Babesia Testing in Blood Donors
NCT01528449 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90116
Last updated 2017-09-12
Summary
Both prospective and retrospective (look back) study of blood donors for laboratory evidence of babesia microti infection.
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
Conditions
- Transfusion Transmitted Babesiosis
Interventions
- BIOLOGICAL
-
B.microti diagnostic blood tests
the interventions/procedures are investigational diagnostic tests for B.microti (PCR and IFA).
- BIOLOGICAL
-
B.microti diagnostic blood tests
the interventions/procedures are investigational diagnostic tests for B.microti (PCR and IFA).
Sponsors & Collaborators
-
American National Red Cross
collaborator OTHER -
Memorial Blood Centers, Minnesota
collaborator OTHER -
Rhode Island Blood Center
collaborator UNKNOWN -
Imugen
lead INDUSTRY
Principal Investigators
-
Philip J Molloy, MD · Imugen Medical Director
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 16 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2011-12-31
- Primary Completion
- 2014-09-30
- Completion
- 2014-09-30
Countries
- United States
Study Locations
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