1 and IgG2) in order to facilitate a screening for immunodeficiency, and to monitor the success of a performed immunization
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
any clinically and immunologically healthy subject of any age undergoing selective surgery
Criteria

Inclusion Criteria:

  • Subjects undergoing elective surgery

Exclusion Criteria:

  • Chronic illness condition,
  • Immunodeficiency
  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): NCT00567632


Locations
Germany
Goethe University, Department of Pulmonology
Frankfurt, Hessen, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Investigators
Study Chair: Markus A Rose, M.D., Ph.D., M.P.H Goethe University, childrens Hospital
  More Information

Responsible Party: Markus A. Rose, ass. Professor of Paediatrics, Goethe University, Childrens' Hospital
ClinicalTrials.gov Identifier: NCT00567632     History of Changes
Other Study ID Numbers: 1-Rose
First Submitted: December 4, 2007
First Posted: December 5, 2007
Last Update Posted: January 17, 2011
Last Verified: October 2007

Keywords provided by Johann Wolfgang Goethe University Hospital:
Pneumococci
Antibody
Standard laboratory values

Additional relevant MeSH terms:
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs