Clinical trial NCT03498027: Febrile Whole Blood Specimen Collection and Testing
Official title: Febrile Whole Blood Specimen Collection and Testing Protocol to Demonstrate Product Specificity for the Applied Biosystems™ Bacillus Anthracis Detection Kit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Febrile Infection
Anthrax
Lead sponsor: MRI Global
Sponsor class: INDUSTRY
Collaborators: name: Department of Health and Human Services
First posted: 2018-04-13
Enrollment: 97
Sex: ALL
Minimum age (years): 2
Maximum age (years): 89
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: Inclusion Criteria:

* Fever

Exclusion Criteria:

* None

Primary outcomes:
measure: Product Specificity
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Tarpon Springs
country: United States
facility: Boca Biolistics
state: Florida
city: Fall River
country: United States
facility: New England Center for Clinical Research
state: Massachusetts
city: Franklin
country: United States
facility: Medical Research Network
state: Massachusetts
Study officials:
References: