Reference ValuesNCT00567632
Generation of Standard Laboratory Values for Pneumococci Antibodies
An observational study of Reference Values, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
The determination of reference values is a necessary basis for research and clinical routine testing for pneumococci antibodies Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Reference Values
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2006to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: any clinically and immunologically healthy subject of any age undergoing selective surgery
Who may be able to join
- Subjects undergoing elective surgery
Who cannot join
- Chronic illness condition,
- Immunodeficiency
Trial locations and contacts
1 site in 1 country.
Germany1 site
Goethe University, Department of Pulmonology
Frankfurt am Main, Hesse, 60590
About this study
The determination of reference values is a necessary basis for research and clinical routine testing for pneumococci antibodies
Read the 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
- Conditions
- Reference Values
- Keywords
- Pneumococci, Antibody, Standard laboratory values
What is being measured
The primary outcome is the main question the study is designed to answer.
sufficient samples to calculate reference values
Measured: 10(2006-10/2007)
Secondary outcomes (1)
sufficient samples to correlate with screening assay
Measured: 10/2006-10/2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2007 (estimated)
- Study startOct 2006
- Primary completionOct 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reference ValuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Markus A Rose, M.D., Ph.D., M.P.H, Study chair, Goethe University, childrens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00567632
- Sponsor's protocol ID
- 1-Rose
- Status last verified
- Oct 2007
- First submitted
- 4 Dec 2007
- Last updated
- 17 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generation of Standard Laboratory Values for Pneumococci Antibodies
- ClinicalTrials.gov ID
- NCT00567632
- Acronym / sponsor ID
- 1-Rose
- Conditions
- Reference Values
- Keywords
- Pneumococci, Antibody, Standard laboratory values
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 5 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The determination of reference values is a necessary basis for research and clinical routine testing for pneumococci antibodies
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- any clinically and immunologically healthy subject of any age undergoing selective surgery
Key inclusion criteria (1 listed)
- Subjects undergoing elective surgery
Key exclusion criteria (2 listed)
- Chronic illness condition,
- Immunodeficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
sufficient samples to calculate reference values
Time frame: 10(2006-10/2007)
1 secondary outcome
sufficient samples to correlate with screening assay
Time frame: 10/2006-10/2007
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus A Rose, M.D., Ph.D., M.P.H study chair
Goethe University, childrens Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Reference Values, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sufficient samples to calculate reference values (time frame: 10(2006-10/2007)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2011.