- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01646411
300 Antibody Diagnostic Test Kit (Antibody 300)
July 19, 2012 updated by: The Plasma Source
Phase I Study for Positive IgM Antibody Detection in New Diagnostic Test Kit for for Acute Phase Infection
For the development of a Point of Care IVD test kit for acute phase disease detection against a variety of bacterial and viral infections.
Phase one includes 100 clinical diagnosed positive and 200 clinically "normal" serum and whole blood matched specimens for specificity and sensitivity determination for each marker.
The positive samples must be IgM positive using any FDA cleared ELISA test kit.
The negatives samples must be negative for IgM.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pennsylvania
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Southampton, Pennsylvania, United States, 18966
- The Plasma Source
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with acute infection between the age of 18 and 70.
Sex and race are random.
Description
Inclusion Criteria:
- current acute infection
- age 18-70
- male or female
- any race
- currently active symptoms
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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assorted acute infection
300 patients diagnosed with assorted acute infection.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
IgM greater than 1xcut off value
Time Frame: Antibody value measured within seven days of specimen collection.
|
Elisa System positive results are greater than 1 times the cutoff. Negative less than 1x cutoff. Prevalence of IGM in general mid-atlantic population is less than 10% of study population. |
Antibody value measured within seven days of specimen collection.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Jeffery Flieshman, M.S immunology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (Anticipated)
December 1, 2012
Study Completion (Anticipated)
July 1, 2013
Study Registration Dates
First Submitted
July 12, 2012
First Submitted That Met QC Criteria
July 19, 2012
First Posted (Estimate)
July 20, 2012
Study Record Updates
Last Update Posted (Estimate)
July 20, 2012
Last Update Submitted That Met QC Criteria
July 19, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 300831
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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