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
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: 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 September 29, 2014