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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of California, Irvine

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Antibiotic duration (short course)

    Other intervention

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

  • Antibiotic duration (extended course)

    Other intervention

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Short course of antibiotics1 intervention
Group B: Long course of antibiotics1 intervention

Trial outcomes

Primary outcomes

1

Safety of the antibiotic course duration

In-hospital complications

Time frame
Through study completion, an average of 1 year
2

Mortality rate

In-hospital mortality

Time frame
Through study completion, an average of 1 year

Secondary outcomes

1

Age

Age in years

Time frame
Baseline, pre-intervention/procedure/surgery
2

Sex

Sex (male/female)

Time frame
Baseline, pre-intervention/procedure/surgery
3

BMI (body mass index)

Body mass index (weight and height will be combined to report BMI in kg/m\^2)

Time frame
Baseline, pre-intervention/procedure/surgery
4

Blood Pressure

Blood Pressure (mmHg)

Time frame
Baseline, pre-intervention/procedure/surgery

Other outcomes

Sponsors and contacts

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