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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Denver Health and Hospital Authority
Sponsor:
Collaborators:
Accelerate Diagnostics
Information provided by (Responsible Party):
Connie Price, Denver Health and Hospital Authority
ClinicalTrials.gov Identifier:
NCT02060513
First received: February 3, 2014
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Denver Health and Hospital Authority:

Primary Outcome Measures:
  • The proportion of concordant, accurately phenotyped positive isolates assayed by MADM versus conventional culture based microbiology as comparator. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Isolates of intresting bacteria


Estimated Enrollment: 20000
Study Start Date: August 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Inpatients with a suspected infection.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02060513

Contacts
Contact: Katie Overdier, BSc (Hons) 303 602 1479 Katie.Overdier@dhha.org

Locations
United States, Colorado
Denver Health Medical Center Recruiting
Denver, Colorado, United States, 80204
Principal Investigator: Connie S Price, MD         
Principal Investigator: Ivor S Douglas, MD         
Denver Veterans Affairs Eastern Colorado Health Care System Recruiting
Denver, Colorado, United States, 80220
Principal Investigator: Mary Bessesen, MD         
United States, Maryland
Washington Hospital Center Recruiting
Washington, Maryland, United States, 20782
Principal Investigator: Andrew Shorr, MD         
Sponsors and Collaborators
Connie Price
Accelerate Diagnostics
Investigators
Principal Investigator: Connie S Price, MD Denver Health Medical Center
Principal Investigator: Ivor S Douglas, MD Denver Health Medical Center
  More Information

No publications provided

Responsible Party: Connie Price, Associate Professor, Denver Health and Hospital Authority
ClinicalTrials.gov Identifier: NCT02060513     History of Changes
Other Study ID Numbers: 12-1580, W81XWH-12-2-0085
Study First Received: February 3, 2014
Last Updated: February 10, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Denver Health and Hospital Authority:
Wounded warriors
Battlefield infection
Acinetobacter
ESBL
MRSA
KPC

Additional relevant MeSH terms:
Bacterial Infections
Communicable Diseases
Infection

ClinicalTrials.gov processed this record on November 23, 2014