BurnsNCT02323165
A New Method for Detection of Bacteria in the Bloodstream
An observational study of Burns and Wounds, run by University of Florida at 1 site in United States.
Trial summary
The primary aim is to determine if this new technique will detect and identify bacteria in the blood sooner than standard blood cultures or identify patients who may be septic without growing bacteria in their cultures. These will be correlated with the data collected from medical records on presumed sepsis. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Molecular Detection of Bacteria in the Bloodstream
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to 4 Mar 2022
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Identification of potential patients will take place during normal medical care of burn and wound patients admitted to the Burn Intensive Care Unit.
Who may be able to join
- Burn patient with ≥20 % total body surface area burns or non-burned wound care patient requiring wound care in the Burn Intensive Care Unit.
- Must weigh ≥ 50 kilograms
Who cannot join
- Pregnant or Lactating women
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida, Department of Anesthesia and Critical Care, Department of Surgery, Department of Pathology, Immunology and Laboratory Medicine in conjunction with UF Health at Shands Hosptial at the University of Florida
Gainesville, Florida, 32610
About this study
The primary aim is to determine if this new technique will detect and identify bacteria in the blood sooner than standard blood cultures or identify patients who may be septic without growing bacteria in their cultures. These will be correlated with the data collected from medical records on presumed sepsis. These results will be linked to data concerning infection that will be available as part of routine care including blood counts and other laboratory values that would be part of the routine medical care such as a white blood cell count. The earlier the bacteria are identified and the appropriate antimicrobials are administered the better the patient outcome.
Read the detailed description
This study will involve additional blood samples to be taken during the routine clinical blood draw, while the subject is being treated for their burn/wounds. The additional research samples will be examined for bacteria. A second blood draw will be performed at approximately 24 hours of initial blood collection. The blood is being collected and then correlate with results of routine medical care blood cultures and clinical status of the subject (diagnosis of sepsis, hemodynamic instability). Data that will be abstracted from the current electronic medical record includes whether there is any type of catheter indwelling (brand name and type), insertion methods including place of insertion (Intensive Care Unit, Operating Room, Emergency Department), adherence to bundle, complications during insertion, colonization of the subject with bacteria (MRSA), and culture results obtained as part of clinical care. Demographics (subject's age) and diagnoses will also be captured as some studies have shown a higher risk of infection with certain processes (burns) and percentage of burn.
- Being tested
- Molecular Detection of Bacteria in the Bloodstream
- Medical subject headings
- Burns, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molecular Detection of Bacteria in the BloodstreamOther
Extracted nucleic acid will be tested by Polymerase Chain Reaction (PCR) with universal bacterial 16 S amplifiers from known 16 S sequences that routinely contaminate reagents. Polymerase Chain Reaction (PCR) will be performed with both TaqMan assays to provide quantitative copy numbers, as well as traditional PCR that can produce products that can be sequenced to confirm bacterial species identification.
| Study group | Role | What they receive |
|---|---|---|
| Burns and Wound Care | Blood samples will be taken to detect and identify a molecular detection of bacteria in the bloodstream. In addition, data will be collected from the standard of care blood samples and compared. Receives: Other: Molecular Detection of Bacteria in the Bloodstream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of new molecular technique for the detection of bacteria in the blood stream. (Extracted nucleic acid will be tested by PCR)
Extracted nucleic acid will be tested by PCR with "universal" bacterial 16 S primers that we have identified as not amplifying a product from known 16 S sequences that routinely contaminate reagents.PCR will be performed by both TaqMan assays we have developed that can provide quantitative copy numbers, as well as traditional PCR that can produce products that can be sequenced to confirm bacterial species identification.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startJan 2015
- Primary completion4 Mar 2022
- Study completion4 Mar 2022
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.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brenda Fahy, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02323165
- Sponsor's protocol ID
- IRB201401005
- Status last verified
- Jul 2022
- First submitted
- 11 Dec 2014
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Method for Detection of Bacteria in the Bloodstream
- ClinicalTrials.gov ID
- NCT02323165
- Acronym / sponsor ID
- IRB201401005
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- 4 Mar 2022 (actual)
- Study completion
- 4 Mar 2022 (actual)
- First posted
- 23 Dec 2014 (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 primary aim is to determine if this new technique will detect and identify bacteria in the blood sooner than standard blood cultures or identify patients who may be septic without growing bacteria in their cultures. These will be correlated with the data collected from medical records on presumed sepsis. These results will be linked to data concerning infection that will be available as part of routine care including blood counts and other laboratory values that would be part of the routine medical care such as a white blood cell count. The earlier the bacteria are identified and the appropriate antimicrobials are administered the better the patient outcome.
Detailed description
This study will involve additional blood samples to be taken during the routine clinical blood draw, while the subject is being treated for their burn/wounds. The additional research samples will be examined for bacteria. A second blood draw will be performed at approximately 24 hours of initial blood collection. The blood is being collected and then correlate with results of routine medical care blood cultures and clinical status of the subject (diagnosis of sepsis, hemodynamic instability). Data that will be abstracted from the current electronic medical record includes whether there is any type of catheter indwelling (brand name and type), insertion methods including place of insertion (Intensive Care Unit, Operating Room, Emergency Department), adherence to bundle, complications during insertion, colonization of the subject with bacteria (MRSA), and culture results obtained as part of clinical care. Demographics (subject's age) and diagnoses will also be captured as some studies have shown a higher risk of infection with certain processes (burns) and percentage of burn.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Burns and Wound Care | – | Other: Molecular Detection of Bacteria in the BloodstreamBlood samples will be taken to detect and identify a molecular detection of bacteria in the bloodstream. In addition, data will be collected from the standard of care blood samples and compared. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Identification of potential patients will take place during normal medical care of burn and wound patients admitted to the Burn Intensive Care Unit.
Key inclusion criteria (2 listed)
- Burn patient with ≥20 % total body surface area burns or non-burned wound care patient requiring wound care in the Burn Intensive Care Unit.
- Must weigh ≥ 50 kilograms
Key exclusion criteria (2 listed)
- Pregnant or Lactating women
- Prisoners
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 |
|---|---|---|
| Molecular Detection of Bacteria in the BloodstreamExtracted nucleic acid will be tested by Polymerase Chain Reaction (PCR) with universal bacterial 16 S amplifiers from known 16 S sequences that routinely contaminate reagents. Polymerase Chain Reaction (PCR) will be performed with both TaqMan assays to provide quantitative copy numbers, as well as traditional PCR that can produce products that can be sequenced to confirm bacterial species identification. | Other | Burns and Wound Care |
Primary outcome
Efficacy of new molecular technique for the detection of bacteria in the blood stream. (Extracted nucleic acid will be tested by PCR)
Time frame: 6 months
Extracted nucleic acid will be tested by PCR with "universal" bacterial 16 S primers that we have identified as not amplifying a product from known 16 S sequences that routinely contaminate reagents.PCR will be performed by both TaqMan assays we have developed that can provide quantitative copy numbers, as well as traditional PCR that can produce products that can be sequenced to confirm bacterial species identification.
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 7 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Brenda Fahy, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burns and Wounds, run by University of Florida at 1 site 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 2 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 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Efficacy of new molecular technique for the detection of bacteria in the blood stream. (Extracted nucleic acid will be tested by PCR) (time frame: 6 months). 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 7 Jul 2022.