Necrotizing Soft Tissue InfectionPhase 4HOT-NSTINCT07489274
Adjunctive Hyperbaric Oxygen Treatment for Patients With Necrotizing Soft-Tissue Infection (HOT-NSTI Trial).
A Phase 4 study testing Hyperbaric oxygen treatment in people with Necrotizing Soft Tissue Infection, run by Ole Hyldegaard at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Necrotizing Soft Tissue Infection
- What is being tested?
- Hyperbaric oxygen treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,480 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 4 Apr 2026to 30 Jun 2033
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Belgium1 site, 1 recruiting
- Recruiting
University Hospital Antwerpen
Antwerp, Edegem, 2650
Symen Ligthart, MD, PhD, +32 489521716, symen.ligthart@uza.be
Norway1 site, 1 recruiting
- Recruiting
Haukeland University Hospital
Bergen
Torbjørn Nedrebø, MD, +47 48058481, torbjorn.nedrebo@helse-bergen.no
About this study
Official title: Adjunctive Hyperbaric Oxygen Treatment for Patients With Necrotizing Soft-Tissue Infection (HOT-NSTI Trial)
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.
- Conditions
- Necrotizing Soft Tissue Infection
- Being tested
- Hyperbaric oxygen treatment, Standard of Care (Investigator Choice)
- Keywords
- NSTI, Sepsis, clinical trial, Hyperbaric Oxygen Treatment, Hyperbaric Oxygen Therapy, Necrotizing soft tissue infection
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric oxygen treatmentDrug
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 be performed within 48 hours after randomization. If the patient is considered clinical unstable after the initial three sessions (e.g. ongoing progression of the necrotising process or requiring intravenous blood pressure support in a dosage considered not related to sedation agents) additional sessions must be administered at a rate of one per approximately 24 hours, up to a maximum of five treatments. All sessions must be completed within a total timeframe of 96 hours from randomization.
Standard of Care (Investigator Choice)Other
Standard of care (e.g. intensive care, surgery, antibiotics)
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Active comparator | standard of care (e.g. intensive care, surgery, antibiotics) Receives: Other: Standard of Care (Investigator Choice) |
| Standard of care + hyperbaric oxygen treatment | Experimental | standard of care (e.g. intensive care, surgery, antibiotics) + hyperbaric oxygen treatment Receives: Drug: Hyperbaric oxygen treatment; Other: Standard of Care (Investigator Choice) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
30-day all-cause mortality post-randomization
Measured: 30-day post-randomization
Secondary outcomes (2)
Mortality
90-day all-cause mortality post-randomization
Measured: 90-day post-randomization
Amputations
Amputation (y/n) within 7 days post-randomization
Measured: 7 days post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start4 Apr 2026
- Primary completion30 Apr 2033 (estimated)
- Study completion30 Jun 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotizing Soft Tissue InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Investigator-initiated, international, multicentre, superiority, randomized, open-label, clinical trial
- Masking
- None (open label)
- Enrolment
- 1,480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ole Hyldegaard
- Sponsor type
- University, hospital or other
- Collaborators
- Københavns Universitet, AZ Sint-Lucas Brugge, Ziekenhuis Oost-Limburg, University Hospital, Antwerp, Copenhagen University Hospital, Rigshospitalet, Oslo University Hospital, Haukeland University Hospital, Turku University Hospital, Karolinska University Hospital
- Responsible party
- Sponsor-investigator, Ole Hyldegaard, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489274
- Sponsor's protocol ID
- 2025-521368-37-00
- Other IDs
- 2025-521368-37-00, 2025
- Acronym
- HOT-NSTI
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Hyperbaric Oxygen Treatment for Patients With Necrotizing Soft-Tissue Infection (HOT-NSTI Trial)
- ClinicalTrials.gov ID
- NCT07489274
- Acronym / sponsor ID
- HOT-NSTI / 2025-521368-37-00
- Conditions
- Necrotizing Soft Tissue Infection
- Keywords
- NSTI, Sepsis, clinical trial, Hyperbaric Oxygen Treatment, Hyperbaric Oxygen Therapy, Necrotizing soft tissue infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,480 participants (estimated)
- Lead sponsor
- Ole HyldegaardUniversity, hospital or other
- Collaborators
- Københavns Universitet, AZ Sint-Lucas Brugge, Ziekenhuis Oost-Limburg, University Hospital, Antwerp, Copenhagen University Hospital, Rigshospitalet, Oslo University Hospital, Haukeland University Hospital, Turku University Hospital, Karolinska University Hospital
- Study start
- 4 Apr 2026 (actual)
- Primary completion
- 30 Apr 2033 (estimated)
- Study completion
- 30 Jun 2033 (estimated)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Investigator-initiated, international, multicentre, superiority, randomized, open-label, clinical trial
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Active comparator | Other: Standard of Care (Investigator Choice)standard of care (e.g. intensive care, surgery, antibiotics) |
| Standard of care + hyperbaric oxygen treatment | Experimental | Drug: Hyperbaric oxygen treatment, Other: Standard of Care (Investigator Choice)standard of care (e.g. intensive care, surgery, antibiotics) + hyperbaric oxygen treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric oxygen treatmentPatients 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 be performed within 48 hours after randomization. If the patient is considered clinical unstable after the initial three sessions (e.g. ongoing progression of the necrotising process or requiring intravenous blood pressure support in a dosage considered not related to sedation agents) additional sessions must be administered at a rate of one per approximately 24 hours, up to a maximum of five treatments. All sessions must be completed within a total timeframe of 96 hours from randomization. | Drug | Standard of care + hyperbaric oxygen treatment |
| Standard of Care (Investigator Choice)Standard of care (e.g. intensive care, surgery, antibiotics) | Other | Standard of care, Standard of care + hyperbaric oxygen treatment |
Primary outcome
Mortality
Time frame: 30-day post-randomization
30-day all-cause mortality post-randomization
2 secondary outcomes
Mortality
Time frame: 90-day post-randomization
Amputations
Time frame: 7 days post-randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Official trial websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hyperbaric oxygen treatment in people with Necrotizing Soft Tissue Infection, run by Ole Hyldegaard at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 30-day post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.