HOT-NSTI
Adjunctive Hyperbaric Oxygen Treatment for Patients with Necrotizing Soft Tissue Infection
Necrotizing soft-tissue infection (NSTI) is a rare, severe, fast-progressing bacterial infection within the soft tissue compartment. The NSTI mortality rate remain high and largely unaltered in the last decades. The standard of care in NSTI is multidisciplinary and includes surgery, intensive care, and broad-spectrum antibiotics. Hyperbaric oxygen (HBO2) treatment is an adjunctive treatment potentially improving survival, but is not standard of care in many centres, presumably as no evidence of its benefit from randomized clinical trial exists.
The primary objective of this trial, HOT-NSTI, is to investigate the effect of adjunctive HBO2 treatment on 30-day all-cause mortality in patients with NSTI.
Trial Overview
DESIGN
An investigator-initiated, international, multicenter, randomized, open-label, superiority clinical trial
TREATMENT ARMS
Standard-Of-Care Vs. Standard-Of-Care + Hyperbaric Oxygen Treatment
Primary OUTCOME
30-day all-cause mortality
Trial STATUS
The steering committee of the HOT-NSTI trial has in 2024/2025 carefully designed and prepared the study. In 2025, the trial obtained ethical approval in Europe as an emergency trial. In April 2026, the first patient enrolled into the trial.
Patients to be included:
A cohort of 1,480 adult patients with surgically confirmed NSTI
EXPected number of trial sites:
Approximately 15 centers across Europe, Australia, and North America
INTERIM ANALYSES:
Two planned interim analyses will be conducted after 50% and 75% of the patients have been enrolled.