Rapid Detection of Staphylococcus Aureus in Burn Patients
PCR-Staph
Rapid, Quantitative, PCR-Based Detection Of Staphylococcus Aureus in Burn Sepsis Patients
1 other identifier
interventional
218
1 country
4
Brief Summary
The purpose of this study is to determine if rapid early detection of the bacteria causing sepsis in burn patients improves patient outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2010
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 30, 2010
CompletedFirst Submitted
Initial submission to the registry
June 4, 2010
CompletedFirst Posted
Study publicly available on registry
June 9, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 29, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 29, 2019
CompletedAugust 4, 2023
August 1, 2023
9.3 years
June 4, 2010
August 2, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Correlation of PCR results with blood culture results
72 hours after positive blood culture results
Secondary Outcomes (3)
Duration of signs of infection
14 days after the administrationof anti-Staphylococcus therapy
Duration of antibiotic use
14 days after administration of antimicrobial therapy
Correlation of PCR result with mortality
Day 28 of intensive care unit stay
Study Arms (2)
No PCR testing
NO INTERVENTIONControl patients will not have PCR testing. This group will have routine testing and treatment as defined by the standard of care.
PCR testing
EXPERIMENTALPCR will be used in parallel with routine laboratory tests such as culture. Treatment for PCR results will be based on the standard of care. Treatment of the patient will be dependent on the physician's clinical judgment based on existing clinical information including PCR, microbiology, patient physical presentation, and other laboratory results.
Interventions
PCR samples will test for Staphylococcus aureus (including MRSA) from wound swab and positive blood culture samples to augment treatment decisions. Serial PCR testing will follow after positive results to catalog pathogen loads over the course of treatment in a blinded fashion.
Eligibility Criteria
You may qualify if:
- % or \> TBSA burns at hospital admission
- will require BC during hospital stay
- Patient/surrogate able to sign consent
You may not qualify if:
- allergic to nafcillin, cefazolin, vancomycin, linezolid, and/or daptomycin
- on antibiotic(s) prior to first BC
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
University of California Davis Medical Center-Regional Burn Center
Sacramento, California, 95817, United States
University of Miami Health System
Miami, Florida, 33136, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45221, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nam Tran, PhD
University of California, Davis
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2010
First Posted
June 9, 2010
Study Start
May 30, 2010
Primary Completion
September 29, 2019
Study Completion
September 29, 2019
Last Updated
August 4, 2023
Record last verified: 2023-08