BurnsPCR-StaphNCT01140269
Rapid Detection of Staphylococcus Aureus in Burn Patients
A study testing PCR test in people with Burns and Sepsis, run by American Burn Association at 4 sites in United States.
Trial summary
The purpose of this study is to determine if rapid early detection of the bacteria causing sepsis in burn patients improves patient outcomes. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- What is being tested?
- PCR test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 4 sitesUnited States
- Study dates
- 30 May 2010to 29 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20% or > TBSA burns at hospital admission
- will require BC during hospital stay
- Patient/surrogate able to sign consent
Who cannot join
- allergic to nafcillin, cefazolin, vancomycin, linezolid, and/or daptomycin
- on antibiotic(s) prior to first BC
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Cincinnati Medical Center
Cincinnati, Ohio, 45221
University of Miami Health System
Miami, Florida, 33136
University of California Davis Medical Center-Regional Burn Center
Sacramento, California, 95817
Harborview Medical Center
Seattle, Washington, 98104
About this study
Official title: Rapid, Quantitative, PCR-Based Detection Of Staphylococcus Aureus in Burn Sepsis Patients
The purpose of this study is to determine if rapid early detection of the bacteria causing sepsis in burn patients improves patient outcomes.
Read the detailed description
Burn patients have lost their primary barrier to microorganism invasion and therefore are continually and chronically exposed to pathogens. Ninety-seven percent of patients with >20% total body surface area (TBSA) burns develop septicemia; predominantly involving gram positive cocci including MRSA and methicillin sensitive Staphylococcus aureus. Blood culture (BC) is the traditional detection method for septicemia. However, antibiotics and inadequate sample volumes can impair detection by BC and results can take 3-4 days.
Polymerase chain reaction (PCR) represents a potential adjunct to BC. Pathogens are detected in a growth-independent manner by targeting their genetic make-up. Quantitative determining of pathogen DNA using PCR could aid in determining antimicrobial drug therapy efficacy by providing results on the same testing day as opposed to 3-4 days with BC. PCR may also detect persistent infections during antimicrobial therapy when culture samples are inhibited.
The aims of this study are:(1)to correlate quantitative PCR results with that of the BC; (2) to test the clinical application of PCR results with clinical outcomes of treatment of presumptive diagnosis of staphylococcal sepsis.
- Being tested
- PCR test
- Keywords
- Burn, Sepsis, Infection
- Medical subject headings
- Burns, Sepsis, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCR testOther
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.
| Study group | Role | What they receive |
|---|---|---|
| No PCR testing | No intervention | Control patients will not have PCR testing. This group will have routine testing and treatment as defined by the standard of care. |
| PCR testing | Experimental | PCR 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. Receives: Other: PCR test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of PCR results with blood culture results
Measured: 72 hours after positive blood culture results
Secondary outcomes (3)
Duration of signs of infection
Measured: 14 days after the administrationof anti-Staphylococcus therapy
Duration of antibiotic use
Measured: 14 days after administration of antimicrobial therapy
Correlation of PCR result with mortality
Measured: Day 28 of intensive care unit stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2010 (estimated)
- Study start30 May 2010
- Primary completion29 Sep 2019
- Study completion29 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Burn Association
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Responsible party
- Sponsor
- Investigators
- Nam Tran, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01140269
- Sponsor's protocol ID
- ABA-MCTG-0002
- Acronym
- PCR-Staph
- Status last verified
- Aug 2023
- First submitted
- 4 Jun 2010
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid, Quantitative, PCR-Based Detection Of Staphylococcus Aureus in Burn Sepsis Patients
- ClinicalTrials.gov ID
- NCT01140269
- Acronym / sponsor ID
- PCR-Staph / ABA-MCTG-0002
- Keywords
- Burn, Sepsis, Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- American Burn AssociationUniversity, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Study start
- 30 May 2010 (actual)
- Primary completion
- 29 Sep 2019 (actual)
- Study completion
- 29 Sep 2019 (actual)
- First posted
- 9 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if rapid early detection of the bacteria causing sepsis in burn patients improves patient outcomes.
Detailed description
Burn patients have lost their primary barrier to microorganism invasion and therefore are continually and chronically exposed to pathogens. Ninety-seven percent of patients with >20% total body surface area (TBSA) burns develop septicemia; predominantly involving gram positive cocci including MRSA and methicillin sensitive Staphylococcus aureus. Blood culture (BC) is the traditional detection method for septicemia. However, antibiotics and inadequate sample volumes can impair detection by BC and results can take 3-4 days.
Polymerase chain reaction (PCR) represents a potential adjunct to BC. Pathogens are detected in a growth-independent manner by targeting their genetic make-up. Quantitative determining of pathogen DNA using PCR could aid in determining antimicrobial drug therapy efficacy by providing results on the same testing day as opposed to 3-4 days with BC. PCR may also detect persistent infections during antimicrobial therapy when culture samples are inhibited.
The aims of this study are:(1)to correlate quantitative PCR results with that of the BC; (2) to test the clinical application of PCR results with clinical outcomes of treatment of presumptive diagnosis of staphylococcal sepsis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No PCR testing | No intervention | –Control patients will not have PCR testing. This group will have routine testing and treatment as defined by the standard of care. |
| PCR testing | Experimental | Other: PCR testPCR 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 20% or > TBSA burns at hospital admission
- will require BC during hospital stay
- Patient/surrogate able to sign consent
Key exclusion criteria (2 listed)
- allergic to nafcillin, cefazolin, vancomycin, linezolid, and/or daptomycin
- on antibiotic(s) prior to first BC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCR testPCR 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. | Other | PCR testing |
Primary outcome
Correlation of PCR results with blood culture results
Time frame: 72 hours after positive blood culture results
3 secondary outcomes
Duration of signs of infection
Time frame: 14 days after the administrationof anti-Staphylococcus therapy
Duration of antibiotic use
Time frame: 14 days after administration of antimicrobial therapy
Correlation of PCR result with mortality
Time frame: Day 28 of intensive care unit stay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nam Tran, PhD principal investigator
University of California, Davis
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCR test in people with Burns and Sepsis, run by American Burn Association at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of PCR results with blood culture results (time frame: 72 hours after positive blood culture results). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.