Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
90116 participants
INTERVENTIONAL
2011-12-31
2014-09-30
Brief Summary
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Two laboratory methodologies will be utilized:
1. \- PCR, to look for the presence of B.microti in whole blood
2. \- IFA, to look for significant titers of B.microti antibody
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Detailed Description
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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
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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).
B.microti diagnostic blood tests
the interventions/procedures are investigational diagnostic tests for B.microti (PCR and IFA).
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).
B.microti diagnostic blood tests
the interventions/procedures are investigational diagnostic tests for B.microti (PCR and IFA).
Interventions
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B.microti diagnostic blood tests
the interventions/procedures are investigational diagnostic tests for B.microti (PCR and IFA).
B.microti diagnostic blood tests
the interventions/procedures are investigational diagnostic tests for B.microti (PCR and IFA).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
16 Years
ALL
Yes
Sponsors
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American National Red Cross
OTHER
Memorial Blood Centers, Minnesota
OTHER
Rhode Island Blood Center
UNKNOWN
Imugen
INDUSTRY
Responsible Party
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Principal Investigators
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Philip J Molloy, MD
Role: PRINCIPAL_INVESTIGATOR
Imugen Medical Director
Locations
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Imugen
Norwood, Massachusetts, United States
Countries
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References
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Moritz ED, Winton CS, Tonnetti L, Townsend RL, Berardi VP, Hewins ME, Weeks KE, Dodd RY, Stramer SL. Screening for Babesia microti in the U.S. Blood Supply. N Engl J Med. 2016 Dec 8;375(23):2236-2245. doi: 10.1056/NEJMoa1600897.
Other Identifiers
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BNATIFA-10
Identifier Type: -
Identifier Source: org_study_id
NCT01525030
Identifier Type: -
Identifier Source: nct_alias
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