RecruitingNCT06002607

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


Sponsor

University of California, Irvine

Enrollment

50 participants

Start Date

Dec 28, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Antibiotic duration (extended course) and Antibiotic duration (short course) for people with necrotizing soft tissue infection. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERAntibiotic duration (short course)

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

OTHERAntibiotic 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

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NCT06002607


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