Generation of Standard Laboratory Values for Pneumococci Antibodies

This study is ongoing, but not recruiting participants.

Sponsored by:	Johann Wolfgang Goethe University Hospitals
Information provided by:	Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:	NCT00567632

Purpose

The determination of reference values is a necessary basis for research and clinical routine testing for pneumococci antibodies

Condition
Reference Values

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, 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

Biospecimen Description:

human serum

Enrollment:	500
Study Start Date:	October 2006
Estimated Study Completion Date:	October 2007

Detailed Description:

Our study is meant to determine specific pneumococcal antibodies stratified for age. We 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, Hessen
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

Responsible Party:	Goethe University, Childrens' Hospital ( Markus A. Rose, ass. Professor of Paediatrics )
Study ID Numbers:	1-Rose
Study First Received:	December 4, 2007
Last Updated:	December 4, 2007
ClinicalTrials.gov Identifier:	NCT00567632
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Johann Wolfgang Goethe University Hospitals:

Pneumococci
Antibody
Standard laboratory values

Study placed in the following topic categories:

Antibodies
Immunoglobulins

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009