Febrile Whole Blood Specimen Collection and Testing

• ClinicalTrials.gov Identifier: NCT03498027
• Recruitment Status: Completed
• First Posted: April 13, 2018
• Last Update Posted: December 19, 2018
• Sponsor: MRI Global
• Collaborator: Department of Health and Human Services
• Information provided by (Responsible Party): MRI Global

Study Description

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.

Condition or disease	Intervention/treatment
Febrile Infection; Anthrax	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 Design

• Study Type: Observational
• Actual Enrollment: 97 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Febrile Whole Blood Specimen Collection and Testing Protocol to Demonstrate Product Specificity for the Applied Biosystems™ Bacillus Anthracis Detection Kit
• Actual Study Start Date: July 26, 2018
• Actual Primary Completion Date: October 18, 2018
• Actual Study Completion Date: October 18, 2018

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

1. Product Specificity [ Time Frame: 1 day ]
   Data generated will demonstrate product specificity when testing whole blood samples.

Biospecimen Retention:   Samples With DNA

Febrile Whole Blood

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• Fever

Exclusion Criteria:

• None

Contacts and Locations

Locations

United States, Florida

Boca Biolistics

Tarpon Springs, Florida, United States, 33319

United States, Massachusetts

New England Center for Clinical Research

Fall River, Massachusetts, United States, 02720

Medical Research Network

Franklin, Massachusetts, United States, 02038

Sponsors and Collaborators

MRI Global

Department of Health and Human Services

More Information

• Responsible Party: MRI Global
• ClinicalTrials.gov Identifier: NCT03498027
• Other Study ID Numbers: MRI-2017-004/5
• First Posted: April 13, 2018
• Last Update Posted: December 19, 2018
• Last Verified: December 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

Additional relevant MeSH terms:

Anthrax; Hyperthermia; Fever; Body Temperature Changes; Heat Stress Disorders; Wounds and Injuries; Bacillaceae Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections