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

Part of paid clinical trials in Orange, California.

Sponsor
University of California, Irvine
Study ID
NCT06002607
Status
Recruiting
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Conditions

  • Necrotizing Soft Tissue Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Antibiotic duration (short course) — OTHER
    The patient will be enrolled in a 48-hour course of antibiotics.
  • Antibiotic duration (extended course) — OTHER
    The patient will be enrolled in a 7 day course of antibiotics.

Study Details

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.

Key Dates

Start date
Dec 28, 2023
Status verified
Feb 2026
Primary completion
Dec 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Short course of antibiotics
    Patients assigned to a 48-hour course of antibiotics. As the current standard of care, the antibiotics used in this treatment are Clindamycin, Vancomycin, Piperacillin-Tazobactam; these antibiotics may be administered combined or individually, based on individualized patient treatment. The specific choice of antibiotic therapy will not be dictated by the study protocol but by the attending surgeon taking care of the patient
  • Arm: Long course of antibiotics
    Patients assigned to a 7 day course of antibiotics. As the current standard of care, the antibiotics used in this treatment are Clindamycin, Vancomycin, Piperacillin-Tazobactam; these antibiotics may be administered combined or individually, based on individualized patient treatment. The specific choice of antibiotic therapy will not be dictated by the study protocol but by the attending surgeon taking care of the patient

Primary Outcome Measure

Safety of the antibiotic course duration [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California Irvine Medical CenterOrangeCalifornia92868
Areg Grigorian, MD
[email protected]
8184389093
Jeffry Nahmias, MD
[email protected]
9493073035
Areg Grigorian, MD (PRINCIPAL_INVESTIGATOR)
Jeffry Nahmias, MD (SUB_INVESTIGATOR)
Sebastian Schubl, MD (SUB_INVESTIGATOR)
Lanny L Hsieh, MD (SUB_INVESTIGATOR)
Steven E Atallah, PharmD (SUB_INVESTIGATOR)
Claudia A Alvarez, MD (SUB_INVESTIGATOR)
Negaar Aryan, MD (SUB_INVESTIGATOR)

Find similar trials in Orange, CA

By research site
University of California Irvine Medical Center· Orange, CA

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