xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06002607</url>
    </required_header>
    <id_info>
      <org_study_id>2826</org_study_id>
      <nct_id>NCT06002607</nct_id>
    </id_info>
    <brief_title>Shorter Versus Extended Course of Antibiotic Therapy for Necrotizing Soft Tissue Infections</brief_title>
    <official_title>Pilot Randomized Controlled Trial of Shorter Versus Extended Course of Antibiotic Therapy for Necrotizing Soft Tissue Infections</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of California, Irvine</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of California, Irvine</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Necrotizing soft tissue infection (NSTI) is a devastating disease that results in a high rate&#xD;
        of in-hospital complications and despite advances in critical care, wound care, and early&#xD;
        intervention, NSTI continues to be associated with a mortality rate of nearly 30%. The&#xD;
        antibiotics used in this treatment are Clindamycin, Vancomycin, Piperacillin Tazobactam;&#xD;
        these antibiotics may be administered combined or individually, based on individualized&#xD;
        patient treatment. Although one of the tenets of management for NSTI is early broad-spectrum&#xD;
        intravenous antibiotics (listed above), the duration of antibiotics needed is not well&#xD;
        defined. Currently, there exists wide variation in the duration of antibiotics for NSTI&#xD;
        ranging between 2-16 days. The objective of this study is to evaluate the safety of a shorter&#xD;
        course of antibiotics hypothesizing that a short duration of antibiotics for 48-hours after&#xD;
        source-control is achieved will have similar risk of morbidity and mortality compared to a&#xD;
        7-day course of antibiotics post source control. A second aim of this study will be to&#xD;
        identify if serum procalcitonin levels/ratio correspond to resolution of systemic infection&#xD;
        in patients with NSTI.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The objective of this study is to evaluate the safety of a shorter course of antibiotics&#xD;
        hypothesizing that a short duration of antibiotics for 48-hours after source-control is&#xD;
        achieved will have similar risk of morbidity and mortality compared to a 7-day course of&#xD;
        antibiotics post source control. The proposed shortened duration is considered within&#xD;
        standard of care as the IDSA suggests 48-72 hours of antibiotics after source control,&#xD;
        however this was due mostly to expert opinion until a recent single-center study using&#xD;
        historical controls demonstrated a 48-hour duration of antibiotics to be safe. A second aim&#xD;
        of this study will be to identify if serum procalcitonin levels/ratio correspond to&#xD;
        resolution of systemic infection in patients with NSTI. This pilot study may help limit use&#xD;
        of antibiotics which are associated with both cost and significant adverse events including&#xD;
        antimicrobial resistance and clostridium difficile infections. In addition, the data would&#xD;
        support grant submission of a larger, multi-center study with sufficient power to demonstrate&#xD;
        the safety profile and potential benefits of a shorter duration of antibiotics, which has&#xD;
        been shown to be beneficial in previous large surgical infection studies.&#xD;
  &#xD;
        Specific Aims:&#xD;
  &#xD;
        Aim#1: Establish the safety of an abbreviated course (48 hours after source control) compared&#xD;
        to a prolonged (7 days after source control) course of antibiotics in terms of in-hospital&#xD;
        mortality.&#xD;
  &#xD;
        Aim#2: Compare the incidence of hospital length of stay and in-hospital complications&#xD;
        including unplanned return to the operating room, ventilator days, and antibiotic associated&#xD;
        complications (e.g., clostridium difficile infection) in the two comparison groups:&#xD;
        abbreviated (48-hours) and prolonged antibiotics (7-days) after source control.&#xD;
  &#xD;
        Aim#3: Identify a critical threshold of biochemical procalcitonin or a % decrease in&#xD;
        procalcitonin from the initial procalcitonin obtained upon admission that suggests resolution&#xD;
        of systemic infection in patients with NSTI. This will be done by obtaining a serum&#xD;
        procalcitonin upon admission and daily for up to 7 days from admission or once source control&#xD;
        has been achieved.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Safety of the antibiotic course duration</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>In-hospital complications</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Mortality rate</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>In-hospital mortality</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Age</measure>
      <time_frame>Baseline, pre-intervention/procedure/surgery</time_frame>
      <description>Age in years</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sex</measure>
      <time_frame>Baseline, pre-intervention/procedure/surgery</time_frame>
      <description>Sex (male/female)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>BMI (body mass index)</measure>
      <time_frame>Baseline, pre-intervention/procedure/surgery</time_frame>
      <description>Body mass index (weight and height will be combined to report BMI in kg/m^2)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood Pressure</measure>
      <time_frame>Baseline, pre-intervention/procedure/surgery</time_frame>
      <description>Blood Pressure (mmHg)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Heart Rate</measure>
      <time_frame>Baseline, pre-intervention/procedure/surgery</time_frame>
      <description>Heart rate (beats/minute)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Respiratory rate</measure>
      <time_frame>Baseline, pre-intervention/procedure/surgery</time_frame>
      <description>Respiratory rate (breaths/minute)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Temperature</measure>
      <time_frame>Baseline, pre-intervention/procedure/surgery</time_frame>
      <description>Temperature (Fahrenheit)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Comorbidities</measure>
      <time_frame>Baseline, pre-intervention/procedure/surgery</time_frame>
      <description>Comorbidities (e.g., diabetes, hypertension, cirrhosis, chronic kidney disease, etc.)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Transfusion requirements</measure>
      <time_frame>Baseline, pre-intervention/procedure/surgery</time_frame>
      <description>Number of Packed Red Blood Cells transfused measured in milliliters</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>NSTI location</measure>
      <time_frame>Baseline, pre-intervention/procedure/surgery</time_frame>
      <description>Anatomical location of soft tissue infection</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Operations</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>Number of surgical procedures</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serum concentration of procalcitonin</measure>
      <time_frame>Upon admission and daily blood sample for 7 days</time_frame>
      <description>Procalcitonin ng/mL</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serum concentration of white blood cell</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>White blood cell count cells per microliter (cells/μL)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serum concentration of hemoglobin</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>Hemoglobin grams/deciliter</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serum concentration of sodium</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>Sodium millimoles per liter (mmol/L)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serum concentration of C-reactive protein</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>C-reactive protein milligrams/liter</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serum concentration of glucose</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>Glucose milligrams/deciliter</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serum concentration of creatinine</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>Creatinine milligram/deciliter</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total hospital length of stay</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>Total days of hospital stay</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total intensive care unit (ICU)</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>Total days of ICU stay</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total ventilator days</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>Total days of ventilation support for the patient</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Necrotizing Soft Tissue Infection</condition>
    <arm_group>
      <arm_group_label>Short course of antibiotics</arm_group_label>
      <description>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</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Long course of antibiotics</arm_group_label>
      <description>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</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Antibiotic duration</intervention_name>
      <description>The patient will be enrolled in a 48-hour course of antibiotics.</description>
      <arm_group_label>Short course of antibiotics</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Antibiotic duration</intervention_name>
      <description>The patient will be enrolled in a 7 day course of antibiotics.</description>
      <arm_group_label>Long course of antibiotics</arm_group_label>
    </intervention>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Biochemical procalcitonin on admission and daily for up to 7 days or after source control has&#xD;
        been achieved.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Adult patients with a diagnosis of Necortizing Soft Tissue Infection who undergo&#xD;
          consultation by the Emergency General Surgery service.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult patients 18 years of age or older with all following criteria:&#xD;
  &#xD;
            -  Presenting to the Emergency Department with history, exam and/or imaging concerning&#xD;
               NSTI, AND&#xD;
  &#xD;
            -  Patients who undergo consultation by the Emergency General Surgery service, AND&#xD;
  &#xD;
            -  Patients included must have skin or soft tissue findings consistent with NSTI&#xD;
               (erythema, crepitus, or pain out of proportion to exam), AND&#xD;
  &#xD;
            -  Systemic signs of infection including fever (temperature &gt;38.0°C) or leukocytosis&#xD;
               (≥11,000 peripheral white cells per cubic millimeter), AND&#xD;
