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

NCT06002607 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-02-10

No results posted yet for this study

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

Interventions

OTHER

Antibiotic duration (short course)

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

OTHER

Antibiotic duration (extended course)

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

Sponsors & Collaborators

  • University of California, Irvine

    lead OTHER

Principal Investigators

  • Areg Grigorian, MD · University of California, Irvine

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-28
Primary Completion
2026-12-01
Completion
2026-12-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06002607 on ClinicalTrials.gov