RNAseq Analysis of Microbial Gene Expression in Necrotizing Soft Tissue Infections

NCT02025816 | Completed

• 1 other identifier: L14-002
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Necrotizing Soft Tissue Infections

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with non-culturable, anaerobic bacterial species colonization of NSTI

  2-6 wks (duration of hospitalization)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

Study Sites (2)

Texas Tech University Health Sciences Center/University Medical Center

Lubbock, Texas, 79430, United States

Location

University Medical Center

Lubbock, Texas, 79430, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tissue biopsies for RNAseq analysis of microbial gene expression

Study Officials

• Kendra Rumbaugh, PhD

  Texas Tech University Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2013
• First Posted: January 1, 2014
• Study Start: December 1, 2013
• Primary Completion: September 1, 2017
• Study Completion: June 1, 2019
• Last Updated: December 9, 2019

Record last verified: 2019-12

Locations

US (2)