Generation of Standard Laboratory Values for Pneumococci Antibodies

Reference Values Clinical Trial

Official title:

Generation of Standard Laboratory Values for Pneumococci Antibodies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00567632
• Other study ID #: 1-Rose
• Status: Completed
• Phase: N/A
• First received: December 4, 2007
• Last updated: January 14, 2011
• Start date: October 2006
• Est. completion date: December 2010

Study information

• Verified date: October 2007
• Source: Johann Wolfgang Goethe University Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: December 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Subjects undergoing elective surgery

Exclusion Criteria:

• Chronic illness condition,

• Immunodeficiency

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Reference Values

Locations

Country	Name	City	State
Germany	Goethe University, Department of Pulmonology	Frankfurt	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospitals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sufficient samples to calculate reference values		10(2006-10/2007)	No
Secondary	sufficient samples to correlate with screening assay		10/2006-10/2007	No