Febrile Whole Blood Specimen Collection and Testing

NCT03498027 | Completed FDA Device

• 1 other identifier: MRI-2017-004/5
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 3

Brief Summary

Whole blood samples will be collected from febrile patients presenting with fever of unknown origin and flu-like syndromes. Collection sites will consent patients and collect one (1) 4 mL whole blood sample from adults and either (1) 2 mL pediatric whole blood sample or 0.5 mL whole blood sample collected in a micro collection container from pediatric patients from each patient enrolled into the study. Study site will test whole blood samples received from collection sites daily using the Applied Biosystems™ Bacillus anthracis Detection Kit. Data generated will demonstrate product specificity when testing febrile whole blood samples.

Conditions

Febrile Infection; Anthrax

Outcome Measures

Primary Outcomes (1)

• Product Specificity

  Data generated will demonstrate product specificity when testing whole blood samples.

  1 day

Study Arms (1)

Data Collection

Device: TaqMan Bacillus anthracis Detection Kit

Interventions

TaqMan Bacillus anthracis Detection Kit DEVICE

The TaqMan® Bacillus anthracis Detection Kit is composed of the Applied Biosystems® 7500 Fast Dx Real-Time PCR Instrument with SDS Software, secondary interpretative software, and lyophilized reagents for the detection of gene targets for B. anthracis. The test assay is a multiplexed assay targeting gene targets for B. anthracis, in addition to an internal positive control. Reagents are lyophilized as a fully formulated Mastermix and are stable at room temperature for up to two years. The kit is specifically designed for performing real-time PCR using the Applied Biosystems® 7500 Fast Dx Real-Time PCR Instrument with SDS Software , with nucleic acids extracted from clinical specimens using Qiagen's QIAamp® Blood Midi Kit manual extraction or Roche MagNAPure automated extraction methods.

Data Collection

Eligibility Criteria

• Age: 2 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inclusion criteria to be documented on data form provided. * Fever of unknown origin * Flu like syndrome Age ranges of study participants is as follows: 2-15 Years of age 15-21 Years of age 22-40 Years of age \>40 Years of age

You may qualify if:

• Fever

You may not qualify if:

• None

Sponsors & Collaborators

• MRI Global: lead
• Department of Health and Human Services: collaborator

Study Sites (3)

Boca Biolistics

Tarpon Springs, Florida, 33319, United States

Location

New England Center for Clinical Research

Fall River, Massachusetts, 02720, United States

Location

Medical Research Network

Franklin, Massachusetts, 02038, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Febrile Whole Blood

MeSH Terms

Conditions

Anthrax

Condition Hierarchy (Ancestors)

Bacillaceae Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2018
• First Posted: April 13, 2018
• Study Start: July 26, 2018
• Primary Completion: October 18, 2018
• Study Completion: October 18, 2018
• Last Updated: December 19, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)