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RECRUITING
NCT06002607

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

Sponsor: University of California, Irvine

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2023-12-28

Completion Date

2026-12-01

Last Updated

2026-02-10

Healthy Volunteers

No

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.

Locations (1)

University of California Irvine Medical Center

Orange, California, United States