Actively Recruiting

Age: 18Years +
All Genders
NCT06002607

Shorter Versus Extended Course of Antibiotic Therapy for Necrotizing Soft Tissue Infections

Led by University of California, Irvine · Updated on 2026-02-10

50

Participants Needed

1

Research Sites

152 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Shorter Versus Extended Course of Antibiotic Therapy for Necrotizing Soft Tissue Infections

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients 18 years or older
  • Presenting to the Emergency Department with signs or imaging suggesting NSTI
  • Consulted by the Emergency General Surgery service
  • Have skin or soft tissue signs consistent with NSTI such as erythema, crepitus, or severe pain
  • Show systemic infection signs including fever above 38.0°C or high white blood cell count (≥11,000/mm3)
  • Underwent excisional debridement and/or amputation for source control
Not Eligible

You will not qualify if you...

  • Pregnant patients
  • Prisoners
  • Patients with bacteremia at admission
  • Patients unable to provide consent or without a legally authorized representative

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of California Irvine Medical Center

Orange, California, United States, 92868

Actively Recruiting

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Research Team

A

Areg Grigorian, MD

CONTACT

J

Jeffry Nahmias, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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