Babesia Testing in Blood Donors

This study is currently recruiting participants.

Verified February 2012 by Imugen

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

History of Changes

Tracking Information

First Received Date ^ICMJE

January 31, 2012

Last Updated Date

February 14, 2012

Start Date ^ICMJE

December 2011

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

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

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 ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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:

- PCR, to look for the presence of B.microti in whole blood
- 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

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Arm (s)

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

Publications *

Not Provided

* 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

Recruiting

Estimated Enrollment ^ICMJE

26000

Estimated Completion Date

June 2013

Estimated Primary Completion Date

December 2012 (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

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01528449

Other Study ID Numbers ^ICMJE

BNATIFA-10

Has Data Monitoring Committee

Responsible Party

Imugen

Study Sponsor ^ICMJE

Imugen

Collaborators ^ICMJE

American Red Cross
Memorial Blood Centers, Minnesota
Rhode Island Blood Center

Investigators ^ICMJE

Principal Investigator:

Philip J Molloy, MD

Imugen Medical Director

Information Provided By

Imugen

Verification Date

February 2012

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

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