Generation of Standard Laboratory Values for Pneumococci Antibodies

This study has been completed.
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00567632
First received: December 4, 2007
Last updated: January 14, 2011
Last verified: October 2007
  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 Hospitals:

Primary Outcome Measures:
  • sufficient samples to calculate reference values [ Time Frame: 10(2006-10/2007) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • sufficient samples to correlate with screening assay [ Time Frame: 10/2006-10/2007 ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00567632

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

No publications provided

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
Study First Received: December 4, 2007
Last Updated: January 14, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on April 22, 2014