Babesia Testing in Blood Donors

September 11, 2017 updated by: Imugen

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

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

90116

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Norwood, Massachusetts, United States, 02062
        • Imugen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • same as for donating blood

Exclusion Criteria:

  • donor refusual to sign informed consent for this investigational babesia testing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).
the interventions/procedures are investigational diagnostic tests for B.microti (PCR and IFA).
Other Names:
  • 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 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).
the interventions/procedures are investigational diagnostic tests for B.microti (PCR and IFA).
Other Names:
  • proprietary in-house developed PCR and IFA Babesia doagnostic tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of blood donors testing positive for evidence of Babesia infection
Time Frame: goal is up to one year (all specimens by end 2012)
goal is up to one year (all specimens by end 2012)

Secondary Outcome Measures

Outcome Measure
Time Frame
the number of cases of transfusion transmitted babesia infection identified
Time Frame: goal is up to one year (all specimens by end 2012)
goal is up to one year (all specimens by end 2012)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Philip J Molloy, MD, Imugen Medical Director

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

January 31, 2012

First Submitted That Met QC Criteria

February 7, 2012

First Posted (Estimate)

February 8, 2012

Study Record Updates

Last Update Posted (Actual)

September 12, 2017

Last Update Submitted That Met QC Criteria

September 11, 2017

Last Verified

September 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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