Status:
RECRUITING
Real-Time Diagnosis of Life-Threatening Necrotizing Soft Tissue Infections (NSTI) Using Indocyanine Green (ICG) Kinetic Modeling
Lead Sponsor:
Eric R. Henderson
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Necrotizing Fascitis
Eligibility:
All Genders
18+ years
Brief Summary
Necrotizing soft-tissue infections (NSTIs, a.k.a. "necrotizing fasciitis" or "flesh-eating bacteria") are aggressive infections that can progress rapidly from mild symptoms to sepsis, multi-organ fail...
Eligibility Criteria
Inclusion
- Age ≥18 years.
- Clinical suspicion of NSTI based on the local standard of care warranting:
- Hospital admission for observation due to suspected NSTI; and/or
- Soft tissue biopsy to rule in/out suspected NSTI; and/or
- Surgical debridement for suspected NSTI; and/or
- Specific institutional threshold criteria for triggering NSTI work-up; and
- Ability to give written informed consent.
Exclusion
- History of allergy to ICG and/or iodine.
- Pregnant women or nursing mothers.
Key Trial Info
Start Date :
September 26 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2030
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT06877793
Start Date
September 26 2025
End Date
July 1 2030
Last Update
January 5 2026
Active Locations (8)
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1
University of California, Los Angeles
Los Angeles, California, United States, 90095
2
Stanford University
Stanford, California, United States, 94305
3
Emory University/Grady Memorial Hospital
Atlanta, Georgia, United States, 30322
4
University of Michigan
Ann Arbor, Michigan, United States, 48104