Babesia Testing in Blood Donors
This study is currently recruiting participants.
Verified February 2012 by Imugen
Sponsor:
Imugen
Collaborators:
American Red Cross
Memorial Blood Centers, Minnesota
Rhode Island Blood Center
Information provided by (Responsible Party):
Imugen
ClinicalTrials.gov Identifier:
NCT01528449
First received: January 31, 2012
Last updated: February 14, 2012
Last verified: February 2012
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Transfusion Transmitted Babesiosis |
Biological: B.microti diagnostic blood tests |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Blood Donation Screening for Babesia Microti by Real-time Polymerase Chain Reaction (PCR) and by Indirect Flourescent Antibody (IFA) Assays |
Resource links provided by NLM:
Further study details as provided by Imugen:
Primary Outcome Measures:
- number of blood donors testing positive for evidence of Babesia infection [ Time Frame: goal is up to one year (all specimens by end 2012) ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- the number of cases of transfusion transmitted babesia infection identified [ Time Frame: goal is up to one year (all specimens by end 2012) ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 26000 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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).
|
Biological: B.microti diagnostic blood tests
the interventions/procedures are investigational diagnostic tests for B.microti (PCR and IFA).
Other Name: proprietary in-house developed PCR and IFA Babesia doagnostic tests
|
|
Experimental: prospective, real time
specimens from current blood donors will be tested and those testing positive for B.microti will not be released and 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).
|
Biological: B.microti diagnostic blood tests
the interventions/procedures are investigational diagnostic tests for B.microti (PCR and IFA).
|
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
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- same as for donating blood
Exclusion Criteria:
- donor refusual to sign informed consent for this investigational babesia testing
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01528449
Locations
| United States, Massachusetts | |
| Imugen | Recruiting |
| Norwood, Massachusetts, United States, 02062 | |
| Contact: Philip J Molloy, MD 781-255-0770 pjmolloy@imugen.com | |
| Contact: ed brissette 781-255-0770 ebrissette@imugen.com | |
| Principal Investigator: Philip J Molloy, MD | |
Sponsors and Collaborators
Imugen
American Red Cross
Memorial Blood Centers, Minnesota
Rhode Island Blood Center
Investigators
| Principal Investigator: | Philip J Molloy, MD | Imugen Medical Director |
More Information
No publications provided
| Responsible Party: | Imugen |
| ClinicalTrials.gov Identifier: | NCT01528449 History of Changes |
| Obsolete Identifiers: | NCT01525030 |
| Other Study ID Numbers: | BNATIFA-10 |
| Study First Received: | January 31, 2012 |
| Last Updated: | February 14, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Imugen:
|
babesia blood donation transfusion transmitted babesiosis |
Additional relevant MeSH terms:
|
Babesiosis Parasitic Diseases, Animal Parasitic Diseases |
Protozoan Infections, Animal Protozoan Infections Tick-Borne Diseases |
ClinicalTrials.gov processed this record on May 16, 2013