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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02060513
Recruitment Status : Completed
First Posted : February 12, 2014
Last Update Posted : December 2, 2016
United States Department of Defense
Accelerate Diagnostics, Inc.
Information provided by (Responsible Party):
Connie Price, Denver Health and Hospital Authority

Brief Summary:
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.

Condition or disease
Infection Skin and Subcutaneous Tissue Bacterial Infections Healthcare-associated Infection Infection Due to Resistant Bacteria

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 2298 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Rapid Microbiological Diagnostics for MDRO Quantitative Identification and Resistance Phenotyping to Guide Antibiotic Selection in Wounded Warriors and Veterans
Study Start Date : August 2013
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Primary Outcome Measures :
  1. The proportion of concordant, accurately phenotyped positive isolates assayed by MADM versus conventional culture based microbiology as comparator. [ Time Frame: 1 year ]

Biospecimen Retention:   Samples Without DNA
Isolates of intresting bacteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Inpatients with a suspected infection.

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT02060513

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United States, Colorado
Denver Health Medical Center
Denver, Colorado, United States, 80204
Denver Veterans Affairs Eastern Colorado Health Care System
Denver, Colorado, United States, 80220
United States, Maryland
Washington Hospital Center
Washington, Maryland, United States, 20782
Sponsors and Collaborators
Connie Price
United States Department of Defense
Accelerate Diagnostics, Inc.
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Principal Investigator: Connie S Price, MD Denver Health Medical Center
Principal Investigator: Ivor S Douglas, MD Denver Health Medical Center
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Responsible Party: Connie Price, Professor, Denver Health and Hospital Authority Identifier: NCT02060513    
Other Study ID Numbers: 12-1580
W81XWH-12-2-0085 ( Other Identifier: Department of Defense )
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: December 2, 2016
Last Verified: December 2016
Keywords provided by Connie Price, Denver Health and Hospital Authority:
Wounded warriors
Battlefield infection
Additional relevant MeSH terms:
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Communicable Diseases
Bacterial Infections
Cross Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes