Biomarkers in Patients With Flesh-eating Bacterial Infections

NCT02180906 | Completed DMC

• 1 other identifier: BIONEC1-MBH-2014
• Study Type: observational
• Target: 169
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the immune response in patients with necrotizing soft tissue infections (NSTI). The investigation will focus on inflammatory and vasoactive biomarkers as prognostic markers of severity and mortality at admission to Rigshospitalet and the following 3 days

Conditions

Necrotizing Soft Tissue Infection; Necrotizing Fasciitis; Gas Gangrene; Fournier Gangrene

Keywords

Fasciitis; Gangrene; Fasciitis, Necrotizing; Soft Tissue Infections; Fournier's Gangrene; Streptococcal septic shock syndrome; Flesh eating bacteria; Meleneys ulcer; Wounds and Injuries; Streptococcus pyogenes; Staphylococcus aureus; Immunopathogenesis; Soft Tissue Infections/blood; Necrosis/blood; Necrosis/diagnosis; Necrosis/mortality; Necrosis/surgery; Prognosis; Risk Factors; Bacterial Infections; Infection; Skin Diseases, Bacterial; Observational study; Biological markers

Outcome Measures

Primary Outcomes (1)

• PTX3, NOx and IL-6 as early markers of disease severity in NSTI patients with and without septic shock

  Primary analysis: Association between PTX3-, NOx-, and IL6-concentration and septic shock (PTX3, NOx) or LRINEC ≥ 6 (IL-6) in NSTI patients at time of admission to Rigshospitalet

  Admission, first 24 hours

Secondary Outcomes (13)

• Mortality

  28, 90, 180 days

• Amputation rate

  During ICU admission (expected average of 8 days)

• ICU-scoring systems

  During ICU admission (expected average of 8 days)

• Multiple organ failure

  During ICU admission (expected average of 8 days)

• Number of debridements

  During ICU admission (expected average of 8 days)

Study Arms (1)

Patients with NSTI

Definition: An infection that requires acute hospitalization with intensive care treatment and/or surgery as a consequence of severe soft tissue infection in subcutis, muscle and/or fascia and are spreading along tissue structures.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All NSTI patients treated at the University Hospital of Copenhagen, Rigshospitalet

You may qualify if:

• Necrotizing soft tissue infection based on surgical findings
• Age \>18 years
• Admitted to/planned to be admitted to the ICU at Rigshospitalet and/or operated for NSTI at Rigshospitalet

You may not qualify if:

• Patients who at the operating theatre were categorized as non-NSTI patients
• Patients undergoing elective orthopedic surgery (non-pathologic fractures, joint replacement surgery, back surgery) at Rigshospitalet
• Age \>18 years
• Patients with ongoing infections

Sponsors & Collaborators

• Ole Hyldegaard: lead
• Seventh Framework Programme: collaborator

Study Sites (1)

Copenhagen University Hospital, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (10)

• Hasham S, Matteucci P, Stanley PR, Hart NB. Necrotising fasciitis. BMJ. 2005 Apr 9;330(7495):830-3. doi: 10.1136/bmj.330.7495.830.

  PMID: 15817551 BACKGROUND

• Sultan HY, Boyle AA, Sheppard N. Necrotising fasciitis. BMJ. 2012 Jul 20;345:e4274. doi: 10.1136/bmj.e4274. No abstract available.

  PMID: 22822005 BACKGROUND

• Golger A, Ching S, Goldsmith CH, Pennie RA, Bain JR. Mortality in patients with necrotizing fasciitis. Plast Reconstr Surg. 2007 May;119(6):1803-1807. doi: 10.1097/01.prs.0000259040.71478.27.

  PMID: 17440360 BACKGROUND

• Muller B, Peri G, Doni A, Torri V, Landmann R, Bottazzi B, Mantovani A. Circulating levels of the long pentraxin PTX3 correlate with severity of infection in critically ill patients. Crit Care Med. 2001 Jul;29(7):1404-7. doi: 10.1097/00003246-200107000-00017.

  PMID: 11445697 BACKGROUND

• Bastrup-Birk S, Skjoedt MO, Munthe-Fog L, Strom JJ, Ma YJ, Garred P. Pentraxin-3 serum levels are associated with disease severity and mortality in patients with systemic inflammatory response syndrome. PLoS One. 2013 Sep 9;8(9):e73119. doi: 10.1371/journal.pone.0073119. eCollection 2013.

  PMID: 24039869 BACKGROUND

• Panacek EA, Marshall JC, Albertson TE, Johnson DH, Johnson S, MacArthur RD, Miller M, Barchuk WT, Fischkoff S, Kaul M, Teoh L, Van Meter L, Daum L, Lemeshow S, Hicklin G, Doig C; Monoclonal Anti-TNF: a Randomized Controlled Sepsis Study Investigators. Efficacy and safety of the monoclonal anti-tumor necrosis factor antibody F(ab')2 fragment afelimomab in patients with severe sepsis and elevated interleukin-6 levels. Crit Care Med. 2004 Nov;32(11):2173-82. doi: 10.1097/01.ccm.0000145229.59014.6c.

  PMID: 15640628 BACKGROUND

• Su YC, Chen HW, Hong YC, Chen CT, Hsiao CT, Chen IC. Laboratory risk indicator for necrotizing fasciitis score and the outcomes. ANZ J Surg. 2008 Nov;78(11):968-72. doi: 10.1111/j.1445-2197.2008.04713.x.

  PMID: 18959694 BACKGROUND

• Kristensen MK, Hansen MB, Madsen MB, Hansen CB, Pilely K, Hyldegaard O, Garred P. Complement Activation Is Associated With Mortality in Patients With Necrotizing Soft-Tissue Infections-A Prospective Observational Study. Front Immunol. 2020 Jan 31;11:17. doi: 10.3389/fimmu.2020.00017. eCollection 2020.

  PMID: 32082310 DERIVED

• Hansen MB, Rasmussen LS, Garred P, Bidstrup D, Madsen MB, Hyldegaard O. Pentraxin-3 as a marker of disease severity and risk of death in patients with necrotizing soft tissue infections: a nationwide, prospective, observational study. Crit Care. 2016 Feb 15;20:40. doi: 10.1186/s13054-016-1210-z.

  PMID: 26880104 DERIVED

• Hansen MB, Simonsen U, Garred P, Hyldegaard O. Biomarkers of necrotising soft tissue infections: aspects of the innate immune response and effects of hyperbaric oxygenation-the protocol of the prospective cohort BIONEC study. BMJ Open. 2015 May 11;5(5):e006995. doi: 10.1136/bmjopen-2014-006995.

  PMID: 25967993 DERIVED

Related Links

• Research website: INFECT-study. Further description of funding from EU 7th Framework Programme

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood and plasma/serum

MeSH Terms

Conditions

Fasciitis, Necrotizing; Gas Gangrene; Fournier Gangrene; Fasciitis; Gangrene; Soft Tissue Infections; Wounds and Injuries; Staphylococcal Infections; Necrosis; Disease; Bacterial Infections; Infections; Skin Diseases, Bacterial

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections and Mycoses; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Marco Bo Hansen, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

• Ole Hyldegaard, MD, PhD

  Rigshospitalet, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ole Hyldegaard

Study Record Dates

• First Submitted: June 29, 2014
• First Posted: July 3, 2014
• Study Start: February 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: February 17, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)