Study of Accuracy of New Diagnostic Technology to Determine Guide Rapid Antibiotic Treatment for Serious Infections
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/3/2016 |
| Start Date: | August 2013 |
| End Date: | November 2016 |
Rapid Microbiological Diagnostics for MDRO Quantitative Identification and Resistance Phenotyping to Guide Antibiotic Selection in Wounded Warriors and Veterans
Military service members and the U.S. veteran population face a growing and serious health
threat: widespread antibiotic resistance resulting from resistant bacteria and a dwindling
pipe-line of sufficiently potent antibiotics. Infections with antibiotic resistant bacteria
are increasing significantly. They cause major complications and mortality, and drive up
healthcare costs. Powerful but non-targeted antibiotics, while in widespread use, can
actually pressure bacteria to develop resistance.
threat: widespread antibiotic resistance resulting from resistant bacteria and a dwindling
pipe-line of sufficiently potent antibiotics. Infections with antibiotic resistant bacteria
are increasing significantly. They cause major complications and mortality, and drive up
healthcare costs. Powerful but non-targeted antibiotics, while in widespread use, can
actually pressure bacteria to develop resistance.
Current methods for diagnosing infections typically require 2-3 days to produce results that
can guide antibiotic choice. That is frequently too delayed to help clinicians make good
treatment decisions. This also results in inappropriate or over-treatment with non-targeted
antibiotics that are started while awaiting lab results. More rapid technologies that can
accurately diagnose the specific cause of an infection could guide early, targeted
antibiotic treatment. This would result in more effective early treatment of infection,
decrease unnecessary exposure to excess antibiotics, and could slow the development of
antibiotic resistance. By diagnosing infections earlier, we expect to reduce the
complications and mortality of combat-related infections in Wounded Warriors and Military
Veterans.
We propose a new ultra-rapid technology (called MADM) that uses a digital microscope to
detect bacteria growing directly from a patient's specimen, rather than waiting for growth
in lab cultures. The innovative new method supports identification of the infecting bacteria
within 2 hours of receiving a specimen. The technology 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.
This study involves collection of any excess volume of microbiology specimens after it has
been determined sufficient sample is available for clinical care. All microbiological
samples and results are being obtained for solely non-research purposes as part of usual
care; only leftover/discarded materials from clinical or research procedures already
performed will be used for this study. Samples will be tested in tandem with usual care on
the new technology to test the accuracy and speed. Results obtained from the new technology
will not be used in patient care or to make treatment decisions.
can guide antibiotic choice. That is frequently too delayed to help clinicians make good
treatment decisions. This also results in inappropriate or over-treatment with non-targeted
antibiotics that are started while awaiting lab results. More rapid technologies that can
accurately diagnose the specific cause of an infection could guide early, targeted
antibiotic treatment. This would result in more effective early treatment of infection,
decrease unnecessary exposure to excess antibiotics, and could slow the development of
antibiotic resistance. By diagnosing infections earlier, we expect to reduce the
complications and mortality of combat-related infections in Wounded Warriors and Military
Veterans.
We propose a new ultra-rapid technology (called MADM) that uses a digital microscope to
detect bacteria growing directly from a patient's specimen, rather than waiting for growth
in lab cultures. The innovative new method supports identification of the infecting bacteria
within 2 hours of receiving a specimen. The technology 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.
This study involves collection of any excess volume of microbiology specimens after it has
been determined sufficient sample is available for clinical care. All microbiological
samples and results are being obtained for solely non-research purposes as part of usual
care; only leftover/discarded materials from clinical or research procedures already
performed will be used for this study. Samples will be tested in tandem with usual care on
the new technology to test the accuracy and speed. Results obtained from the new technology
will not be used in patient care or to make treatment decisions.
Inclusion Criteria:
- Age ≥ 18 years old.
- Microbiology culture (respiratory, blood or tissue/skin) ordered during regular
clinical care.
Exclusion Criteria:
- Insufficient sample volume available after clinical test completed.
We found this trial at
3
sites
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777 Bannock St
Denver, Colorado 80204
Denver, Colorado 80204
(303) 436-6000
Principal Investigator: Connie S Price, MD
Denver Health Medical Center Denver Health is a comprehensive, integrated organization providing level one care...
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Denver, Colorado 80220
Principal Investigator: Mary Bessesen, MD
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