BurnsNCT00794742
Antimicrobial Resistance of Bacteria in Burn Patients
An observational study of Burns, run by Texas Tech University Health Sciences Center at 1 site in United States.
Trial summary
The purpose of this study is to test the resistance of pathogenic bacteria in infected tissues of burn patients to various antimicrobials and enzyme debriders. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Burns
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to May 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with open,unhealed,burn wounds
Who may be able to join
- Males and females of any age
- Have open, unhealed wounds(s) that will be cultured per standard of care
- Subject or authorized representative provide informed consent
Who cannot join
- Informed consent not provided or able to be obtained
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analyzing the Antimicrobial Resistance Profile of Bacterial Isolates Obtained From Severely Burned Patients
The purpose of this study is to test the resistance of pathogenic bacteria in infected tissues of burn patients to various antimicrobials and enzyme debriders.
Read the detailed description
Bacteria that is present in infected burn wounds will be isolated and identified. The isolates will be tested for resistance to commercially available antimicrobials.
- Conditions
- Burns
- Keywords
- Burn, Antimicrobial, Bacteria, Resistance, Biofilm, Pathogen
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Burn Wounds | Patients with burn wounds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Types of bacteria
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionMay 2014
- Study completionMay 2014
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Griswold, M.D., Principal investigator, Texas Tech University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00794742
- Sponsor's protocol ID
- TTUHSC-L09-014
- Status last verified
- Apr 2015
- First submitted
- 19 Nov 2008
- Last updated
- 13 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analyzing the Antimicrobial Resistance Profile of Bacterial Isolates Obtained From Severely Burned Patients
- ClinicalTrials.gov ID
- NCT00794742
- Acronym / sponsor ID
- TTUHSC-L09-014
- Conditions
- Burns
- Keywords
- Burn, Antimicrobial, Bacteria, Resistance, Biofilm, Pathogen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 20 Nov 2008 (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 test the resistance of pathogenic bacteria in infected tissues of burn patients to various antimicrobials and enzyme debriders.
Detailed description
Bacteria that is present in infected burn wounds will be isolated and identified. The isolates will be tested for resistance to commercially available antimicrobials.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Burn Wounds | – | –Patients with burn wounds |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with open,unhealed,burn wounds
Key inclusion criteria (3 listed)
- Males and females of any age
- Have open, unhealed wounds(s) that will be cultured per standard of care
- Subject or authorized representative provide informed consent
Key exclusion criteria (1 listed)
- Informed consent not provided or able to be obtained
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Types of bacteria
Time frame: 28 days
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 13 Apr 2015.
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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.
John Griswold, M.D. principal investigator
Texas Tech University Health Sciences Center
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, run by Texas Tech University Health Sciences Center 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 3 inclusion and 1 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 13 Apr 2015. 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?
Types of bacteria (time frame: 28 days). 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 13 Apr 2015.