What this study is
Necrotizing soft tissue infection (NSTI) is a devastating disease that results in a high rate of in-hospital complications and despite advances in critical care, wound care, and early intervention, NSTI continues to be associated with a mortality rate of nearly 30%. The antibiotics used in this treatment are Clindamycin, Vancomycin, Piperacillin Tazobactam; these antibiotics may be administered combined or individually, based on individualized patient treatment. Although one of the tenets of management for NSTI is early broad-spectrum intravenous antibiotics (listed above), the duration of antibiotics needed is not well defined. Currently, there exists wide variation in the duration of antibiotics for NSTI ranging between 2-16 days. The objective of this study is to evaluate the safety of a shorter course of antibiotics hypothesizing that a short duration of antibiotics for 48-hours after source-control is achieved will have similar risk of morbidity and mortality compared to a 7-day course of antibiotics post source control. A second aim of this study will be to identify if serum procalcitonin levels/ratio correspond to resolution of systemic infection in patients with NSTI.
What's being tested
- Antibiotic duration (short course)
Intervention · OTHER
The patient will be enrolled in a 48-hour course of antibiotics.
- Antibiotic duration (extended course)
Intervention · OTHER
The patient will be enrolled in a 7 day course of antibiotics.
Study details
- Official title
- Pilot Randomized Controlled Trial of Shorter Versus Extended Course of Antibiotic Therapy for Necrotizing Soft Tissue Infections
- Sponsor
- University of California, Irvine
- Conditions
- Necrotizing Soft Tissue Infection
- Enrolling
- 50 people
- Starts
- 2023-12-28
- Est. completion
- 2026-12-01
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Adult patients 18 years of age or older with all following criteria:; Presenting to the Emergency Department with history, exam and/or imaging concerning NSTI, AND; Patients who undergo consultation by the Emergency General Surgery service, AND; Patients included must have skin or soft tissue findings consistent with NSTI (erythema, crepitus, or pain out of proportion to exam), AND; Systemic signs of infection including fever (temperature >38.0°C) or leukocytosis (≥11,000 peripheral white cells per cubic millimeter), AND; Patients who undergo excisional debridement and/or amputation to achieve source control.
You can't join if
- Pregnant patients
- Prisoners
- Patients with bacteremia upon admission
- Patients unable to provide consent (including no legally authorized representative)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of California Irvine Medical Center
Orange, California, United States
- Areg Grigorian, MD · Contact8184389093agrigori@hs.uci.edu
- Jeffry Nahmias, MD · Contact9493073035jnahmias@hs.uci.edu
- Areg Grigorian, MD · Principal investigator
- Jeffry Nahmias, MD · Sub-investigator
- Sebastian Schubl, MD · Sub-investigator
- Lanny L Hsieh, MD · Sub-investigator
- Steven E Atallah, PharmD · Sub-investigator
- Claudia A Alvarez, MD · Sub-investigator
- Negaar Aryan, MD · Sub-investigator
Recruiting
Study team
Sponsor
University of California, Irvine
Study ID 2826
Principal investigator
Areg Grigorian, MD
University of California, Irvine
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.