RNAseq Analysis of Microbial Gene Expression in Necrotizing Soft Tissue Infections (NSTI)

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 Overview

• Status: Completed
• Conditions: Necrotizing Soft Tissue Infections

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• United States
  • Texas
    • Lubbock, Texas, United States, 79430
      • Texas Tech University Health Sciences Center/University Medical Center
    • Lubbock, Texas, United States, 79430
      • University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Twenty to twenty five patients with necrotizing soft tissue infections (NSTI) admitted to the University Medical Center, Lubbock, TX

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients with non-culturable, anaerobic bacterial species colonization of NSTI	2-6 wks (duration of hospitalization)

Collaborators and Investigators

• Sponsor: Texas Tech University Health Sciences Center
• Investigators: Principal Investigator: Kendra Rumbaugh, PhD, Texas Tech University Health Sciences Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2013
• Primary Completion (ACTUAL): September 1, 2017
• Study Completion (ACTUAL): June 1, 2019

Study Registration Dates

• First Submitted: December 30, 2013
• First Submitted That Met QC Criteria: December 30, 2013
• First Posted (ESTIMATE): January 1, 2014

Study Record Updates

• Last Update Posted (ACTUAL): December 9, 2019
• Last Update Submitted That Met QC Criteria: December 6, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Soft Tissue Infections
• Other Study ID Numbers: L14-002