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Soft Tissue InfectionsINFECTNCT01790698

Systems Medicine to Study Necrotizing Soft Tissue Infections (NSTIs).

An observational study of Soft Tissue Infections and Necrotizing Fasciitis, run by Karolinska Institutet at 5 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This proposal focuses on highly lethal destructive tissue infections, i.e. necrotizing fasciitis and other necrotizing soft tissue infections (NSTIs), which are associated with high morbidity and mortality. Read more about this study

Who is it for?
Ages 18 years and older
How many people
409 participants
Where
5 sitesin 3 countries
Study dates
Jan 2013to Jan 2018
How long will I take part?
3 Months
Phase
Observational
Are there results?
None posted in the registry

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

Study population: Hospitalized patients with NSTI

Who may be able to join

  • Necrotizing soft tissue infections

Who cannot join

  • Patients under the age of 18 years

Trial locations and contacts

5 sites in 3 countries.

5 sites in 3 countries

Sweden3 sites

  • Sahlgrenska University Hospital

    Gothenburg, SE-416 50

  • Blekinge Hospital

    Karlskrona, SE-371 85

  • Karolinska University Hospital

    Stockholm, SE-171 76

Other trials in Sweden

Denmark1 site

  • Rigshospitalet

    Copenhagen, 2100

Other trials in Denmark

Norway1 site

  • University of Bergen

    Bergen, 5021

Other trials in Norway

About this study

Official title: Improving Outcome of Necrotizing Fasciitis: Elucidation of Complex Host and Pathogen Signatures That Dictate Severity of Tissue Infection

This proposal focuses on highly lethal destructive tissue infections, i.e. necrotizing fasciitis and other necrotizing soft tissue infections (NSTIs), which are associated with high morbidity and mortality. The fulminant course of NSTIs demands immediate diagnosis and adequate interventions in order to salvage lives and limbs. However, diagnosis and management are difficult due to heterogeneity in clinical presentation, in co-morbidities and in microbiological aetiology. Thus, there is an urgent need for novel diagnostics and therapeutics in order to improve outcome of NSTIs. A comprehensive knowledge of diagnostic features, causative microbial agent, treatment strategies, and pathogenic mechanisms (host and bacterial disease traits and their underlying interaction network) is required for an improved diagnosis and management of NSTIs. The current proposal is designed to obtain such insights through an integrated systems biology approach in patients and experimental models. The project is based on a prospective NSTI patients cohort including a clinical registry to document clinical data and treatment strategies, combined with an isolate and biobank collection. The samples will be analyzed through advanced bioinformatics and computational modelling work flow to identify and quantify pathogen signatures and underlying networks that contribute to disease outcome. One aim is to translate clinical and systems biology data into development of novel diagnostics.

Read the detailed description

Patients will be prospectively recruited at 5 clinical centers (Rigshospitalet, Karolinska University Hospital, Blekinge University, Sahlgrenska University and University of Bergen). Clinical definition criteria for NSTI: NSTI is a clinical diagnosis. Initial signs are the occurrence of erythema, pain or tenderness beyond margins of erythema and swelling. Imaging and laboratory tests have little predictive value in the early stage. The gold standard modality for diagnosis of NSTI remains operative exploration. Operative findings that are consistent with NSTI include "dishwater or foul smelling discharge, necrosis or lack of bleeding and loss of the normal resistance of the fascia to finger dissection. A patient admitted for critical care and / or surgery due to severe soft tissue infection of the fascia, muscle or subcutaneous tissues will be enrolled in this NSTI study. The patients will be stratified based on several clinical parameters including among others SAPS score, presence of multiorgan failure, and hypotensive shock. This stratification serves to classify the patients in defined severity classes to be used in analyses and modeling. Detailed demographic and clinical information will be documented in the interactive database including: age, gender, medical history, clinical presentation (shock, multiorgan failure etc), treatment and outcome. Disease progress: The clinical database is to contain information on the spread of the infection at the different times of inspection/surgical intervention. Severity of the infections will be documented by use of the updated CREST classification scheme, SAPS III score, and the LRINEC score. Detailed information regarding antimicrobial therapy, surgical intervention, innovative therapy (IVIG and HBO) will be documented.

Samples will be collected from all enrolled patients. Standard operating procedures will be generated and implemented at all sites to ensure a quality assured collection and handling of samples. Samples to be collected include (a) isolates, (b) blood samples to be processed for DNA, RNA and plasma/cells and (c) tissue biopsies in all patients whenever surgical interventions are indicated. The samples will be analyzed using genomics, transcriptomics, metabolomics and proteomics.

