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Clinical Trial NCT07489274 (HOT-NSTI) for Necrotizing Soft Tissue Infection is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Adjunctive Hyperbaric Oxygen Treatment for Patients With Necrotizing Soft-Tissue Infection (HOT-NSTI Trial). Investigator-initiated, International, Multicentre, Superiority, Randomized, Open-label, Clinical Trial. Phase 4 1,480 Randomized International Open-Label Investigator-Initiated
Clinical Trial NCT07489274 (HOT-NSTI) is designed to study Treatment for Necrotizing Soft Tissue Infection. This Phase 4 interventional study is not yet recruiting. Enrollment is planned to begin on 1 April 2027 until the study accrues 1,480 participants. Led by Ole Hyldegaard, this study is expected to complete by 30 June 2033. The latest data from ClinicalTrials.gov was last updated on 24 March 2026.
Brief Summary
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 surv...Show More
Official Title
Adjunctive Hyperbaric Oxygen Treatment for Patients With Necrotizing Soft-Tissue Infection (HOT-NSTI Trial)
Conditions
Necrotizing Soft Tissue InfectionOther Study IDs
- HOT-NSTI
- 2025-521368-37-00
- 2025-521368-37-00 (EU Study (CTIS) Number)
NCT ID Number
Start Date (Actual)
2027-04-01
Last Update Posted
2026-03-24
Completion Date (Estimated)
2033-06-30
Enrollment (Estimated)
1,480
Study Type
Interventional
PHASE
Phase 4
Status
Not yet recruiting
Keywords
NSTI
Sepsis
clinical trial
Hyperbaric Oxygen Treatment
Hyperbaric Oxygen Therapy
Necrotizing soft tissue infection
Sepsis
clinical trial
Hyperbaric Oxygen Treatment
Hyperbaric Oxygen Therapy
Necrotizing soft tissue infection
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorStandard of care standard of care (e.g. intensive care, surgery, antibiotics) | Standard of Care (Investigator Choice) Standard of care (e.g. intensive care, surgery, antibiotics) |
ExperimentalStandard of care + hyperbaric oxygen treatment standard of care (e.g. intensive care, surgery, antibiotics) + hyperbaric oxygen treatment | Hyperbaric Oxygen Treatment Patients will be randomized to either standard of care or standard of care + adjunctive sessions of HBO2 treatment consisting of 60-90 minutes (according to local protocols) 2.8ATA (284 kPa (≈18 m' seawater equivalent)) 100% oxygen breathing. The first session will be performed as soon as possible after randomization at the trial site, and at least within 12 hours from randomization.
A minimum of three sessions will...Show More Standard of Care (Investigator Choice) Standard of care (e.g. intensive care, surgery, antibiotics) |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Mortality | 30-day all-cause mortality post-randomization | 30-day post-randomization |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Mortality | 90-day all-cause mortality post-randomization | 90-day post-randomization |
Amputations | Amputation (y/n) within 7 days post-randomization | 7 days post-randomization |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- Adults (age ≥18 years)
- Surgical confirmed NSTI (defined by perioperative tissue characteristics observed by the surgeon. The diagnosis is based on sign as necrotic or deliquescent soft tissue with widespread undermining of the surrounding tissue)
- Contraindications for HBO2 treatment according to local protocol (e.g., undrained pneumothorax)
- Confirmed pregnancy
- Referred to palliative care
- Previously randomized into the HOT-NSTI trial
- Known objection by the patient to participate in the trial
- Allergy against study drug
Ole Hyldegaard- 🎓Københavns...
Study Responsible Party
Ole Hyldegaard, Sponsor-Investigator, Professor, MD, Ph.D., DMSci, Rigshospitalet, Denmark
No contact data.