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

NCT06002607 | Recruiting

• 1 other identifier: 2826
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Necrotizing Soft Tissue Infection

Outcome Measures

Primary Outcomes (2)

• Safety of the antibiotic course duration

  In-hospital complications

  Through study completion, an average of 1 year

• Mortality rate

  In-hospital mortality

  Through study completion, an average of 1 year

Secondary Outcomes (21)

• Age

  Baseline, pre-intervention/procedure/surgery

• Sex

  Baseline, pre-intervention/procedure/surgery

• BMI (body mass index)

  Baseline, pre-intervention/procedure/surgery

• Blood Pressure

  Baseline, pre-intervention/procedure/surgery

• Heart Rate

  Baseline, pre-intervention/procedure/surgery

Study Arms (2)

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

Other: Antibiotic duration (short course)

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

Other: Antibiotic duration (extended course)

Interventions

Antibiotic duration (short course) OTHER

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

Short course of antibiotics

Antibiotic duration (extended course) OTHER

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

Long course of antibiotics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with a diagnosis of Necortizing Soft Tissue Infection who undergo consultation by the Emergency General Surgery service.

You may qualify if:

• Adult patients 18 years of age or older with all following criteria:
• 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
• Patients who undergo excisional debridement and/or amputation to achieve source control.

You may not qualify if:

• Pregnant patients
• Prisoners
• Patients with bacteremia upon admission
• Patients unable to provide consent (including no legally authorized representative)

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California Irvine Medical Center

Orange, California, 92868, United States

RECRUITING

Related Publications (9)

• Yilmazlar T, Ozturk E, Alsoy A, Ozguc H. Necrotizing soft tissue infections: APACHE II score, dissemination, and survival. World J Surg. 2007 Sep;31(9):1858-1862. doi: 10.1007/s00268-007-9132-1.

  PMID: 17610007 BACKGROUND

• Childers BJ, Potyondy LD, Nachreiner R, Rogers FR, Childers ER, Oberg KC, Hendricks DL, Hardesty RA. Necrotizing fasciitis: a fourteen-year retrospective study of 163 consecutive patients. Am Surg. 2002 Feb;68(2):109-16.

  PMID: 11842952 BACKGROUND

• Hefny AF, Eid HO, Al-Hussona M, Idris KM, Abu-Zidan FM. Necrotizing fasciitis: a challenging diagnosis. Eur J Emerg Med. 2007 Feb;14(1):50-2. doi: 10.1097/01.mej.0000228447.48276.7b.

  PMID: 17198329 BACKGROUND

• Stevens DL, Bisno AL, Chambers HF, Dellinger EP, Goldstein EJ, Gorbach SL, Hirschmann JV, Kaplan SL, Montoya JG, Wade JC; Infectious Diseases Society of America. Practice guidelines for the diagnosis and management of skin and soft tissue infections: 2014 update by the Infectious Diseases Society of America. Clin Infect Dis. 2014 Jul 15;59(2):e10-52. doi: 10.1093/cid/ciu444.

  PMID: 24973422 BACKGROUND

• Schuetz P, Albrich W, Mueller B. Procalcitonin for diagnosis of infection and guide to antibiotic decisions: past, present and future. BMC Med. 2011 Sep 22;9:107. doi: 10.1186/1741-7015-9-107.

  PMID: 21936959 BACKGROUND

• Becker KL, Nylen ES, White JC, Muller B, Snider RH Jr. Clinical review 167: Procalcitonin and the calcitonin gene family of peptides in inflammation, infection, and sepsis: a journey from calcitonin back to its precursors. J Clin Endocrinol Metab. 2004 Apr;89(4):1512-25. doi: 10.1210/jc.2002-021444. No abstract available.

  PMID: 15070906 BACKGROUND

• Faraklas I, Yang D, Eggerstedt M, Zhai Y, Liebel P, Graves G, Dissanaike S, Mosier M, Cochran A. A Multi-Center Review of Care Patterns and Outcomes in Necrotizing Soft Tissue Infections. Surg Infect (Larchmt). 2016 Dec;17(6):773-778. doi: 10.1089/sur.2015.238. Epub 2016 Nov 11.

  PMID: 27834617 BACKGROUND

• Terzian WTH, Nunn AM, Call EB, Bliss SE, Swinarska JT, Rigdon J, Avery MD, Hoth JJ, Miller PR 3rd. Duration of Antibiotic Therapy in Necrotizing Soft Tissue Infections: Shorter is Safe. Surg Infect (Larchmt). 2022 Jun;23(5):430-435. doi: 10.1089/sur.2022.011. Epub 2022 Apr 22.

  PMID: 35451883 BACKGROUND

• May AK, Talisa VB, Wilfret DA, Bulger E, Dankner W, Bernard A, Yende S. Estimating the Impact of Necrotizing Soft Tissue Infections in the United States: Incidence and Re-Admissions. Surg Infect (Larchmt). 2021 Jun;22(5):509-515. doi: 10.1089/sur.2020.099. Epub 2020 Aug 21.

  PMID: 32833599 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biochemical procalcitonin on admission and daily for up to 7 days or after source control has been achieved.

Study Officials

• Areg Grigorian, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Areg Grigorian, MD

CONTACT

8184389093; agrigori@hs.uci.edu

Jeffry Nahmias, MD

CONTACT

9493073035; jnahmias@hs.uci.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor, Surgery

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: August 21, 2023
• Study Start: December 28, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)