Clinical trial Recruiting at 4 sites Observational Ages 18 and up

Factors linked to in-hospital death in necrotizing soft tissue infections

Official title: Factors Associated With In-hospital Mortality in Necrotizing Soft Tissue Infections. A Multicenter Retrospective Cohort Study. FATAL-NSTI Study (Factors Associated With In-hospital mortALity in NSTI).

Run by University of Cagliari · NCT07359651 · Data updated 2026-11-12

This project will try to identify early clinical and laboratory signs at hospital admission that predict which adults with necrotizing soft tissue infections are at highest risk of dying in hospital.

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Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment300 (estimated)
SponsorUniversity of Cagliari
Academic / other
Locations4 sites (Cagliari and 3 other locations)
StatusRecruiting
StartedJanuary 1, 2020
Main results expectedMarch 31, 2026
Study endsApril 30, 2026
Registry record updatedJanuary 22, 2026
Trial IDNCT07359651 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18 or older admitted with a confirmed necrotizing soft tissue infection (including necrotizing fasciitis or Fournier's gangrene) at one of the participating hospitals are the intended participants.

Probably not a fit

Children under 18, patients with non-necrotizing skin or soft tissue infections, patients transferred to another hospital before completion of care, and those with missing outcome data are unlikely to benefit from this analysis.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational multicenter cohort collects routine clinical and laboratory data from adults admitted with necrotizing soft tissue infections at four tertiary referral hospitals in Italy. Investigators will analyze information available at hospital admission to identify factors associated with in-hospital mortality. The cohort includes necrotizing fasciitis, Fournier's gangrene, and other NSTIs of the neck or trunk, and excludes patients transferred before outcome assessment or with missing primary outcome data. The aim is to produce practical early risk indicators that clinicians can use during initial evaluation to guide monitoring, resource allocation, and treatment intensity.

Why it matters

Potential benefit: If successful, the findings could help clinicians identify high-risk patients earlier so they can prioritize urgent surgery, intensive monitoring, and targeted resources to reduce deaths.

How similar studies have gone: Prior single-center studies and scoring tools (for example LRINEC) have reported mixed performance in predicting outcomes for NSTI, so multicenter data are needed to improve reliability.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Age 18 years or older
* Hospital admission with a diagnosis of necrotizing soft tissue infection, including: Necrotizing fasciitis, Fournier's gangrene, Necrotizing soft tissue infections involving the neck or trunk.

Exclusion Criteria:

* Age younger than 18 years
* Patients with non-necrotizing skin or soft tissue infections
* Patients transferred to another hospital before completion of treatment or outcome assessment
* Missing data for the primary outcome (in-hospital mortality)

Where it's running

  • Cagliari University Hospital "Duilio Casula".
    Cagliari, Italy
    Recruiting
  • Niguarda Hospital, Trauma team.
    Milan, Italy
    Recruiting
  • San Gerardo Hospital, Department of Surgery
    Monza, Italy
    Recruiting
  • Gemelli Hospital, Rome. Department of Surgery.
    Roma, Italy
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.