Febrile Whole Blood Specimen Collection and Testing

Febrile Whole Blood Specimen Collection and Testing Protocol to Demonstrate Product Specificity for the Applied Biosystems™ Bacillus Anthracis Detection Kit

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.

Study Overview

• Status: Completed
• Conditions: Anthrax; Febrile Infection
• Intervention / Treatment: Device: TaqMan Bacillus anthracis Detection Kit

Detailed Description

Whole blood samples will be collected from febrile patients presenting with fever of unknown origin and flu-like syndromes. Collection sites will be advised of collection requirements specific to patient population with the goal of collecting samples form patient between the ages of 2-89 years of age. Samples collected will be de-identified and assigned a specific study number. Study numbers and labels will be provided to collection site by the study monitor. Samples must be shipped to MRIGlobal or designated study site on the day of collection.

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 (anticoagulant: K2EDTA or defined alternative) from each patient enrolled into the study. Patients may not be enrolled in the study more than once. Patients considered for enrollment will be logged on an enrollment log. Log must be reviewed by the site prior to considering a patient for study enrollment to confirm enrollment status. Samples collected will be de-identified and assigned a specific study number. Study numbers and labels will be provided to collection site by the study monitor.

Study site will accept or reject samples based on shipping verification procedures and then process samples acceptable for testing within 24 hours of receipt. Sample testing must be performed in accordance with the Applied Biosystems™ Bacillus anthracis Detection Kit instructions for use.

At study start, study site will test whole blood samples received from collection sites daily (e.g. Tuesday, Wednesday, Thursday, and Friday) using the Applied Biosystems™ Bacillus anthracis Detection Kit. No reference testing will be required since the study is designed only to demonstrate product specificity. Samples are assumed to be negative for Bacillus anthracis. A minimum of 50, but likely 100 febrile whole blood samples will be tested at MRIGlobal.

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

• Study Type: Observational
• Enrollment (Actual): 97

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tarpon Springs, Florida, United States, 33319
      • Boca Biolistics
  • Massachusetts
    • Fall River, Massachusetts, United States, 02720
      • New England Center for Clinical Research
    • Franklin, Massachusetts, United States, 02038
      • Medical Research Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 89 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

• Fever

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Data Collection

Device: TaqMan Bacillus anthracis Detection Kit; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Product Specificity	Data generated will demonstrate product specificity when testing whole blood samples.	1 day

Collaborators and Investigators

• Sponsor: MRI Global
• Collaborators: Department of Health and Human Services

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2018
• Primary Completion (Actual): October 18, 2018
• Study Completion (Actual): October 18, 2018

Study Registration Dates

• First Submitted: April 6, 2018
• First Submitted That Met QC Criteria: April 6, 2018
• First Posted (Actual): April 13, 2018

Study Record Updates

• Last Update Posted (Actual): December 19, 2018
• Last Update Submitted That Met QC Criteria: December 14, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Wounds and Injuries; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Body Temperature Changes; Heat Stress Disorders; Bacillaceae Infections; Hyperthermia; Fever; Anthrax
• Other Study ID Numbers: MRI-2017-004/5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes