Neutrophil Extracellular Traps and Neonatal (PV4991) & Pediatric Sepsis (PV5063)

NCT ID: NCT02567305

Last Updated: 2017-06-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2020-01-31

Brief Summary

This study is designed to assess the role of neutrophil extracellular traps (NETs) in neonatal and pediatric sepsis as well as to evaluate markers of NETs formation as early predictors of neonatal and pediatric sepsis.

Detailed Description

Severe infection resulting in sepsis is recognized as a leading cause of morbidity and mortality worldwide (Stehr and Reinhart, 2013). The incidence of sepsis in developed nations has been increasing while overall mortality is decreasing, but still remains around 30% (Mayr et al., 2014). Moreover, morbidity in survivors is often functionally devastating, and may include neurological impairment, chronic organ dysfunction, increased days admitted to hospital, and high rates of mortality postdischarge (Prescott et al., 2014). Emotional, social, and financial costs to individuals and health care systems are immense (Brun-Buisson et al., 2003).

Neutrophils are the first line of innate immune defense against infectious agents. In addition, neutrophils' ability to eliminate pathogens by phagocytosis and/or degranulation, it has recently been demonstrated that neutrophils can bind to and kill a wide range of microorganisms by forming neutrophil extracellular traps (NETs) (Brinkmann et al., 2004). This novel mechanism consists of the release of web-like structures of DNA decorated with histones and antimicrobial proteins, known as NETs. Microbes are immobilized in these traps, which contain a lethal concentration of antimicrobial agents killing a broad range of microorganisms, including gram-negative and gram-positive bacteria, fungi, viruses, and protozoa (Brinkmann et al., 2004, Fuchs et al., 2010, Camicia et al., 2014).

The role of NETs in pediatric infection is not well understood. We hypnotize that children are capable of forming NETs and that NETosis plays an important role in pediatric sepsis. This study is designed to assess the role of neutrophil extracellular traps (NETs) in neonatal and pediatric sepsis as well as to evaluate markers of NETs formation as early predictors of neonatal and pediatric sepsis.

Conditions

Sepsis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Actual Sepsis

For infants below 44 weeks inclusive of corrected age clinical sepsis is defined, according to the Expert Meeting on Neonatal and Pediatric Sepsis (Report on the Expert Meeting on Neonatal and Pediatric Sepsis - 8 June 2010, EMA London). Confirmed sepsis is defined as positive culture for pathogens in a sample from a normally sterile site and at least one laboratory sign or clinical sign (not shown)

For children above 44 weeks corrected age clinical sepsis is defined according to the Goldstein criteria (Goldstein et al, 2005). Confirmed sepsis: positive culture for pathogens in a sample from a normally sterile site and at least one laboratory sign or clinical sign (not shown)

Markers of NET formation

Intervention Type: OTHER

i.e. Plasma DNA, Histone, MPO, DNase

Suspected Sepsis

None of the above.

Markers of NET formation

Intervention Type: OTHER

i.e. Plasma DNA, Histone, MPO, DNase

Interventions

Markers of NET formation

i.e. Plasma DNA, Histone, MPO, DNase

Intervention Type: OTHER

Other Intervention Names

Typical biomarkers of NETosis

Eligibility Criteria

Inclusion Criteria

1. Signed informed consent by the parent or guardian of the patient

2. Chronological age below 90 days (= neonatal branch) or below 18 years (pediatric branch)

3. Suspicion of sepsis infection

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Medical Center Hamburg-Eppendorf

Hamburg, , Germany

Site Status: RECRUITING

Altona Children's Hospital

Hamburg, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Michael Boettcher, M.D.

Role: CONTACT

m.boettcher@uke.de

+4915222815153

Konrad Reinshagen, M.D. Ph.D.

Role: CONTACT

k.reinshagen@uke.de

+494088908232

Facility Contacts

Michael C Boettcher, M.D.

Role: primary

m.boettcher@uke.de

+4915222815153

Michael Boettcher, M.D.

Role: primary

m.boettcher@uke.de

+4015222815153

Other Identifiers

PV4991 & PV5063

Identifier Type: -

Identifier Source: org_study_id