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
  Purpose

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014