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

Denver Health and Hospital Authority

Status: Completed

Conditions: INFECTIONS; Infection Due to Resistant Bacteria; Healthcare-associated Infection; Skin and Subcutaneous Tissue Bacterial Infections

Treatments: Device: Testing on new technology called Accelerate ID/AST system

Study type: Observational

Funder types: Other; Industry; Other U.S. Federal agency

Identifiers

NCT02796716

14-1193

Details and patient eligibility

About

This research will test a new ultra-rapid technology (called ID/AST Accelerate system) that uses a digital microscope to identify bacteria based on their growth patterns. This method does not have to wait for bacteria to grow in a lab. The new method can identify the type of bacteria within 2 hours of receiving a specimen. The new method also shows the effect of selected antibiotics on the bacteria including multidrug resistant bacteria so that doctors know within 6 hours from specimen collection which antibiotic kills the bacteria.

To check the accuracy, speed and impact of the new method on antibiotic prescribing, investigators are proposing a study with two parts; The first part will test the accuracy and speed of the results obtained by the new method. The second part will test if having the results from the new method early would change the antibiotics prescribed to a patient in a simulation experiment. An independent infectious disease physician will be shown the results from the new method and asked if the results were accurate, would it change the antibiotic treatment for the patient.

Enrollment: 2,102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years old
• Remnant sample from available from microbiology culture (respiratory, blood or tissue/skin) ordered as part of usual clinical care.

Exclusion criteria

• Insufficient sample volume available after sufficient aliquot removed for usual care.