  &#xD;
            -  Patients who undergo excisional debridement and/or amputation to achieve source&#xD;
               control.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant patients&#xD;
  &#xD;
            -  Prisoners&#xD;
  &#xD;
            -  Patients with bacteremia upon admission&#xD;
  &#xD;
            -  Patients unable to provide consent (including no legally authorized representative)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Areg Grigorian, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of California, Irvine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Areg Grigorian, MD</last_name>
      <phone>8184389093</phone>
      <email>agrigori@hs.uci.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jeffry Nahmias, MD</last_name>
      <phone>9493073035</phone>
      <email>jnahmias@hs.uci.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of California Irvine Medical Center</name>
        <address>
          <city>Orange</city>
          <state>California</state>
          <zip>92868</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Areg Grigorian, MD</last_name>
        <phone>818-438-9093</phone>
        <email>agrigori@hs.uci.edu</email>
      </contact>
      <contact_backup>
        <last_name>Jeffry Nahmias, MD</last_name>
        <phone>9493073035</phone>
        <email>jnahmias@hs.uci.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Areg Grigorian, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Jeffry Nahmias, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Sebastian Schubl, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Lanny L Hsieh, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Steven E Atallah, PharmD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Claudia A Alvarez, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Negaar Aryan, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>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.</citation>
      <PMID>17610007</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>11842952</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>17198329</PMID>
    </reference>
    <reference>
      <citation>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. Erratum In: Clin Infect Dis. 2015 May 1;60(9):1448. Dosage error in article text.</citation>
      <PMID>24973422</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>21936959</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>15070906</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>27834617</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>35451883</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>32833599</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of California, Irvine</investigator_affiliation>
      <investigator_full_name>Areg Grigorian</investigator_full_name>
      <investigator_title>Assistant Clinical Professor, Surgery</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Infections</mesh_term>
      <mesh_term>Communicable Diseases</mesh_term>
      <mesh_term>Soft Tissue Infections</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Anti-Bacterial Agents</mesh_term>
      <mesh_term>Antibiotics, Antitubercular</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>The overall study results will be listed on Clinicaltrials.gov</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06002607
  org study id: 2826
  nct id: NCT06002607
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  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.
  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. The proposed shortened duration is considered within
        standard of care as the IDSA suggests 48-72 hours of antibiotics after source control,
        however this was due mostly to expert opinion until a recent single-center study using
        historical controls demonstrated a 48-hour duration of antibiotics to be safe. 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. This pilot study may help limit use
        of antibiotics which are associated with both cost and significant adverse events including
        antimicrobial resistance and clostridium difficile infections. In addition, the data would
        support grant submission of a larger, multi-center study with sufficient power to demonstrate
        the safety profile and potential benefits of a shorter duration of antibiotics, which has
        been shown to be beneficial in previous large surgical infection studies.
  
        Specific Aims:
  
        Aim#1: Establish the safety of an abbreviated course (48 hours after source control) compared
        to a prolonged (7 days after source control) course of antibiotics in terms of in-hospital
        mortality.
  
        Aim#2: Compare the incidence of hospital length of stay and in-hospital complications
        including unplanned return to the operating room, ventilator days, and antibiotic associated
        complications (e.g., clostridium difficile infection) in the two comparison groups:
        abbreviated (48-hours) and prolonged antibiotics (7-days) after source control.
  
        Aim#3: Identify a critical threshold of biochemical procalcitonin or a % decrease in
        procalcitonin from the initial procalcitonin obtained upon admission that suggests resolution
        of systemic infection in patients with NSTI. This will be done by obtaining a serum
        procalcitonin upon admission and daily for up to 7 days from admission or once source control
        has been achieved.
