Babesia Testing in Blood Donors

NCT01528449 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90116

Last updated 2017-09-12

No results posted yet for this study

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

Conditions

  • Transfusion Transmitted Babesiosis

Interventions

BIOLOGICAL

B.microti diagnostic blood tests

the interventions/procedures are investigational diagnostic tests for B.microti (PCR and IFA).

BIOLOGICAL

B.microti diagnostic blood tests

the interventions/procedures are investigational diagnostic tests for B.microti (PCR and IFA).

Sponsors & Collaborators

  • American National Red Cross

    collaborator OTHER
  • Memorial Blood Centers, Minnesota

    collaborator OTHER
  • Rhode Island Blood Center

    collaborator UNKNOWN
  • Imugen

    lead INDUSTRY

Principal Investigators

  • Philip J Molloy, MD · Imugen Medical Director

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01528449 on ClinicalTrials.gov