Recruiting

Shorter vs. Extended

Sponsor:

UCLA

Code:

NCT06002607

Conditions

Necrotizing Soft Tissue Infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Antibiotic duration (short course)

Antibiotic duration (extended course)

Study Details

Brief summary:

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

Necrotizing Soft Tissue Infection

Study ID

NCT06002607

Start date

Dec 28, 2023

Status verified date

Feb, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Short course of antibiotics

Patients assigned to a 48-hour course of antibiotics. As the current standard of care, the antibiotics used in this treatment are Clindamycin, Vancomycin, Piperacillin-Tazobactam; these antibiotics may be administered combined or individually, based on individualized patient treatment. The specific choice of antibiotic therapy will not be dictated by the study protocol but by the attending surgeon taking care of the patient

Long course of antibiotics

Patients assigned to a 7 day course of antibiotics. As the current standard of care, the antibiotics used in this treatment are Clindamycin, Vancomycin, Piperacillin-Tazobactam; these antibiotics may be administered combined or individually, based on individualized patient treatment. The specific choice of antibiotic therapy will not be dictated by the study protocol but by the attending surgeon taking care of the patient

Interventions

Antibiotic duration (short course)

The patient will be enrolled in a 48-hour course of antibiotics.

Antibiotic duration (extended course)

The patient will be enrolled in a 7 day course of antibiotics.

Primary outcome measure

  • Safety of the antibiotic course duration [ Time Frame: Through study completion, an average of 1 year ]
  • Mortality rate [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Areg Grigorian, MD

8184389093agrigori@hs.uci.edu

Jeffry Nahmias, MD

9493073035jnahmias@hs.uci.edu

Locations

University of California Irvine Medical Center

Recruiting

Orange, California, United States, 92868

Contacts

Areg Grigorian, MD

8184389093agrigori@hs.uci.edu

Jeffry Nahmias, MD

9493073035jnahmias@hs.uci.edu

Principal Investigator:

Areg Grigorian, MD

More Information

Sponsor

University of California, Irvine

Last update posted

Feb 10, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Irvine on 2026-02-10.