Trial record 1 of 6 for:    Open Studies | "Fasciitis, Necrotizing"
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Systems Medicine to Study NSTIs (INFECT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Karolinska Institutet
Sponsor:
Collaborators:
Rigshospitalet, Denmark
Karolinska University Hospital
Blekinge County Council Hospital
Sahlgrenska University Hospital, Sweden
University of Bergen
Helmholtz Centre for Infection Research
Wageningen University
University of Lyon
LifeGlimmer GmbH
Anagnostics Bioanalysis GmbH
Lee Spark NF Foundation
Tel Aviv University
Information provided by (Responsible Party):
Anna Norrby-Teglund, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01790698
First received: February 4, 2013
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

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.


Condition
Soft Tissue Infections
Necrotizing Fasciitis
Necrotizing Soft Tissue Infections

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Improving Outcome of Necrotizing Fasciitis: Elucidation of Complex Host and Pathogen Signatures That Dictate Severity of Tissue Infection

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect of IVIG and HBO-therapy on mortality rates in matched (defined by severity scores and aetiology) NSTI patients [ Time Frame: 3 months - further observation up to 24 month may apply ] [ Designated as safety issue: No ]
  • Presence of hypotension, multiorgan failure, or fatal outcome of NSTI in relation to microbiologic aetiology [ Time Frame: 3 months - further observation up to 60 month may apply ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Bacterial isolates, whole blood, plasma, tissue


Estimated Enrollment: 500
Study Start Date: January 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Hospitalized patients with NSTI

Criteria

Inclusion Criteria:

Necrotizing soft tissue infections

Exclusion Criteria:

Patients under the age of 18 years

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01790698

Contacts
Contact: Ole Hyldegaard, MD ole.hyldegaard@regionh.dk

Locations
Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Ole Hyldegaard, MD       ole.hyldegaard@regionh.dk   
Contact: Anders Perner, MD       anders.perner@regionh.dk   
Sub-Investigator: Erik Jansen, MD         
Principal Investigator: Ole Hyldegaard, MD         
Sub-Investigator: Anders Perner, MD         
Sub-Investigator: Michael Tvede, MD         
Norway
University of Bergen Recruiting
Bergen, Norway, 5021
Contact: Steinar Skrede, MD, PhD       steinar.skrede@helse-bergen.no   
Contact: Trond Bruun, MD       trond.bruun@helse-bergen.no   
Sweden
Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden, SE-416 50
Contact: Per Arnell, MD       per.arnell@vgregionen.se   
Blekinge Hospital Recruiting
Karlskrona, Sweden, SE-371 85
Contact: Ylva Karlsson, MD       ylva.karlsson@ltblekinge.se   
Karolinska University Hospital Recruiting
Stockholm, Sweden, SE-171 76
Contact: Folke Lind, MD, PhD       folke.lind@karolinska.se   
Sponsors and Collaborators
Karolinska Institutet
Rigshospitalet, Denmark
Karolinska University Hospital
Blekinge County Council Hospital
Sahlgrenska University Hospital, Sweden
University of Bergen
Helmholtz Centre for Infection Research
Wageningen University
University of Lyon
LifeGlimmer GmbH
Anagnostics Bioanalysis GmbH
Lee Spark NF Foundation
Tel Aviv University
  More Information

Additional Information:
No publications provided

Responsible Party: Anna Norrby-Teglund, Professor, Coordinator of INFECT, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01790698     History of Changes
Other Study ID Numbers: INFECT-FP7305340
Study First Received: February 4, 2013
Last Updated: October 28, 2013
Health Authority: Sweden: Regional Ethical Review Board
Denmark: Danish Health and Medicines Authority
Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency
Norway: Ethics Committee

Keywords provided by Karolinska Institutet:
Necrotizing fasciitis
Streptococcus pyogenes
Staphylococcus aureus
Immunopathogenesis

Additional relevant MeSH terms:
Fasciitis
Soft Tissue Infections
Fasciitis, Necrotizing
Musculoskeletal Diseases
Infection
Skin Diseases, Bacterial
Bacterial Infections

ClinicalTrials.gov processed this record on July 29, 2014