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

Pilot Randomized Controlled Trial of Shorter Versus Extended Course of Antibiotic Therapy for Necrotizing Soft Tissue Infections

Who can join

Ages 18 and older · All sexes

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Pregnant patients
* Prisoners
* Patients with bacteremia upon admission
* Patients unable to provide consent (including no legally authorized representative)

About the study

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 is being tested

• Antibiotic duration (short course) (other)
• Antibiotic duration (extended course) (other)

Sponsor: University of California, Irvine · Participants: 50 · Started: Dec 28, 2023

Contact the study team

• Areg Grigorian, MD · Phone: 8184389093
• Jeffry Nahmias, MD · Phone: 9493073035

Official record on ClinicalTrials.gov — NCT06002607

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.