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Febrile Whole Blood Specimen Collection and Testing

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ClinicalTrials.gov Identifier: NCT03498027
Recruitment Status : Not yet recruiting
First Posted : April 13, 2018
Last Update Posted : April 13, 2018
Sponsor:
Collaborator:
Department of Health and Human Services
Information provided by (Responsible Party):
MRI Global

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 Type : Observational
Estimated Enrollment : 400 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
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

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.




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


Information from the National Library of Medicine

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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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498027


Contacts
Contact: Kristine Werking, PMP 321-308-6901 kwerking@mriglobal.org

Locations
United States, Massachusetts
NECCR Primacare Research, LLC Not yet recruiting
Fall River, Massachusetts, United States, 02721
Contact: Mark Bergeron    401-447-9121    mjbneccr@gmail.com   
Principal Investigator: Ehab Sorial, MD         
Sponsors and Collaborators
MRI Global
Department of Health and Human Services

Responsible Party: MRI Global
ClinicalTrials.gov Identifier: NCT03498027     History of Changes
Other Study ID Numbers: MRI-2017-004/5
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: April 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
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Fever
Anthrax
Body Temperature Changes
Signs and Symptoms
Bacillaceae Infections
Gram-Positive Bacterial Infections
Bacterial Infections