Systems Medicine to Study Necrotizing Soft Tissue Infections (NSTIs).
NCT ID: NCT01790698
Last Updated: 2018-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
409 participants
OBSERVATIONAL
2013-01-31
2018-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Karolinska University Hospital
OTHER
Blekinge County Council Hospital
OTHER
Sahlgrenska University Hospital
OTHER
University of Bergen
OTHER
Helmholtz Centre for Infection Research
OTHER
Wageningen University
OTHER
University of Lyon
OTHER
LifeGlimmer GmbH
UNKNOWN
Anagnostics Bioanalysis GmbH
UNKNOWN
Lee Spark NF Foundation
UNKNOWN
Tel Aviv University
OTHER
Karolinska Institutet
OTHER
Responsible Party
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Anna Norrby-Teglund
Professor, Coordinator of INFECT
Locations
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Rigshospitalet
Copenhagen, , Denmark
University of Bergen
Bergen, , Norway
Sahlgrenska University Hospital
Gothenburg, , Sweden
Blekinge Hospital
Karlskrona, , Sweden
Karolinska University Hospital
Stockholm, , Sweden
Countries
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References
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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.
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.
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.
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.
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.
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.
Related Links
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website of INFECT
Other Identifiers
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INFECT-FP7305340
Identifier Type: -
Identifier Source: org_study_id
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