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Babesia Testing in Blood Donors

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ClinicalTrials.gov Identifier: NCT01528449
Recruitment Status : Completed
First Posted : February 8, 2012
Last Update Posted : September 12, 2017
Sponsor:
Collaborators:
American National Red Cross
Memorial Blood Centers, Minnesota
Rhode Island Blood Center
Information provided by (Responsible Party):
Imugen

Tracking Information
First Submitted Date  ICMJE January 31, 2012
First Posted Date  ICMJE February 8, 2012
Last Update Posted Date September 12, 2017
Study Start Date  ICMJE December 2011
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2012)
number of blood donors testing positive for evidence of Babesia infection [ Time Frame: goal is up to one year (all specimens by end 2012) ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT01528449 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2012)
the number of cases of transfusion transmitted babesia infection identified [ Time Frame: goal is up to one year (all specimens by end 2012) ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Babesia Testing in Blood Donors
Official Title  ICMJE Blood Donation Screening for Babesia Microti by Real-time Polymerase Chain Reaction (PCR) and by Indirect Flourescent Antibody (IFA) Assays
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Transfusion Transmitted Babesiosis
Intervention  ICMJE
  • 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).
Study Arms  ICMJE
  • 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 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).
    Intervention: Biological: B.microti diagnostic blood tests
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 25, 2015)
90116
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • same as for donating blood

Exclusion Criteria:

  • donor refusual to sign informed consent for this investigational babesia testing
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01528449
Other Study ID Numbers  ICMJE BNATIFA-10
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Imugen
Study Sponsor  ICMJE Imugen
Collaborators  ICMJE
  • American National Red Cross
  • Memorial Blood Centers, Minnesota
  • Rhode Island Blood Center
Investigators  ICMJE
Principal Investigator: Philip J Molloy, MD Imugen Medical Director
PRS Account Imugen
Verification Date September 2017

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