Necrotizing Soft Tissue InfectionNCT06002607
Shorter Versus Extended Course of Antibiotic Therapy for Necrotizing Soft Tissue Infections
An observational study of Necrotizing Soft Tissue Infection, run by University of California, Irvine at 1 site in United States.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Necrotizing Soft Tissue Infection
- What is being tested?
- Antibiotic duration (short course) and Antibiotic duration (extended course)
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Dec 2023to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with a diagnosis of Necortizing Soft Tissue Infection who undergo consultation by the Emergency General Surgery service.
Who may be able to join
- 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.
Who cannot join
- Pregnant patients
- Prisoners
- Patients with bacteremia upon admission
- Patients unable to provide consent (including no legally authorized representative)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California Irvine Medical Center
Orange, California, 92868
Areg Grigorian, MD, 8184389093, agrigori@hs.uci.edu
Jeffry Nahmias, MD, 9493073035, jnahmias@hs.uci.edu
About this study
Official title: Pilot Randomized Controlled Trial of Shorter Versus Extended Course of Antibiotic Therapy for Necrotizing Soft Tissue Infections
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.
Read the detailed description
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.
- Conditions
- Necrotizing Soft Tissue Infection
- Being tested
- Antibiotic duration (short course), Antibiotic duration (extended course)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Antibiotic duration (extended course) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the antibiotic course duration
In-hospital complications
Measured: Through study completion, an average of 1 year
Mortality rate
In-hospital mortality
Measured: Through study completion, an average of 1 year
Secondary outcomes (21)
Age
Age in years
Measured: Baseline, pre-intervention/procedure/surgery
Sex
Sex (male/female)
Measured: Baseline, pre-intervention/procedure/surgery
BMI (body mass index)
Body mass index (weight and height will be combined to report BMI in kg/m^2)
Measured: Baseline, pre-intervention/procedure/surgery
Blood Pressure
Blood Pressure (mmHg)
Measured: Baseline, pre-intervention/procedure/surgery
Heart Rate
Heart rate (beats/minute)
Measured: Baseline, pre-intervention/procedure/surgery
Respiratory rate
Respiratory rate (breaths/minute)
Measured: Baseline, pre-intervention/procedure/surgery
Temperature
Temperature (Fahrenheit)
Measured: Baseline, pre-intervention/procedure/surgery
Comorbidities
Comorbidities (e.g., diabetes, hypertension, cirrhosis, chronic kidney disease, etc.)
Measured: Baseline, pre-intervention/procedure/surgery
Transfusion requirements
Number of Packed Red Blood Cells transfused measured in milliliters
Measured: Baseline, pre-intervention/procedure/surgery
NSTI location
Anatomical location of soft tissue infection
Measured: Baseline, pre-intervention/procedure/surgery
Operations
Number of surgical procedures
Measured: Through study completion, an average of 1 year
Serum concentration of procalcitonin
Procalcitonin ng/mL
Measured: Upon admission and daily blood sample for 7 days
Serum concentration of white blood cell
White blood cell count cells per microliter (cells/μL)
Measured: Through study completion, an average of 1 year
Serum concentration of hemoglobin
Hemoglobin grams/deciliter
Measured: Through study completion, an average of 1 year
Serum concentration of sodium
Sodium millimoles per liter (mmol/L)
Measured: Through study completion, an average of 1 year
Serum concentration of C-reactive protein
C-reactive protein milligrams/liter
Measured: Through study completion, an average of 1 year
Serum concentration of glucose
Glucose milligrams/deciliter
Measured: Through study completion, an average of 1 year
Serum concentration of creatinine
Creatinine milligram/deciliter
Measured: Through study completion, an average of 1 year
Total hospital length of stay
Total days of hospital stay
Measured: Through study completion, an average of 1 year
Total intensive care unit (ICU)
Total days of ICU stay
Measured: Through study completion, an average of 1 year
Total ventilator days
Total days of ventilation support for the patient
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start28 Dec 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Necrotizing Soft Tissue InfectionStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Areg Grigorian, University of California, Irvine
- Investigators
- Areg Grigorian, MD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06002607
- Sponsor's protocol ID
- 2826
- Status last verified
- Feb 2026
- First submitted
- 11 Jul 2023
- Last updated
- 10 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The overall study results will be listed on Clinicaltrials.gov
Publications
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.
PubMed 17610007Childers 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.
PubMed 11842952Hefny 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.
PubMed 17198329Stevens 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.
PubMed 24973422Schuetz 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.
PubMed 21936959Becker 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.
PubMed 15070906Faraklas 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.
PubMed 27834617Terzian 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.
PubMed 35451883May 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.
PubMed 32833599
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Controlled Trial of Shorter Versus Extended Course of Antibiotic Therapy for Necrotizing Soft Tissue Infections
- ClinicalTrials.gov ID
- NCT06002607
- Acronym / sponsor ID
- 2826
- Conditions
- Necrotizing Soft Tissue Infection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 28 Dec 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short course of antibiotics | – | Other: Antibiotic duration (short course)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 |
| Long course of antibiotics | – | Other: Antibiotic duration (extended course)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with a diagnosis of Necortizing Soft Tissue Infection who undergo consultation by the Emergency General Surgery service.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Pregnant patients
- Prisoners
- Patients with bacteremia upon admission
- Patients unable to provide consent (including no legally authorized representative)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antibiotic duration (short course)The patient will be enrolled in a 48-hour course of antibiotics. | Other | Short course of antibiotics |
| Antibiotic duration (extended course)The patient will be enrolled in a 7 day course of antibiotics. | Other | Long course of antibiotics |
Primary outcome
Safety of the antibiotic course duration
Time frame: Through study completion, an average of 1 year
In-hospital complications
Mortality rate
Time frame: Through study completion, an average of 1 year
In-hospital mortality
21 secondary outcomes
Age
Time frame: Baseline, pre-intervention/procedure/surgery
Sex
Time frame: Baseline, pre-intervention/procedure/surgery
BMI (body mass index)
Time frame: Baseline, pre-intervention/procedure/surgery
Blood Pressure
Time frame: Baseline, pre-intervention/procedure/surgery
Heart Rate
Time frame: Baseline, pre-intervention/procedure/surgery
Respiratory rate
Time frame: Baseline, pre-intervention/procedure/surgery
Temperature
Time frame: Baseline, pre-intervention/procedure/surgery
Comorbidities
Time frame: Baseline, pre-intervention/procedure/surgery
Transfusion requirements
Time frame: Baseline, pre-intervention/procedure/surgery
NSTI location
Time frame: Baseline, pre-intervention/procedure/surgery
Operations
Time frame: Through study completion, an average of 1 year
Serum concentration of procalcitonin
Time frame: Upon admission and daily blood sample for 7 days
Serum concentration of white blood cell
Time frame: Through study completion, an average of 1 year
Serum concentration of hemoglobin
Time frame: Through study completion, an average of 1 year
Serum concentration of sodium
Time frame: Through study completion, an average of 1 year
Serum concentration of C-reactive protein
Time frame: Through study completion, an average of 1 year
Serum concentration of glucose
Time frame: Through study completion, an average of 1 year
Serum concentration of creatinine
Time frame: Through study completion, an average of 1 year
Total hospital length of stay
Time frame: Through study completion, an average of 1 year
Total intensive care unit (ICU)
Time frame: Through study completion, an average of 1 year
Total ventilator days
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Background: PubMed 17610007Yilmazlar 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.
- Background: PubMed 11842952Childers 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.
- Background: PubMed 17198329Hefny 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.
- Background: PubMed 24973422Stevens 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.
- Background: PubMed 21936959Schuetz 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.
- Background: PubMed 15070906Becker 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.
- Background: PubMed 27834617Faraklas 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.
- Background: PubMed 35451883Terzian 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.
- Background: PubMed 32833599May 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.
- Individual participant dataSharing planned: No. The overall study results will be listed on Clinicaltrials.gov
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Areg Grigorian, MD principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Necrotizing Soft Tissue Infection, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Areg Grigorian, MD (8184389093, agrigori@hs.uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the antibiotic course duration (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06002607, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.