T2Resistance - Detection of Resistance Related Genes

NCT05231187 | Completed FDA Device

• 1 other identifier: 210-11147
• Study Type: observational
• Target: 1,566
• Locations: 1 country
• Sites: 10

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of the T2Resistance Panel by validating clinical performance in three study arms:

1. 1.Prospective arm: positive percent agreement (PPA) and negative percent agreement (NPA) against genetic determinants of resistance detected in whole blood clinical samples or isolates collected from positive blood cultures prospectively collected clinical samples of whole blood.
2. 2.Contrived arm: positive percent agreement (PPA) and negative percent agreement (NPA) against samples with known status, via spiking healthy whole blood samples with bacterial strains harboring the resistance gene targets on the T2Resistance Panel.
3. 3.Healthy donor arm: negative percent agreement (NPA) with presumed negativity of healthy donor whole blood samples.

Conditions

Resistance Bacterial

Keywords

Antibiotic resistant markers

Outcome Measures

Primary Outcomes (3)

• Sensitivity - Prospective

  Positive concordance between positive T2Resistance panel results for positive samples.

  Six months from collection, maximum.

• Specificity - Prospective

  Negative concordance between a negative ("Target not Detected") result on the T2Resistance Panel and a negative sequencing result or a known negative sample.

  Six months from collection, maximum.

• Safety / Adverse Events

  Potential adverse events associated with the collection of blood samples for T2Resistance Panel Testing.

  During patient blood draw or immediately after blood draw, typically <1 hour.

Secondary Outcomes (2)

• Sensitivity - Contrived

  Six months from collection, maximum.

• Specificity - Contrived

  Six months from collection, maximum.

Study Arms (3)

Prospective Arm

Subjects has had a diagnostic blood culture ordered per routine standard of care.

Diagnostic Test: T2Resistance Panel

Contrived Arm

Samples of healthy whole blood spiked with bacterial strains harboring the resistance gene targets on the T2Resistance Panel.

Diagnostic Test: T2Resistance Panel

Healthy Donor Arm

Healthy donor subjects.

Diagnostic Test: T2Resistance Panel

Interventions

T2Resistance Panel DIAGNOSTIC_TEST

The T2Resistance Panel is an in vitro diagnostic medical device that runs on the T2Dx instrument and detects bacterial markers that are commonly associated with antibiotic resistance. T2Resistance Panel detects thirteen (13) markers of resistance in seven detection channels: 1. blaKPC 2. blaCTX-M 3. blaNDM / blaVIM / blaIMP 4. blaOXA-48 Group 5. vanA / vanB 6. mecA / mecC 7. AmpC (blaCMY / blaDHA)

Contrived Arm; Healthy Donor Arm; Prospective Arm

Eligibility Criteria

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

Study Population

Patients presenting at the Investigational Site (Hospital, Clinical) and having a diagnostic blood culture ordered per routine standard of care.

You may qualify if:

• Prospective Arm:
• Obtain informed consent according to institutional requirements, as needed.
• Patient has had a diagnostic blood culture ordered per routine standard of care.
• Patient is 18 years of age or older.

You may not qualify if:

• Prospective Arm
• Patient has other co-morbid condition(s) that, in the opinion of the Investigator, could limit the patient's ability to participate in the study or impact the scientific integrity of the study.
• Patient has had previous specimens tested for the T2Resistance Panel with valid results.

Sponsors & Collaborators

• T2 Biosystems: lead
• Biomedical Advanced Research and Development Authority: collaborator

Study Sites (10)

University of Alabama at Birmingham

Birmingham, Alabama, 352494, United States

Location

Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

University Health, Truman Medical Center

Kansas City, Missouri, 64108, United States

Location

New York University Langone Health

Brooklyn, New York, 11220, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

University of Texas Health Science Center

Houston, Texas, 77030, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood Samples.

Study Officials

• Roger Smith, Ph.D.

  T2 Biosystems

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: February 9, 2022
• Study Start: January 21, 2022
• Primary Completion: May 31, 2023
• Study Completion: April 24, 2024
• Last Updated: December 19, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)