RNAseq Analysis of Microbial Gene Expression in Necrotizing Soft Tissue Infections

Necrotizing Soft Tissue Infections Clinical Trial

— NSTI  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02025816
• Other study ID #: L14-002
• Status: Completed
• Start date: December 2013
• Est. completion date: June 2019

Study information

• Verified date: December 2019
• Source: Texas Tech University Health Sciences Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: June 2019
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patient not willing to undergo additional tissue biopsies for RNA sequencing analysis

Related Conditions & MeSH terms

• Infection
• Necrotizing Soft Tissue Infections
• Soft Tissue Infections

Locations

Country	Name	City	State
United States	Texas Tech University Health Sciences Center/University Medical Center	Lubbock	Texas
United States	University Medical Center	Lubbock	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with non-culturable, anaerobic bacterial species colonization of NSTI		2-6 wks (duration of hospitalization)