NCT01790698

Brief 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. 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
409

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
3 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 4, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 13, 2013

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

April 23, 2018

Status Verified

April 1, 2018

Enrollment Period

4.4 years

First QC Date

February 4, 2013

Last Update Submit

April 20, 2018

Conditions

Soft Tissue InfectionsNecrotizing FasciitisNecrotizing Soft Tissue Infections

Keywords

Necrotizing fasciitisStreptococcus pyogenesStaphylococcus aureusImmunopathogenesis

Outcome Measures

Primary Outcomes (1)

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

    3 months - further oservation up to 24 month may apply

Secondary Outcomes (2)

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

    3 months - further observation up to 24 month may apply

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

    3 months - further observation up to 60 month may apply

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hospitalized patients with NSTI

You may qualify if:

  • Necrotizing soft tissue infections

You may not qualify if:

  • Patients under the age of 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

University of Bergen

Bergen, 5021, Norway

Location

Sahlgrenska University Hospital

Gothenburg, SE-416 50, Sweden

Location

Blekinge Hospital

Karlskrona, SE-371 85, Sweden

Location

Karolinska University Hospital

Stockholm, SE-171 76, Sweden

Location

Related Publications (6)

  • 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.

    PMID: 40613866DERIVED

  • 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.

    PMID: 39810178DERIVED

  • 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.

    PMID: 37946314DERIVED

  • 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.

    PMID: 36427229DERIVED

  • 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.

    PMID: 34263738DERIVED

  • 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.

    PMID: 31916575DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Bacterial isolates, whole blood, plasma, tissue

MeSH Terms

Conditions

Soft Tissue InfectionsFasciitis, NecrotizingStaphylococcal Infections

Condition Hierarchy (Ancestors)

InfectionsFasciitisMusculoskeletal DiseasesGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and Mycoses

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Coordinator of INFECT

Study Record Dates

First Submitted

February 4, 2013

First Posted

February 13, 2013

Study Start

January 1, 2013

Primary Completion

June 1, 2017

Study Completion

January 1, 2018

Last Updated

April 23, 2018

Record last verified: 2018-04

Locations

DK(1)NO(1)SE(3)