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

NCT01790698 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 409

Last updated 2018-04-23

No results posted yet for this study

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.

Conditions

  • Soft Tissue Infections
  • Necrotizing Fasciitis
  • Necrotizing Soft Tissue Infections

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    collaborator OTHER
  • Karolinska University Hospital

    collaborator OTHER
  • Blekinge County Council Hospital

    collaborator OTHER
  • Sahlgrenska University Hospital

    collaborator OTHER
  • University of Bergen

    collaborator OTHER
  • Helmholtz Centre for Infection Research

    collaborator OTHER
  • Wageningen University

    collaborator OTHER
  • University of Lyon

    collaborator OTHER
  • LifeGlimmer GmbH

    collaborator UNKNOWN
  • Anagnostics Bioanalysis GmbH

    collaborator UNKNOWN
  • Lee Spark NF Foundation

    collaborator UNKNOWN
  • Tel Aviv University

    collaborator OTHER
  • Karolinska Institutet

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2017-06-30
Completion
2018-01-31

Countries

  • Denmark
  • Norway
  • Sweden

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01790698 on ClinicalTrials.gov