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
1 other identifier
interventional
90,116
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2011
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 31, 2012
CompletedFirst Posted
Study publicly available on registry
February 8, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedSeptember 12, 2017
September 1, 2017
2.8 years
January 31, 2012
September 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
number of blood donors testing positive for evidence of Babesia infection
goal is up to one year (all specimens by end 2012)
Secondary Outcomes (1)
the number of cases of transfusion transmitted babesia infection identified
goal is up to one year (all specimens by end 2012)
Study Arms (2)
retrospective
EXPERIMENTALarchived 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).
prospective, real time
EXPERIMENTALspecimens 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).
Interventions
the interventions/procedures are investigational diagnostic tests for B.microti (PCR and IFA).
Eligibility Criteria
You may qualify if:
- same as for donating blood
You may not qualify if:
- donor refusual to sign informed consent for this investigational babesia testing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Imugenlead
- American National Red Crosscollaborator
- Memorial Blood Centers, Minnesotacollaborator
- Rhode Island Blood Centercollaborator
Study Sites (1)
Imugen
Norwood, Massachusetts, 02062, United States
Related Publications (1)
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.
PMID: 27959685DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Philip J Molloy, MD
Imugen Medical Director
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2012
First Posted
February 8, 2012
Study Start
December 1, 2011
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
September 12, 2017
Record last verified: 2017-09