Necrotizing soft tissue infections: APACHE II score, dissemination, and survival.
Tuncay Yilmazlar, Ersin Ozturk, Alpaslan Alsoy...
https://pubmed.ncbi.nlm.nih.gov/17610007Actively Recruiting
Age: 18Years +
All Genders
ID06002607
Pilot Randomized Controlled Trial of Shorter Versus Extended Course of Antibiotic Therapy for Necrotizing Soft Tissue Infections
Led by University of California, Irvine · Updated on 2026-02-10
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Necrotizing soft tissue infection (NSTI) is a serious condition with high in-hospital complications and nearly a 30% mortality rate despite advances in treatment. Researchers are studying whether a shorter course of antibiotics, given for 48 hours after infection source control, is as safe as a longer 7-day course. The study also aims to see if blood levels of procalcitonin can indicate when the infection has resolved. Participants receive either a 48-hour or 7-day antibiotic treatment using drugs like Clindamycin, Vancomycin, or Piperacillin-Tazobactam, given alone or combined based on patient needs. The choice of antibiotic is made by the attending surgeon. This pilot study compares outcomes between these two treatment durations after surgical source control of the infection. During the study, participants will have blood samples taken daily for up to 7 days to measure procalcitonin and other markers. Researchers will track safety by monitoring mortality, hospital length of stay, complications such as return to surgery, ventilator days, and antibiotic-related issues. The study continues for about one year to assess these outcomes thoroughly.
CONDITIONS
Brief Title
Shorter Versus Extended Course of Antibiotic Therapy for Necrotizing Soft Tissue Infections
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adult patients 18 years of age or older
- Presenting to the Emergency Department with history, exam and/or imaging concerning NSTI
- Undergo consultation by the Emergency General Surgery service
- Have skin or soft tissue findings consistent with NSTI (erythema, crepitus, or pain out of proportion to exam)
- Show systemic signs of infection including fever (>38.0°C) or leukocytosis (≥11,000 peripheral white cells per cubic millimeter)
- Undergo excisional debridement and/or amputation to achieve source control
You will not qualify if you...
- Pregnant patients
- Prisoners
- Patients with bacteremia upon admission
- Patients unable to provide consent (including no legally authorized representative)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - 48 hours to 7 days after source control
Participants receive either a shorter 48-hour course or an extended 7-day course of antibiotics after source control for necrotizing soft tissue infections. The specific antibiotics used are determined by the attending surgeon as part of standard care.
Antibiotics administered according to clinical care; blood samples for procalcitonin taken daily for up to 7 days
Long-term Monitoring
Duration - Up to 1 year after treatment
Participants are monitored for safety outcomes including mortality, complications, and hospital length of stay for up to 1 year after treatment.
Trial Site Locations
Total: 1 location
1
University of California Irvine Medical Center
Orange, California, United States, 92868
Actively Recruiting
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Research Team
A
Areg Grigorian, MD
J
Jeffry Nahmias, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Ben J Childers, Louis D Potyondy, Ryan Nachreiner...
https://pubmed.ncbi.nlm.nih.gov/11842952Necrotizing fasciitis: a challenging diagnosis.
Ashraf F Hefny, Hani O Eid, Mudher Al-Hussona...
https://pubmed.ncbi.nlm.nih.gov/17198329Practice guidelines for the diagnosis and management of skin and soft tissue infections: 2014 update by the Infectious Diseases Society of America.
Dennis L Stevens, Alan L Bisno, Henry F Chambers...
https://pubmed.ncbi.nlm.nih.gov/24973422Procalcitonin for diagnosis of infection and guide to antibiotic decisions: past, present and future.
Philipp Schuetz, Werner Albrich, Beat Mueller
https://pubmed.ncbi.nlm.nih.gov/21936959Clinical review 167: Procalcitonin and the calcitonin gene family of peptides in inflammation, infection, and sepsis: a journey from calcitonin back to its precursors.
K L Becker, E S Nylén, J C White...
https://pubmed.ncbi.nlm.nih.gov/15070906A Multi-Center Review of Care Patterns and Outcomes in Necrotizing Soft Tissue Infections.
Iris Faraklas, Derek Yang, Michael Eggerstedt...
https://pubmed.ncbi.nlm.nih.gov/27834617Duration of Antibiotic Therapy in Necrotizing Soft Tissue Infections: Shorter is Safe.
W T Hillman Terzian, Andrew M Nunn, Erika B Call...
https://pubmed.ncbi.nlm.nih.gov/35451883Estimating the Impact of Necrotizing Soft Tissue Infections in the United States: Incidence and Re-Admissions.
Addison K May, Victor B Talisa, David A Wilfret...
https://pubmed.ncbi.nlm.nih.gov/32833599