Skip to main content
OpenTrials
Completed

NCT Number: NCT01528449

Babesia Testing in Blood Donors

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Transfusion Transmitted Babesiosis

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Imugen

Norwood, Massachusetts, 02062, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • same as for donating blood

Exclusion criteria

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

Treatment and study plan

B.microti diagnostic blood tests

Biological

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

Primary outcomes

  1. number of blood donors testing positive for evidence of Babesia infection

    Time frame: goal is up to one year (all specimens by end 2012)

Secondary outcomes

  1. the number of cases of transfusion transmitted babesia infection identified

    Time frame: goal is up to one year (all specimens by end 2012)

Sponsors and collaborators

Lead sponsor

Imugen

Industry

Collaborators

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

Registry information

Official study title

Blood Donation Screening for Babesia Microti by Real-time Polymerase Chain Reaction (PCR) and by Indirect Flourescent Antibody (IFA) Assays

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Feb 8, 2012
Registry last updated
Sep 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.