Real-Time Diagnosis of Life-Threatening Necrotizing Soft Tissue Infections (NSTI) Using Indocyanine Green (ICG) Kinetic Modeling

RecruitingOBSERVATIONAL
Enrollment

420

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

June 30, 2030

Study Completion Date

July 31, 2030

Conditions
Necrotizing Fascitis
Interventions
DIAGNOSTIC_TEST

Administration of indocyanine green (ICG) and fluorescence imaging

Patients with clinical and lab findings consistent with a diagnosis of NSTI who consent to this study will receive a one-time, weight-appropriate dose of ICG (0.2 mg/kg, in accordance with FDA-approved recommendations). Each patient will undergo fluorescence imaging immediately before and after administration of ICG.

Trial Locations (8)

15213

NOT_YET_RECRUITING

University of Pittsburgh Medical Center, Pittsburgh

19104

NOT_YET_RECRUITING

University of Pennsylvania, Philadelphia

30322

NOT_YET_RECRUITING

Emory University/Grady Memorial Hospital, Atlanta

37235

NOT_YET_RECRUITING

Vanderbilt University, Nashville

48104

NOT_YET_RECRUITING

University of Michigan, Ann Arbor

90095

NOT_YET_RECRUITING

University of California, Los Angeles, Los Angeles

94305

NOT_YET_RECRUITING

Stanford University, Stanford

03756

RECRUITING

Dartmouth-Hitchcock Medical Center, Lebanon

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

lead

Eric R. Henderson

OTHER

NCT06877793 - Real-Time Diagnosis of Life-Threatening Necrotizing Soft Tissue Infections (NSTI) Using Indocyanine Green (ICG) Kinetic Modeling | Biotech Hunter | Biotech Hunter