Host Immune Response to Clostridium Difficile Infection (ICD)
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Les sponsors
Hospices Civils de Lyon
ESSAI CLINIQUE: NCT02440438
BioSeek: nct02440438
Mots clés
Abstrait
Clostridium difficile is responsible for up to 25% of reported antibiotic associated diarrhea cases and virtually all cases of pseudomembranous colitis (PMC). The clinical spectrum of C. difficile infection (CDI) varies in severity from asymptomatic carriage to self-limited, mild, watery diarrhea, to PMC, intestinal perforation, toxic megacolon, sepsis, fulminant colitis, and death. In the past decade, the 027/NAP1/BI strain has emerged world-wide and has been implicated in large outbreaks with increased severity, frequent recurrence, and significant mortality. The host immune responses can influence the severity of CDI and play crucial roles in CDI onset, progression, and overall prognosis. Low serum concentrations of antibodies directed against the toxins A&B of C. difficile have been associated with a higher risk of recurrence. However, there are conflicting reports.
Rendez-vous
Dernière vérification: | 09/30/2016 |
Première soumission: | 05/06/2015 |
Inscription estimée soumise: | 05/07/2015 |
Première publication: | 05/11/2015 |
Dernière mise à jour soumise: | 10/04/2016 |
Dernière mise à jour publiée: | 10/05/2016 |
Date de début réelle de l'étude: | 12/31/2013 |
Date d'achèvement primaire estimée: | 07/31/2016 |
Date estimée d'achèvement de l'étude: | 07/31/2016 |
Condition ou maladie
Diarrhea Due to Clostridium Difficile
Intervention / traitement
Biological: Clostridium difficile infection
Phase
-
Groupes d'armes
Bras | Intervention / traitement |
---|---|
Experimental: Clostridium difficile infection | Biological: Clostridium difficile infection Blood samples of 10 mL will be performed every 2 days from the first symptoms of CDI and until clinical recovery and/or hospital discharge |
Critère d'éligibilité
Âges éligibles aux études | 18 Years À 18 Years |
Sexes éligibles à l'étude | All |
Accepte les bénévoles en santé | Oui |
Critères | Inclusion Criteria: - Hospitalized - Suffering from diarrhea related to C. difficile - Confirmed diagnosis of CDI - Informed consent by the patient - Affiliated to the social security regime Exclusion Criteria: - Out-patient - No confirmed diagnosis of CDI - Decline of participation - Patient not affiliated to the social security regime |
Résultat
Mesures des résultats primaires
1. immune response rate [up to 60 days after diagnosis]