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

C

Connie Price

Status

Completed

Conditions

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

Study type

Observational

Funder types

Other
Industry
Other U.S. Federal agency

Identifiers

NCT02060513
12-1580
W81XWH-12-2-0085 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,298 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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