Detecting Infections Rapidly and Easily for Bacteremia Trial (DIREBT) (DIREBT)

Detecting Infections Rapidly and Easily for Bacteremia Trial (DIREBT)-Part I (Prospective Collection and Freezing of Whole Blood Specimens)

To assure the uniform collection, handling, storage and transport of patient whole blood specimens and associated information to support validation of the T2 Bacteremia Assay.

Study Overview

• Status: Completed
• Conditions: Bacteremia

Detailed Description

This protocol is intended for use by external sites collecting clinical research specimens for T2 Biosystems' use in developing the T2Bacterial Assay. Specimens and information on patients' medical history, blood properties, medications, and blood culture history/results are required from the T2Bacterial Assay's target patient population (i.e., candidates for blood culture). Ideally, clinical specimens for use in developing the T2Bacterial Assay will be collected from negative blood culture, positive non-bacteria blood culture and positive bacteria blood culture patients.

• Study Type: Observational
• Enrollment (Actual): 156

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with blood culture results are eligible to participate

Description

Inclusion Criteria:

• Subject or subject's authorized representative must be able to understand, read and sign the study specific informed consent form after the nature of the study has been fully explained to them.
• Males and females 18 - 95 years of age.

For Group A,

• Subject is confirmed to have bacteremia (gram negative rods, gram negative coccobacillus, and/or gram positive cocci) as evidenced by a positive diagnostic blood culture
• Subsequent species identification identifies the presence of one of the following 6 species of bacteria:
• Acinetobacter baumannii
• Staphylococcus aureus
• Klebsiella pneumonia
• Pseudomonas aeruginosa
• Enterococcus faecalis
• Enterococcus faecium

For Group B,

• Males and females 18 - 95 years of age.
• Subject is confirmed to not have bacteremia from the 6 bacteria species targeted by this study, as evidenced by diagnostic blood culture and subsequent species identification.

Exclusion Criteria:

• Use of any novel (i.e. not commercially available) drug compound within 30 days prior to the collection of T2 blood specimens.
• Subject has other co-morbid condition(s) that, in the opinion of the Investigator, could limit the subject's ability to participate in the study or impact the scientific integrity of the study.
• Subject has had an anti-bacterial drug administered through the same port or central line as is used to collect the clinical research specimens. A line draw cannot be used to obtain a study sample if an antibacterial agent was administered intravenously within the last 72 hours, unless the site can specifically document that a different line was used to administer the anti-bacterial agent.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Bacteremia Positive Patients; Symptomatic adult patients, confirmed via diagnostic blood culture and species identification followed by subsequent second blood culture results and species identification that are positive for each of the following species of bacteria (Target 6 Species).; Acinetobacter baumannii; Staphylococcus aureus; Klebsiella pneumonia; Pseudomonas aeruginosa; Enterococcus faecalis; Enterococcus faecium
Bacteremia Negative Patients; Adult patients confirmed via diagnostic blood culture and species identification and subsequent second blood culture and species identification as being negative for the Target 6 species

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of bacteremia positive patients	Number of bacteria positive patients based on concordant, sequential blood culture results and a positive T2 signal	3-5 days post blood culture

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of bacteremia negative patients	Number of negative bacteremia samples based on concordant, sequential blood culture results and a negative T2 signal	3-5 Days post blood culture

Collaborators and Investigators

• Sponsor: T2 Biosystems

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: August 7, 2013
• First Submitted That Met QC Criteria: August 7, 2013
• First Posted (Estimate): August 9, 2013

Study Record Updates

• Last Update Posted (Estimate): September 28, 2015
• Last Update Submitted That Met QC Criteria: September 25, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Bacteremia; Enterococcus faecalis; Staphylococcus aureus; Sepsis; Pseudomonas aeruginosa; Acinetobacter baumannii; Blood culture; Klebsiella pneumonia; Magnetic Relaxation Detection; Nuclear Magnetic Resonance Detection
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Bacterial Infections; Bacterial Infections and Mycoses; Sepsis; Bacteremia
• Other Study ID Numbers: PRO-00191