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Personalized Needs in Clostridium Difficile Infections (SPECIFY)

3. oktober 2017 opdateret af: Evangelos J. Giamarellos-Bourboulis, M.D., University of Athens

Scoring Personalized Needs in Clostridium Difficile Infections for Fidaxomixin Therapy

To develop a score that can predict early from diagnosis of Clostridium difficile infection (CDI) the risk for relapse and of unfavorable outcome. This score can be used in the future to identify patients will benefit from fidaxomicin treatment.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Medical world is nowadays witnessing a sudden increase of the incidence of infections by Clostridium difficile (DCI). This is due in part to the prolongation of survival of patients with major comorbidities like solid tumor malignancies and lymphomas but also to the widespread intake of proton pump inhibitors and of wide-spectrum antimicrobials. It is highly probable that isolates of C.define causing this pandemic are genetically different than isolates of the same species predominating 20 years ago. This hypothesis is developed based on data of the epidemiology of CDI: in old times administration of clindamycin and ampicillin were the main drivers of CDI; recent studies report fluoroquinolones, 2nd and 3rd generation cephalosporins and even vancomycin (i.e. a drug of choice for CDI) to be linked with the development of CDI.

One major hurdle in management of CDI is relapse; the risk of relapse is reported as 15-20% after the first episode; however it is geometrically increased to even 60-80% after the second episode. As a consequence, management of CDI becomes a major health problem.

Fidaxomicin is a novel compound active against species of C.dificille. Results of two recent double-blind, randomized, large scale clinical studies have shown that oral treatment for 10 days with fidaxomicin 200mg bid was non-inferior to oral treatment with vancomycin 125mg q6h. However, the risk of relapse after treatment with vancomycin was close to 25% and with fidaxomicin close to 15%. This difference was statistically significant in both trials outscoring the superiority of fidaxomicin over vancomycin for the management of CDI. Moreover, meta-analysis has shown a significant reduction in mortality by fidaxomicin.

Despite proven superiority, prescription of fidaxomicin is limited to few cases mostly due to high cost. In many countries prescription is restricted to cases of relapsing CDI. Clinical feeling coming both from post-marketing experience as well as from published evidence supports the use of fidaxomicin for cases with risk of death and overt risk of relapse. However, molecular analysis of the C.difficile pathogen cannot be used as a tool for the prediction of relapse since in relapse cases pathogens carry less than 2 single nucleotide variants of the initial isolate. SPECIFY is aiming to develop a score using both clinical and genetic and biomarker data that can efficiently discriminate patients at risk of severe CDI and at risk of relapse of CDI. This score can become in future a tool to discriminate patients at need for treatment with fidaxomicin instead of traditional treatment with metronidazole/vancomycin.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

150

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Grækenland
      • Athens, Grækenland, 10676
        • 5th Department of Internal Medicine, Evangelismos Athens General Hospital
      • Athens, Grækenland, 11527
        • 1st Department of Internal Medicine, "G.Gennimatas" General hospital
      • Athens, Grækenland, 11527
        • 1st Department of Internal Medicine, Laikon General Hospital
      • Athens, Grækenland, 11527
        • 3rd Department of Internal Medicine, Sotiria General Hospital
      • Athens, Grækenland, 12462
        • 4th Department of Internal Medicine, Attikon University Hospital
      • Athens, Grækenland, 15126
        • 2nd Department of Internal Medicine, Sismanogleion General Hospital
      • Magoula, Grækenland, 10918
        • 1st Department of Internal Medicine, Thriassio General Hospital
      • Magoula, Grækenland, 10918
        • 2nd Department of Internal Medicine, Thriasio General Hospital
      • Maroúsi, Grækenland, 15123
        • 2nd Department of Oncology, Mitera Hospital
      • Piraeus, Grækenland
        • Infections Unit Tzaneion General Hospital
      • Pátra, Grækenland, 36504
        • Department of Internal Medicine, Patras University Hospital
      • Thessaloniki, Grækenland, 54248
        • 1st Department of Internal Medicine, AHEPA University Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Patients with Clostridium difficile-associated diarrhea

Beskrivelse

Inclusion Criteria:

  1. Age equal to or more than 18 years
  2. Both genders
  3. Diarrhea defined as at least 3 episodes of unformed stools in the last 24 hours according to the Bristol stool chart
  4. Presence of C.difficile in stool. This is defined as any stool sample positive for the presence of glutamate dehydrogenase (GDH) and for the presence of toxin A and/or B.

Exclusion Criteria:

1. No exclusion criteria exist

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kun etui
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Clostridium difficile infection
Patients with Clostridium difficile-associated diarrhea for development of biomarkers
Andet: Development of biomarkers
Blood sampling
Andre navne:
  • Single nucleotide polymorphisms
  • Serum cytokines

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Definition of prognostic biomarker
Tidsramme: 12 months
Patients with positive score and unfavorable outcome. Unfavorable outcome is defined as at least one of the following: a) number of patients with severe infection at disease onset; b) number of patients who progress into severe infection; c) number of patients with disease recurrence; and d) number of patients who die
12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Athens

Samarbejdspartnere

Hellenic Sepsis Study Group

Efterforskere

  • Ledende efterforsker: Athanasios Skoutelis, MD, Evangelismos Athens General Hospital
  • Studiestol: Evangelos J Giamarellos-Bourboulis, MD, PhD, Attikon Hospital
  • Ledende efterforsker: George Chrysos, MD, PhD, Tzaneion Piraeus General Hospital
  • Ledende efterforsker: Styliani Symbardi, MD, PhD, Thriassio Elefsis General Hospital
  • Ledende efterforsker: Zoi Alexiou, MD, PhD, Thriassio Elefsis General Hospital
  • Ledende efterforsker: Kostantinos Syrigos, MD, PhD, Sotiria General Hospital
  • Ledende efterforsker: George Daikos, MD, PhD, Laikon Athens General Hospital
  • Ledende efterforsker: Panagiotis Gargalianos, MD, PhD, G.Gennimatas Athens General Hospital
  • Ledende efterforsker: Malvina Lada, MD, PhD, Sismanogleion General Hospital
  • Ledende efterforsker: Charalambos Gogos, MD, PhD, University Hospital of Patras
  • Ledende efterforsker: Ilias Athanasiadis, MD, PhD, Mitera General Hospital
  • Ledende efterforsker: Symeon Metallidis, MD, PhD, AHEPA Thessaloniki University Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. oktober 2015

Primær færdiggørelse (Faktiske)

1. december 2016

Studieafslutning (Faktiske)

1. oktober 2017

Datoer for studieregistrering

Først indsendt

8. oktober 2015

Først indsendt, der opfyldte QC-kriterier

9. oktober 2015

Først opslået (Skøn)

12. oktober 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. oktober 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. oktober 2017

Sidst verificeret

1. oktober 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CL01

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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Kliniske forsøg med Development of biomarkers

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