Shorter Versus Extended Course of Antibiotic Therapy for Necrotizing Soft Tissue Infections
Recruiting now
Conditions studied: Necrotizing Soft Tissue Infection
In brief
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.
Key facts
- Study ID
- NCT06002607
- Run by
- University of California, Irvine
- People needed
- 50
- Starts
- 2023-12-28
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-02-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You 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 may not qualify if…
- Pregnant patients
- Prisoners
- Patients with bacteremia upon admission
- Patients unable to provide consent (including no legally authorized representative)
Where it is running
- University of California Irvine Medical Center — Orange, California, United States (enrolling)
Full record on ClinicalTrials.gov
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