Clinical trial NCT02060513: Study of Accuracy of New Diagnostic Technology to Determine Guide Rapid Antibiotic Treatment for Serious Infections
Official title: Rapid Microbiological Diagnostics for MDRO Quantitative Identification and Resistance Phenotyping to Guide Antibiotic Selection in Wounded Warriors and Veterans
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection
Skin and Subcutaneous Tissue Bacterial Infections
Healthcare-associated Infection
Infection Due to Resistant Bacteria
Keywords: Wounded warriors
Battlefield infection
Acinetobacter
ESBL
MRSA
KPC
Lead sponsor: Denver Health and Hospital Authority
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: Accelerate Diagnostics, Inc.
First posted: 2014-02-12
Enrollment: 2298
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients with a suspected infection.

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.

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 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.

Primary outcomes:
measure: The proportion of concordant, accurately phenotyped positive isolates assayed by MADM versus conventional culture based microbiology as comparator.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
city: Denver
country: United States
facility: Denver Veterans Affairs Eastern Colorado Health Care System
state: Colorado
city: Washington
country: United States
facility: Washington Hospital Center
state: Maryland
Study officials:
affiliation: Denver Health Medical Center
name: Connie S Price, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Denver Health Medical Center
name: Ivor S Douglas, MD
role: PRINCIPAL_INVESTIGATOR
References: