- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02567305
Neutrophil Extracellular Traps and Neonatal (PV4991) & Pediatric Sepsis (PV5063)
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiekontakt
- Navn: Michael Boettcher, M.D.
- Telefonnummer: +4915222815153
- E-post: m.boettcher@uke.de
Studer Kontakt Backup
- Navn: Konrad Reinshagen, M.D. Ph.D.
- Telefonnummer: +494088908232
- E-post: k.reinshagen@uke.de
Studiesteder
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Hamburg, Tyskland, 20246
- Rekruttering
- University Medical Center Hamburg-Eppendorf
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Ta kontakt med:
- Michael C Boettcher, M.D.
- Telefonnummer: +4915222815153
- E-post: m.boettcher@uke.de
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Hamburg, Tyskland, 22763
- Rekruttering
- Altona Children's Hospital
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Ta kontakt med:
- Michael Boettcher, M.D.
- Telefonnummer: +4015222815153
- E-post: m.boettcher@uke.de
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Signed informed consent by the parent or guardian of the patient
- Chronological age below 90 days (= neonatal branch) or below 18 years (pediatric branch)
- Suspicion of sepsis infection
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
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) |
i.e.
Plasma DNA, Histone, MPO, DNase
Andre navn:
|
Suspected Sepsis
None of the above.
|
i.e.
Plasma DNA, Histone, MPO, DNase
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Neutrophil Extracellular Traps
Tidsramme: 2 weeks
|
Neutrophil Extracellular Traps are measured by serum markers
|
2 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Sepsis
Tidsramme: 2 weeks
|
Sepsis is defined according to the Goldstein criteria 2015.
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2 weeks
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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PV4991 & PV5063
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