RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pilot Randomized Controlled Trial of Shorter Versus Extended Course of Antibiotic Therapy for Necrotizing Soft Tissue Infections

Quick Facts

Study Start:2023-12-28
Study Completion:2025-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06002607

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult patients 18 years of age or older with all following criteria:
  2. * Presenting to the Emergency Department with history, exam and/or imaging concerning NSTI, AND
  3. * Patients who undergo consultation by the Emergency General Surgery service, AND
  4. * Patients included must have skin or soft tissue findings consistent with NSTI (erythema, crepitus, or pain out of proportion to exam), AND
  5. * Systemic signs of infection including fever (temperature \>38.0°C) or leukocytosis (≥11,000 peripheral white cells per cubic millimeter), AND
  6. * Patients who undergo excisional debridement and/or amputation to achieve source control.
  1. * Pregnant patients
  2. * Prisoners
  3. * Patients with bacteremia upon admission
  4. * Patients unable to provide consent (including no legally authorized representative)

Contacts and Locations

Study Contact

Areg Grigorian, MD
CONTACT
8184389093
agrigori@hs.uci.edu
Jeffry Nahmias, MD
CONTACT
9493073035
jnahmias@hs.uci.edu

Principal Investigator

Areg Grigorian, MD
PRINCIPAL_INVESTIGATOR
University of California, Irvine

Study Locations (Sites)

University of California Irvine Medical Center
Orange, California, 92868
United States

Collaborators and Investigators

Sponsor: University of California, Irvine

  • Areg Grigorian, MD, PRINCIPAL_INVESTIGATOR, University of California, Irvine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-28
Study Completion Date2025-09-01

Study Record Updates

Study Start Date2023-12-28
Study Completion Date2025-09-01

Terms related to this study

Additional Relevant MeSH Terms

  • Necrotizing Soft Tissue Infection