- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01528449
Babesia Testing in Blood Donors
Blood Donation Screening for Babesia Microti by Real-time Polymerase Chain Reaction (PCR) and by Indirect Flourescent Antibody (IFA) Assays
Both prospective and retrospective (look back) study of blood donors for laboratory evidence of babesia microti infection.
Two laboratory methodologies will be utilized:
- - PCR, to look for the presence of B.microti in whole blood
- - IFA, to look for significant titers of B.microti antibody
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Retrospective study will involve archived specimens from blood donors whose units have already been released and transfused into recipients.
Prospective study will be real time and units testing positive by either PCR or IFA will be not released and will be disgarded, and the donors advised and deferred from further blood donation
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Norwood, Massachusetts, United States, 02062
- Imugen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- same as for donating blood
Exclusion Criteria:
- donor refusual to sign informed consent for this investigational babesia testing
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: retrospective
archived specimens from blood donors whose units have already been released and transfused into recipients will be tested.
Attempts will be made to contact and obtain follow up specimens from both the donor and recipient of units initially testing positive for B.microti.
the interventions are investigational diagnostic tests for B.microti (PCR and IFA).
|
the interventions/procedures are investigational diagnostic tests for B.microti (PCR and IFA).
Other Names:
|
Experimental: prospective, real time
specimens from current blood donors will be tested and those testing positive for B.microti will not be released and the units will be disgarded, and the donors notified and deferred from future blood donation.
the interventions are investigational diagnostic tests for B.microti (PCR and IFA).
|
the interventions/procedures are investigational diagnostic tests for B.microti (PCR and IFA).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
number of blood donors testing positive for evidence of Babesia infection
Time Frame: goal is up to one year (all specimens by end 2012)
|
goal is up to one year (all specimens by end 2012)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the number of cases of transfusion transmitted babesia infection identified
Time Frame: goal is up to one year (all specimens by end 2012)
|
goal is up to one year (all specimens by end 2012)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Philip J Molloy, MD, Imugen Medical Director
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BNATIFA-10
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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