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

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ClinicalTrials.gov Identifier: NCT01919762
Recruitment Status : Completed
First Posted : August 9, 2013
Last Update Posted : September 28, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
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 Design

Study Type : Observational
Actual Enrollment : 156 participants
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)
Study Start Date : August 2013
Primary Completion Date : August 2015
Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. Number of bacteremia positive patients [ Time Frame: 3-5 days post blood culture ]
    Number of bacteria positive patients based on concordant, sequential blood culture results and a positive T2 signal


Secondary Outcome Measures :
  1. Number of bacteremia negative patients [ Time Frame: 3-5 Days post blood culture ]
    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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT01919762


Locations
United States, New Jersey
Cooper Medical School
Camden, New Jersey, United States, 08103
Sponsors and Collaborators
T2 Biosystems
More Information

Responsible Party: T2 Biosystems
ClinicalTrials.gov Identifier: NCT01919762     History of Changes
Other Study ID Numbers: PRO-00191
First Posted: August 9, 2013    Key Record Dates
Last Update Posted: September 28, 2015
Last Verified: September 2015

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
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes