Comparing short and long antibiotic courses for severe skin infections
Official title: Pilot Randomized Controlled Trial of Shorter Versus Extended Course of Antibiotic Therapy for Necrotizing Soft Tissue Infections
Run by University of California, Irvine · NCT06002607 · Data updated 2026-11-12
This study is testing whether a shorter 48-hour course of antibiotics is just as safe and effective as a longer 7-day course for patients with severe skin infections.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | University of California, Irvine Academic / other |
| Locations | 1 site (Orange, California) |
| Status | Recruiting |
| Started | December 28, 2023 |
| Main results expected | December 1, 2026 |
| Study ends | December 1, 2026 |
| Registry record updated | February 10, 2026 |
| Trial ID | NCT06002607 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults 18 years and older presenting with symptoms of NSTI who require surgical intervention for source control.
✕Probably not a fit
Patients who are pregnant, prisoners, or unable to provide consent will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the safety of a shorter course of antibiotics (48 hours) compared to a longer course (7 days) for patients with necrotizing soft tissue infections (NSTI) after achieving source control. It aims to determine if the shorter duration has similar risks of morbidity and mortality as the longer course. The study also seeks to correlate serum procalcitonin levels with the resolution of systemic infection in these patients. By potentially reducing antibiotic use, the study may help mitigate costs and adverse effects associated with prolonged antibiotic therapy.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective antibiotic treatment protocols for patients with necrotizing soft tissue infections.
How similar studies have gone: Previous studies have shown promising results with shorter antibiotic durations in surgical infections, suggesting potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Pregnant patients * Prisoners * Patients with bacteremia upon admission * Patients unable to provide consent (including no legally authorized representative)
Where it's running
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University of California Irvine Medical Center
Orange, California, United States Recruiting
Study contacts
- Principal investigator: Areg Grigorian, MD — University of California, Irvine
- Study coordinator: Areg Grigorian, MD
- Email: agrigori@hs.uci.edu
- Phone: 8184389093
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Adding hyperbaric oxygen therapy to standard care for necrotizing soft-tissue infection
This trial will test if giving hyperbaric oxygen therapy in addition to surgery, antibiotics, and intensive care helps adults with confirmed necrotizing soft-tissue infection survive the first 30 days.
-
Managing necrotizing soft tissue infections with specialized wound matrices
This study is testing if special wound dressings can help people with severe skin infections heal better than regular dressings.
-
Registry for soft tissue reconstruction using Myriad™ devices
This study is testing how safe and effective Myriad Matrix™ and Morcells™ devices are for people undergoing soft tissue reconstruction surgeries for different conditions.
-
Using blue light to improve immune response in patients with infections
This study is testing if bright blue light can help boost the immune response and improve recovery for patients with infections like pneumonia while they are in the hospital.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.