  observational model: Case-Control
  time perspective: Prospective
  measure: Safety of the antibiotic course duration
  time frame: Through study completion, an average of 1 year
  description: In-hospital complications
  measure: Mortality rate
  time frame: Through study completion, an average of 1 year
  description: In-hospital mortality
  measure: Age
  time frame: Baseline, pre-intervention/procedure/surgery
  description: Age in years
  measure: Sex
  time frame: Baseline, pre-intervention/procedure/surgery
  description: Sex (male/female)
  measure: BMI (body mass index)
  time frame: Baseline, pre-intervention/procedure/surgery
  description: Body mass index (weight and height will be combined to report BMI in kg/m^2)
  measure: Blood Pressure
  time frame: Baseline, pre-intervention/procedure/surgery
  description: Blood Pressure (mmHg)
  measure: Heart Rate
  time frame: Baseline, pre-intervention/procedure/surgery
  description: Heart rate (beats/minute)
  measure: Respiratory rate
  time frame: Baseline, pre-intervention/procedure/surgery
  description: Respiratory rate (breaths/minute)
  measure: Temperature
  time frame: Baseline, pre-intervention/procedure/surgery
  description: Temperature (Fahrenheit)
  measure: Comorbidities
  time frame: Baseline, pre-intervention/procedure/surgery
  description: Comorbidities (e.g., diabetes, hypertension, cirrhosis, chronic kidney disease, etc.)
  measure: Transfusion requirements
  time frame: Baseline, pre-intervention/procedure/surgery
  description: Number of Packed Red Blood Cells transfused measured in milliliters
  measure: NSTI location
  time frame: Baseline, pre-intervention/procedure/surgery
  description: Anatomical location of soft tissue infection
  measure: Operations
  time frame: Through study completion, an average of 1 year
  description: Number of surgical procedures
  measure: Serum concentration of procalcitonin
  time frame: Upon admission and daily blood sample for 7 days
  description: Procalcitonin ng/mL
  measure: Serum concentration of white blood cell
  time frame: Through study completion, an average of 1 year
  description: White blood cell count cells per microliter (cells/μL)
  measure: Serum concentration of hemoglobin
  time frame: Through study completion, an average of 1 year
  description: Hemoglobin grams/deciliter
  measure: Serum concentration of sodium
  time frame: Through study completion, an average of 1 year
  description: Sodium millimoles per liter (mmol/L)
  measure: Serum concentration of C-reactive protein
  time frame: Through study completion, an average of 1 year
  description: C-reactive protein milligrams/liter
  measure: Serum concentration of glucose
  time frame: Through study completion, an average of 1 year
  description: Glucose milligrams/deciliter
  measure: Serum concentration of creatinine
  time frame: Through study completion, an average of 1 year
  description: Creatinine milligram/deciliter
  measure: Total hospital length of stay
  time frame: Through study completion, an average of 1 year
  description: Total days of hospital stay
  measure: Total intensive care unit (ICU)
  time frame: Through study completion, an average of 1 year
  description: Total days of ICU stay
  measure: Total ventilator days
  time frame: Through study completion, an average of 1 year
  description: Total days of ventilation support for the patient
  arm group label: Short course of antibiotics
  description: 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 group label: Long course of antibiotics
  description: 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
  intervention type: Other
  intervention name: Antibiotic duration
  description: The patient will be enrolled in a 48-hour course of antibiotics.
  arm group label: Short course of antibiotics
  intervention type: Other
  intervention name: Antibiotic duration
  description: The patient will be enrolled in a 7 day course of antibiotics.
  arm group label: Long course of antibiotics
  Biochemical procalcitonin on admission and daily for up to 7 days or after source control has
        been achieved.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Areg Grigorian, MD
  role: Principal Investigator
  affiliation: University of California, Irvine
  last name: Areg Grigorian, MD
  phone: 8184389093
  email: agrigori@hs.uci.edu
  last name: Jeffry Nahmias, MD
  phone: 9493073035
  email: jnahmias@hs.uci.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: United States
  citation: 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
  citation: 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
  citation: 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
  citation: 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. Erratum In: Clin Infect Dis. 2015 May 1;60(9):1448. Dosage error in article text.
  PMID: 24973422
  citation: 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
  citation: 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
  citation: 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
  citation: 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
  citation: 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
  responsible party type: Principal Investigator
  investigator affiliation: University of California, Irvine
  investigator full name: Areg Grigorian
  investigator title: Assistant Clinical Professor, Surgery
  mesh term: Infections
  mesh term: Communicable Diseases
  mesh term: Soft Tissue Infections
  mesh term: Anti-Bacterial Agents
  mesh term: Antibiotics, Antitubercular
  sharing ipd: No
  ipd description: The overall study results will be listed on Clinicaltrials.gov