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Babesia Testing in Blood Donors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Imugen.
Recruitment status was  Recruiting
Sponsor:
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

January 31, 2012
February 14, 2012
December 2011
December 2012   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT01528449 on ClinicalTrials.gov Archive Site
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 ]
Not Provided
Not Provided
Not Provided
 
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

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

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

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Transfusion Transmitted Babesiosis
  • 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
  • Biological: B.microti diagnostic blood tests
    the interventions/procedures are investigational diagnostic tests for B.microti (PCR and IFA).
  • 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).
    Intervention: Biological: B.microti diagnostic blood 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).
    Intervention: Biological: B.microti diagnostic blood tests
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
26000
June 2013
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • same as for donating blood

Exclusion Criteria:

  • donor refusual to sign informed consent for this investigational babesia testing
Both
16 Years and older
Yes
United States
 
NCT01528449
BNATIFA-10
No
Imugen
Imugen
  • American Red Cross
  • Memorial Blood Centers, Minnesota
  • Rhode Island Blood Center
Principal Investigator: Philip J Molloy, MD Imugen Medical Director
Imugen
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP