About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Pregnant patients
Prisoners
Patients with bacteremia upon admission
Patients unable to provide consent (including no legally authorized representative)
Trial population
Adult patients with a diagnosis of Necortizing Soft Tissue Infection who undergo consultation by the Emergency General Surgery service.
Trial design
Case-control
Prospective
Treatments tested in this trial
Antibiotic duration (short course)
Other interventionThe patient will be enrolled in a 48-hour course of antibiotics.
Antibiotic duration (extended course)
Other interventionThe patient will be enrolled in a 7 day course of antibiotics.
Treatment groups
Trial outcomes
Primary outcomes
Safety of the antibiotic course duration
In-hospital complications
Mortality rate
In-hospital mortality
Secondary outcomes
Age
Age in years
Sex
Sex (male/female)
BMI (body mass index)
Body mass index (weight and height will be combined to report BMI in kg/m\^2)
Blood Pressure
Blood Pressure (mmHg)
Sponsors and contacts
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