Study of Accuracy of New Diagnostic Technology to Guide Rapid Antibiotic Treatment for Serious Infections
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|ClinicalTrials.gov Identifier: NCT02796716|
Recruitment Status : Completed
First Posted : June 13, 2016
Last Update Posted : February 2, 2017
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.
|Condition or disease||Intervention/treatment|
|INFECTIONS Skin and Subcutaneous Tissue Bacterial Infections Healthcare-associated Infection Infection Due to Resistant Bacteria||Device: Testing on new technology called Accelerate ID/AST system|
|Study Type :||Observational|
|Actual Enrollment :||2102 participants|
|Official Title:||Rapid Microbiological Diagnostics for MDRO Quantitative Identification and Resistance Phenotyping to Guide Antibiotic Selection in Wounded Warriors and Veterans - Task 3|
|Study Start Date :||July 2015|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
- Difference in empiric antimicrobial use [ Time Frame: 1.5 years ]Antibiotic use from the time of specimen collection until antibiotic susceptibility testing results are available to treating clinicians. Antibiotic use will be measured in days of therapy (DOT). DOT in usual care and simulated ID/AST Accelerate system will be compared
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): NCT02796716
|United States, Colorado|
|Denver Health Medical Center|
|Denver, Colorado, United States, 80204|
|Principal Investigator:||Connie S Price, MD||Denver Health|
|Principal Investigator:||Ivor S Douglas, MD||Denver Health|