Necrotizing Soft Tissue InfectionsNSTINCT02025816
RNAseq Analysis of Microbial Gene Expression in Necrotizing Soft Tissue Infections
An observational study of Necrotizing Soft Tissue Infections, run by Texas Tech University Health Sciences Center at 2 sites in United States.
Trial summary
Hypothesis: We hypothesize that RNAseq will allow us to learn more about the causative agents of necrotizing soft tissue infections (NSTI) and risk factors involved in acquiring these devastating infections Tissue biopsies will be obtained from consented patients admitted with NSTI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Necrotizing Soft Tissue Infections
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2013to Jun 2019
- 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: Twenty to twenty five patients with necrotizing soft tissue infections (NSTI) admitted to the University Medical Center, Lubbock, TX
Who may be able to join
- Patient or LAR agrees to the procedure and signs informed consent form
- Patient is at least 18 yrs of age
- Patient has been diagnosed with an NSTI
Who cannot join
- Patient not willing to undergo additional tissue biopsies for RNA sequencing analysis
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Texas Tech University Health Sciences Center/University Medical Center
Lubbock, Texas, 79430
University Medical Center
Lubbock, Texas, 79430
About this study
Hypothesis: We hypothesize that RNAseq will allow us to learn more about the causative agents of necrotizing soft tissue infections (NSTI) and risk factors involved in acquiring these devastating infections
Tissue biopsies will be obtained from consented patients admitted with NSTI. Biopsies will be used for standard clinical analysis of bacterial species present or stored for later RNA sequencing. RNA sequencing will identify bacteria that are present within the infection site that may not be detected using standard culture techniques as well as reveal bacterial gene expression profiles within the NSTI site. Medical charts will also be reviewed for basic patient information as well as wound care management practices. We hope to identify bacterial species commonly present in these types of infections as well as risk factors predisposing individuals to NSTI's.
- Conditions
- Necrotizing Soft Tissue Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with non-culturable, anaerobic bacterial species colonization of NSTI
Measured: 2-6 wks (duration of hospitalization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionSep 2017
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotizing Soft Tissue InfectionsStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kendra Rumbaugh, PhD, Principal investigator, Texas Tech University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02025816
- Sponsor's protocol ID
- L14-002
- Acronym
- NSTI
- Status last verified
- Dec 2019
- First submitted
- 30 Dec 2013
- Last updated
- 9 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RNAseq Analysis of Microbial Gene Expression in Necrotizing Soft Tissue Infections
- ClinicalTrials.gov ID
- NCT02025816
- Acronym / sponsor ID
- NSTI / L14-002
- Conditions
- Necrotizing Soft Tissue Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 1 Jan 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.
Hypothesis: We hypothesize that RNAseq will allow us to learn more about the causative agents of necrotizing soft tissue infections (NSTI) and risk factors involved in acquiring these devastating infections
Tissue biopsies will be obtained from consented patients admitted with NSTI. Biopsies will be used for standard clinical analysis of bacterial species present or stored for later RNA sequencing. RNA sequencing will identify bacteria that are present within the infection site that may not be detected using standard culture techniques as well as reveal bacterial gene expression profiles within the NSTI site. Medical charts will also be reviewed for basic patient information as well as wound care management practices. We hope to identify bacterial species commonly present in these types of infections as well as risk factors predisposing individuals to NSTI's.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Twenty to twenty five patients with necrotizing soft tissue infections (NSTI) admitted to the University Medical Center, Lubbock, TX
Key inclusion criteria (3 listed)
- Patient or LAR agrees to the procedure and signs informed consent form
- Patient is at least 18 yrs of age
- Patient has been diagnosed with an NSTI
Key exclusion criteria (1 listed)
- Patient not willing to undergo additional tissue biopsies for RNA sequencing analysis
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
Percentage of patients with non-culturable, anaerobic bacterial species colonization of NSTI
Time frame: 2-6 wks (duration of hospitalization)
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 9 Dec 2019.
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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.
Kendra Rumbaugh, PhD principal investigator
Texas Tech University Health Sciences Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Necrotizing Soft Tissue Infections, run by Texas Tech University Health Sciences Center at 2 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 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 9 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Percentage of patients with non-culturable, anaerobic bacterial species colonization of NSTI (time frame: 2-6 wks (duration of hospitalization)). 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 9 Dec 2019.