Keywords
Necrotizing fasciitis, Streptococcus pyogenes, Staphylococcus aureus, Immunopathogenesis
Medical subject headings
Soft Tissue Infections, Fasciitis, Necrotizing, Staphylococcal Infections

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prognostic/diagnostic value (ROC curves: specificity, sensitivity, predictive values) of classification and severity scores in NSTIs

    Measured: 3 months - further oservation up to 24 month may apply

Secondary outcomes (2)

  1. Effect of IVIG and HBO-therapy on mortality rates in matched (defined by severity scores and aetiology) NSTI patients

    Measured: 3 months - further observation up to 24 month may apply

  2. Presence of hypotension, multiorgan failure, or fatal outcome of NSTI in relation to microbiologic aetiology

    Measured: 3 months - further observation up to 60 month may apply

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2013 (estimated)
  2. Study startJan 2013
  3. Primary completionJun 2017
  4. Study completionJan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
409 participants (actual)
Target duration
3 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT01790698
Sponsor's protocol ID
INFECT-FP7305340
Acronym
INFECT
Status last verified
Apr 2018
First submitted
4 Feb 2013
Last updated
23 Apr 2018
Results posted
No
Data monitoring committee
No

Publications

  • Hyldegaard O, Nekludov M, Arnell P, Nedrebo T, Karlsson Y, Madsen MB, Skrede S, Dos Santos VM, Svensson M, Perner A, Vinkel J, Kjellberg A, Rosen A, Douglas J, Bruun T, Hardt C, Norrby-Teglund A, Hedetoft M. Use of Hyperbaric Oxygen in Patients with Necrotizing Soft Tissue Infections: A Scandinavian Multicenter, Prospective, Observational Cohort. Infect Dis Ther. 2025 Aug;14(8):1715-1738. doi: 10.1007/s40121-025-01184-5. Epub 2025 Jul 4.

    PubMed 40613866

  • Vinkel J, Buil A, Hyldegaard O. Blood from septic patients with necrotising soft tissue infection treated with hyperbaric oxygen reveal different gene expression patterns compared to standard treatment. BMC Med Genomics. 2025 Jan 14;18(1):12. doi: 10.1186/s12920-024-02075-3.

    PubMed 39810178

  • Vinkel J, Rib L, Buil A, Hedetoft M, Hyldegaard O. Key pathways and genes that are altered during treatment with hyperbaric oxygen in patients with sepsis due to necrotizing soft tissue infection (HBOmic study). Eur J Med Res. 2023 Nov 10;28(1):507. doi: 10.1186/s40001-023-01466-z.

    PubMed 37946314

  • Vinkel J, Rib L, Buil A, Hedetoft M, Hyldegaard O. Investigating the Effects of Hyperbaric Oxygen Treatment in Necrotizing Soft Tissue Infection With Transcriptomics and Machine Learning (the HBOmic Study): Protocol for a Prospective Cohort Study With Data Validation. JMIR Res Protoc. 2022 Nov 25;11(11):e39252. doi: 10.2196/39252.

    PubMed 36427229

  • Palma Medina LM, Rath E, Jahagirdar S, Bruun T, Madsen MB, Stralin K, Unge C, Hansen MB, Arnell P, Nekludov M, Hyldegaard O, Lourda M, Santos VAMD, Saccenti E, Skrede S, Svensson M, Norrby-Teglund A. Discriminatory plasma biomarkers predict specific clinical phenotypes of necrotizing soft-tissue infections. J Clin Invest. 2021 Jul 15;131(14):e149523. doi: 10.1172/JCI149523.

    PubMed 34263738

  • Bergsten H, Madsen MB, Bergey F, Hyldegaard O, Skrede S, Arnell P, Oppegaard O, Itzek A, Perner A, Svensson M, Norrby-Teglund A; INFECT Study Group. Correlation Between Immunoglobulin Dose Administered and Plasma Neutralization of Streptococcal Superantigens in Patients With Necrotizing Soft Tissue Infections. Clin Infect Dis. 2020 Oct 23;71(7):1772-1775. doi: 10.1093/cid/ciaa022.

    PubMed 31916575

Questions about this trial

What is this clinical trial studying?

An observational study of Soft Tissue Infections and Necrotizing Fasciitis, run by Karolinska Institutet at 5 sites in 3 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 23 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Sweden, Denmark, 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prognostic/diagnostic value (ROC curves: specificity, sensitivity, predictive values) of classification and severity scores in NSTIs (time frame: 3 months - further oservation up to 24 month may apply). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01790698, which also lists 6 linked publications.

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 23 Apr 2018.

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