Recruiting PHASE4 Necrotizing Soft Tissue Infection

New treatment option for Necrotizing Soft Tissue Infection

Official title Adjunctive Hyperbaric Oxygen Treatment for Patients With Necrotizing Soft-Tissue Infection (HOT-NSTI Trial).

ClinicalTrials.gov ID: NCT07489274

What this study is testing

What is Hyperbaric oxygen treatment?

Hyperbaric oxygen treatment is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for necrotizing soft tissue infection.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 4: studies an already-approved treatment
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • 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...

You likely can't join if

  • Contraindications for HBO2 treatment according to local protocol (e.g., undrained pneumothorax)
  • Confirmed pregnancy
  • Referred to palliative care
  • Previously assigned by chance into the HOT-NSTI trial
  • Known objection by the patient to participate in the trial
  • Allergy against study drug

The study team makes the final eligibility decision.

Where it's taking place

  • Antwerp, Edegem, Belgium

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Antwerp, Edegem, Belgium. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.