Babesia Testing in Blood Donors
Phase 3
Completed
- Conditions
- Transfusion Transmitted Babesiosis
- Registration Number
- NCT01528449
- Lead Sponsor
- Imugen
- Brief 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
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90116
Inclusion Criteria
- same as for donating blood
Exclusion Criteria
- donor refusual to sign informed consent for this investigational babesia testing
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method number of blood donors testing positive for evidence of Babesia infection goal is up to one year (all specimens by end 2012)
- Secondary Outcome Measures
Name Time Method the number of cases of transfusion transmitted babesia infection identified goal is up to one year (all specimens by end 2012)
Trial Locations
- Locations (1)
Imugen
🇺🇸Norwood, Massachusetts, United States
Imugen🇺🇸Norwood, Massachusetts, United States