Clinical Performance and Reproducibility of the Accelerate PhenoTest™ Blood Culture (BC) Kit With New Antibiotic Wave I Updates

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

731 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-11

Study Completion Date

2022-04-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a performance and reproducibility study to validate new or updated antimicrobials on the Accelerate PhenoTest™ BC kit. The data from this study will be used to support the submission to the FDA for clearance in the US and for global registrations of the device intended for in vitro diagnostic use.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Impact of Fast Phenotypic Antimicrobial Susceptibility Testing on Patients With Gram-Negative Rod Bacteremia

NCT03745014

Gram-negative Bacteremia

WITHDRAWN NA

Rapid Identification and Phenotypic Susceptibility Testing for Gram-Negative Bacteremia

NCT03218397

Gram-negative Bacteremia

COMPLETED NA

Study of Accuracy of New Diagnostic Technology to Determine Guide Rapid Antibiotic Treatment for Serious Infections

NCT02060513

Infection Skin and Subcutaneous Tissue Bacterial Infections Healthcare-associated Infection +1 more

COMPLETED

Pharmacokinetics and Pharmacodynamics and Selected Antibiotics During Pregnancy

NCT00214331

Pregnancy

COMPLETED

Value of the LightCycler® SeptiFast Test MGRADE for the Pathogen Detection in Neutropenic Hematological Patients

NCT01114165

Hematologic Diseases Neutropenia Febrile Neutropenia +1 more

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This clinical study entitled "Clinical Performance and Reproducibility of the Accelerate PhenoTest™ BC Kit Using the Accelerate Pheno™ System with New Antibiotic Wave I Updates for Antimicrobial Susceptibility Testing of Positive Blood Culture Specimens" is designed to demonstrate the clinical performance and reproducibility of the new or updated antimicrobials on the Accelerate PhenoTest™ BC kit, which was previously FDA-cleared in February 2017.

Clinical performance and reproducibility evaluations will be conducted at a minimum of three sites to determine the clinical performance of the new or updated antimicrobials from a combination of fresh (de-identified, remnant specimens) and contrived positive blood culture samples, to include at least 375 total specimens.

The study sites selected will have expertise in blood culture diagnostics and will be able to conduct the study in accordance with this protocol and Good Clinical Practices (GCP). Additionally, prior to study initiation, each site will have approval from the local Institutional Review Board (IRB).

It is anticipated that the data from this study will be used to support the submission to the FDA for clearance in the US and for global registrations of the device intended for in vitro diagnostic use.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bacteremia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Specimens that meet inclusion criteria

Intervention Type DEVICE

Specimens that have been de-identified and considered remnant by the laboratory (fresh specimens) or were contrived by the laboratory (using bacterial isolates with no identifying information) can be enrolled into the study.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Specimens that meet inclusion criteria

Specimens that have been de-identified and considered remnant by the laboratory (fresh specimens) or were contrived by the laboratory (using bacterial isolates with no identifying information) can be enrolled into the study.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Blood culture positivity is ≤ 8 hours prior to initiation of testing with the Accelerate Pheno™ system
* Positive blood culture sample containing gram-negative rods according to Gram stain results
* For fresh specimens, de-identified, remnant positive blood culture specimens from patients for which Standard of Care (SOC) testing has been initiated and the remaining samples would otherwise be discarded
* A minimum sample volume of 2.0 mL
* Seeded blood culture specimens derived from archived bacterial

Exclusion Criteria

* Blood culture positivity is \> 8 hours prior to initiation of testing with the Accelerate Pheno™ system
* Insufficient (less than 2.0 mL) remnant sample volume
* From a patient that has already been enrolled in the study
* Fresh samples from Mycobacterial-type blood culture media (BACTEC™ Myco/F Lytic, BacT/ALERT® MP Bottle, VersaTREK® Myco) or charcoal-containing media
* Seeded specimens that appear mixed (by Gram stain or purity plating) after bottle culture positivity

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes