Detecting Infections Rapidly and Easily for Bacteremia Trial (DIREBT)

NCT01919762 | Completed

• 1 other identifier: PRO-00191
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacteremia

Keywords

Bacteremia; Sepsis; Acinetobacter baumannii; Staphylococcus aureus; Klebsiella pneumonia; Pseudomonas aeruginosa; Enterococcus faecalis; Magnetic Relaxation Detection; Nuclear Magnetic Resonance Detection; Blood culture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of bacteremia negative patients

  3-5 Days post blood culture

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with blood culture results are eligible to participate

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• T2 Biosystems: lead

Study Sites (1)

Cooper Medical School

Camden, New Jersey, 08103, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood specimens, in addition to bacterial isoaltes

MeSH Terms

Conditions

Bacteremia; Sepsis; Staphylococcal Infections; Pseudomonas Infections

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gram-Positive Bacterial Infections; Gram-Negative Bacterial Infections

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2013
• First Posted: August 9, 2013
• Study Start: August 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 28, 2015

Record last verified: 2015-09

Locations

US (1)