Actively Recruiting
Real-Time Diagnosis of Life-Threatening Necrotizing Soft Tissue Infections Using Indocyanine Green Kinetic Modeling
Led by Eric R. Henderson · Updated on 2026-03-19
420
Participants Needed
8
Research Sites
4 weeks
Total Duration
On this page
Sponsors
E
Eric R. Henderson
Lead Sponsor
N
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Necrotizing soft-tissue infections (NSTIs), also known as necrotizing fasciitis or flesh-eating bacteria, are severe infections that can quickly worsen from mild symptoms to life-threatening conditions like sepsis and organ failure. Diagnosing NSTIs is challenging due to non-specific signs and standard methods often miss or delay detection, contributing to a high mortality rate of 20-30%. This study evaluates a new imaging technique using indocyanine green (ICG), a fluorescent dye, to improve rapid and accurate identification of NSTIs in patients suspected of having this infection. Participants suspected of NSTI will receive a one-time, weight-based dose of ICG intravenously, followed by immediate fluorescence imaging of the affected tissues. This imaging captures blood flow characteristics to distinguish NSTI from less severe infections. The study is observational and conducted at multiple medical centers, using commercial fluorescence imaging equipment and standardized methods. Researchers aim to develop and compare clinical decision tools based on imaging data, electronic medical records, and lab results to enhance NSTI diagnosis. During the study, patients will undergo fluorescence imaging before and after ICG administration, with data collected on tissue blood flow and infection characteristics. Researchers will analyze imaging and medical record data to evaluate diagnostic accuracy. The primary outcome is assessing if tissue perfusion measured by ICG fluorescence reliably decreases in NSTIs compared to other infections. Secondary outcomes include examining variations in fluorescence based on bacterial species. Participation involves hospital observation, tissue biopsy or surgery as needed, and follow-up for up to about 30 days. The study plans to complete by July 2030.
CONDITIONS
Brief Title
Real-Time Diagnosis of Life-Threatening Necrotizing Soft Tissue Infections (NSTI) Using Indocyanine Green (ICG) Kinetic Modeling
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Clinical suspicion of NSTI based on local standard of care
- Hospital admission for observation due to suspected NSTI, and/or soft tissue biopsy to confirm NSTI, and/or surgical debridement for suspected NSTI
- Meeting specific institutional criteria for NSTI work-up
- Ability to provide written informed consent
You will not qualify if you...
- Allergy to indocyanine green (ICG) or iodine
- Pregnant women
- Nursing mothers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - About 1 day
Participants receive a one-time dose of indocyanine green (ICG) and undergo fluorescence imaging to assess tissue perfusion related to necrotizing soft tissue infections.
1 visit (in-person) for ICG administration and imaging
Duration - About 30 days
Participants are observed for up to 30 days to evaluate imaging and lab results related to infection characteristics.
Follow-up visits as per standard care
Trial Site Locations
Total: 8 locations
1
University of California, Los Angeles
Los Angeles, California, United States, 90095
Not Yet Recruiting
2
Stanford University
Stanford, California, United States, 94305
Actively Recruiting
3
Emory University/Grady Memorial Hospital
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
University of Michigan
Ann Arbor, Michigan, United States, 48104
Actively Recruiting
5
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
6
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
7
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Not Yet Recruiting
8
Vanderbilt University
Nashville, Tennessee, United States, 37235
Actively Recruiting
Research Team
E
Eric R Henderson, MD
M
Morgan T Mazanec, MPH
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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