Detecting Infections Rapidly and Easily for Bacteremia Trial (DIREBT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by T2 Biosystems
Sponsor:
Information provided by (Responsible Party):
T2 Biosystems
ClinicalTrials.gov Identifier:
NCT01919762
First received: August 7, 2013
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

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.


Condition
Bacteremia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Detecting Infections Rapidly and Easily for Bacteremia Trial (DIREBT)-Part I (Prospective Collection and Freezing of Whole Blood Specimens)

Resource links provided by NLM:


Further study details as provided by T2 Biosystems:

Primary Outcome Measures:
  • Number of bacteremia positive patients [ Time Frame: 3-5 days post blood culture ] [ Designated as safety issue: No ]
    Number of bacteria positive patients based on concordant, sequential blood culture results and a positive T2 signal


Secondary Outcome Measures:
  • Number of bacteremia negative patients [ Time Frame: 3-5 Days post blood culture ] [ Designated as safety issue: No ]
    Number of negative bacteremia samples based on concordant, sequential blood culture results and a negative T2 signal


Biospecimen Retention:   Samples With DNA

Whole blood specimens, in addition to bacterial isoaltes


Estimated Enrollment: 700
Study Start Date: August 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with blood culture results are eligible to participate

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01919762

Locations
United States, New Jersey
Cooper Medical School Recruiting
Camden, New Jersey, United States, 08103
Contact: Mary Pileggi    856-757-9783    pileggi-mary@cooperhealth.edu   
Principal Investigator: Annette Reboli, MD         
Sponsors and Collaborators
T2 Biosystems
  More Information

No publications provided

Responsible Party: T2 Biosystems
ClinicalTrials.gov Identifier: NCT01919762     History of Changes
Other Study ID Numbers: PRO-00191
Study First Received: August 7, 2013
Last Updated: July 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by T2 Biosystems:
Bacteremia
Sepsis
Acinetobacter baumannii
Staphylococcus aureus
Klebsiella pneumonia
Pseudomonas aeruginosa
Enterococcus faecalis
Magnetic Relaxation Detection
Nuclear Magnetic Resonance Detection
Blood culture

Additional relevant MeSH terms:
Bacteremia
Bacterial Infections
Infection
Inflammation
Pathologic Processes
Sepsis
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on October 23, 2014