Procleix® Dengue Virus Assay Testing of Individual Donor Samples From Puerto Rican Blood Donors - American Red Cross

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Gen-Probe, Incorporated
Sponsor:
Information provided by (Responsible Party):
Gen-Probe, Incorporated
ClinicalTrials.gov Identifier:
NCT01656174
First received: July 31, 2012
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

The objective of this study is to test individual donor samples (IDSs) with the investigational Dengue Assay on the TIGRIS System and to further characterize the Dengue Assay in the clinical setting.


Condition Intervention
Dengue
Device: Procleix Dengue Virus Assay

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Procleix® Dengue Virus Assay Testing of Individual Donor Samples From Puerto Rican Blood Donors - American Red Cross

Resource links provided by NLM:


Further study details as provided by Gen-Probe, Incorporated:

Primary Outcome Measures:
  • Qualitative detection of ribosomal RNA from Dengue Virus in plasma specimens from individual human donors, including volunteer donors of whole blood and blood components, and other living donors. [ Time Frame: Approximately three years ] [ Designated as safety issue: No ]

Estimated Enrollment: 250000
Study Start Date: August 2012
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
No Treatment Device: Procleix Dengue Virus Assay
in vitro diagnostic assay

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

volunteer blood donors from Puerto Rico

Criteria

Inclusion Criteria:

  • Donor must meet all the blood collection sites' standard eligibility requirements.
  • Donor and/or legally authorized representative must be willing to undergo the site's routine informed consent process prior to study participation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01656174

Contacts
Contact: Amy Broulik, MAS 858-410-8515 amy.broulik@gen-probe.com

Locations
United States, Arizona
Creative Testing Solutions Completed
Tempe, Arizona, United States, 85282
United States, North Carolina
American Red Cross National Testing Laboratory Recruiting
Charlotte, North Carolina, United States, 28273
Contact: Susan Stramer, PhD    301-212-2801    Susan.stramer@redcross.org   
Principal Investigator: Susan Stramer, PhD         
Sponsors and Collaborators
Gen-Probe, Incorporated
Investigators
Study Director: Jennifer Reid, PhD Gen-Probe, Incorporated
  More Information

No publications provided

Responsible Party: Gen-Probe, Incorporated
ClinicalTrials.gov Identifier: NCT01656174     History of Changes
Other Study ID Numbers: DENVTS-US12-001
Study First Received: July 31, 2012
Last Updated: February 5, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dengue
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral

ClinicalTrials.gov processed this record on August 26, 2014