NCT01662362

Brief Summary

The study is conducted to meet an FDA post market commitment to collect and report data on the performance of the ESA Chagas assay. A minimum of 50 donor specimens that are FDA-licensed ABBOTT PRISM Chagas repeatedly reactive (RR)will be tested with the ABBOTT ESA Chagas assay. In addition, minimum of 300 ABBOTT PRISM Chagas nonreactive (NR) unidentified donor specimens will be tested with ABBOTT ESA Chagas assay.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 8, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 10, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

February 20, 2014

Completed
Last Updated

February 20, 2014

Status Verified

January 1, 2014

Enrollment Period

5 months

First QC Date

August 8, 2012

Results QC Date

January 8, 2014

Last Update Submit

January 8, 2014

Conditions

Chagas Disease

Keywords

Chagas DiseaseTrypanosoma cruziAmerican trypanosomiasisSouth American trypanosomiasiskissing bugsreduviid bugs

Outcome Measures

Primary Outcomes (1)

  • ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas

    Up to six months

Secondary Outcomes (1)

  • ESA Testing of Preselected Donor Specimens Nonreactive by ABBOTT PRISM Chagas

    Up to six months

Study Arms (1)

Testing Donor Specimens with ESA Chagas

OTHER

Test blood donor specimens that are ABBOTT PRISM Chagas Repeatedly Reactive with ESA Chagas. Donors will be asked to return for a follow-up blood draw.

Device: Testing Donor Specimens with ESA Chagas

Interventions

Testing Donor Specimens with ESA ChagasDEVICE

Donors will be asked to return for a follow-up blood draw.

Also known as: ABBOTT ESA Chagas (ESA Chagas) assay, List Number: 8L34
Testing Donor Specimens with ESA Chagas

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Blood donor specimen documented as PRISM Chagas repeatedly reactive

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

LifeSource

Rosemont, Illinois, 60018, United States

Location

American Red Cross

Gaithersburg, Maryland, 20877, United States

Location

MeSH Terms

Conditions

Chagas Disease

Interventions

Biological Assay

Condition Hierarchy (Ancestors)

TrypanosomiasisEuglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsVector Borne Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

Title
Barbara Kaesdorf, Associate Director Clinical Affairs
Organization
Abbott
barbara.kaesdorf@abbott.com
847-937-8702

Study Officials

  • Susan Stramer, Ph.D.

    American National Red Cross

    PRINCIPAL INVESTIGATOR

  • Sharon Gordon, MS, MBA, MT

    LifeSource

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2012

First Posted

August 10, 2012

Study Start

July 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

February 20, 2014

Results First Posted

February 20, 2014

Record last verified: 2014-01

Locations

US(2)