Comparing short and long antibiotic courses for severe skin infections
Pilot Randomized Controlled Trial of Shorter Versus Extended Course of Antibiotic Therapy for Necrotizing Soft Tissue Infections
University of California, Irvine · NCT06002607
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 |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, Irvine (other) |
| Locations | 1 site (Orange, California) |
| Trial ID | NCT06002607 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults 18 years and older presenting with symptoms of NSTI who require surgical intervention for source control.
Not a fit: Patients who are pregnant, prisoners, or unable to provide consent will not benefit from this study.
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 performed: Previous studies have shown promising results with shorter antibiotic durations in surgical infections, suggesting potential for success in this approach.
Eligibility criteria
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 this trial is running
Orange, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Necrotizing Soft Tissue Infection