Babesia Testing in Blood Donors

Phase 3

Completed

• Conditions: Transfusion Transmitted Babesiosis
• Interventions: Biological: B.microti diagnostic blood tests

• Registration Number: NCT01528449
• Lead Sponsor: Imugen

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 Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-01-31
• Study First Submitted QC: 2012-02-07
• Study First Posted: 2012-02-08
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-11
• Last Update Posted: 2017-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90116

Inclusion Criteria

• same as for donating blood

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
retrospective	B.microti diagnostic blood tests	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).
prospective, real time	B.microti diagnostic blood tests	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).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
the number of cases of transfusion transmitted babesia infection identified	goal is up to one year (all specimens by end 2012)

Trial Locations

Locations (1)

Imugen; 🇺🇸 Norwood, Massachusetts, United States