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

Infection Clinical Trial

— RAMPED  

Official title:

Rapid Microbiological Diagnostics for MDRO Quantitative Identification and Resistance Phenotyping to Guide Antibiotic Selection in Wounded Warriors and Veterans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02060513
• Other study ID #: 12-1580
• Secondary ID: W81XWH-12-2-0085
• Status: Completed
• Phase: N/A
• First received: February 3, 2014
• Last updated: December 1, 2016
• Start date: August 2013
• Est. completion date: November 2016

Study information

• Verified date: December 2016
• Source: Denver Health and Hospital Authority
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2298
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Cross Infection
• Healthcare-associated Infection
• Infection
• Infection Due to Resistant Bacteria
• Skin and Subcutaneous Tissue Bacterial Infections

Locations

Country	Name	City	State
United States	Denver Health Medical Center	Denver	Colorado
United States	Denver Veterans Affairs Eastern Colorado Health Care System	Denver	Colorado
United States	Washington Hospital Center	Washington	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Connie Price	Accelerate Diagnostics, Inc., United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of concordant, accurately phenotyped positive isolates assayed by MADM versus conventional culture based microbiology as comparator.		1 year	No