Personalized Needs in Clostridium Difficile Infections (SPECIFY)
Scoring Personalized Needs in Clostridium Difficile Infections for Fidaxomixin Therapy
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Athens, Grèce, 10676
- 5th Department of Internal Medicine, Evangelismos Athens General Hospital
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Athens, Grèce, 11527
- 1st Department of Internal Medicine, "G.Gennimatas" General hospital
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Athens, Grèce, 11527
- 1st Department of Internal Medicine, Laikon General Hospital
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Athens, Grèce, 11527
- 3rd Department of Internal Medicine, Sotiria General Hospital
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Athens, Grèce, 12462
- 4th Department of Internal Medicine, Attikon University Hospital
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Athens, Grèce, 15126
- 2nd Department of Internal Medicine, Sismanogleion General Hospital
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Magoula, Grèce, 10918
- 1st Department of Internal Medicine, Thriassio General Hospital
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Magoula, Grèce, 10918
- 2nd Department of Internal Medicine, Thriasio General Hospital
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Maroúsi, Grèce, 15123
- 2nd Department of Oncology, Mitera Hospital
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Piraeus, Grèce
- Infections Unit Tzaneion General Hospital
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Pátra, Grèce, 36504
- Department of Internal Medicine, Patras University Hospital
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Thessaloniki, Grèce, 54248
- 1st Department of Internal Medicine, AHEPA University Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Age equal to or more than 18 years
- Both genders
- Diarrhea defined as at least 3 episodes of unformed stools in the last 24 hours according to the Bristol stool chart
- 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cas uniquement
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
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Clostridium difficile infection
Patients with Clostridium difficile-associated diarrhea for development of biomarkers
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Blood sampling
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Definition of prognostic biomarker
Délai: 12 months
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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
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12 months
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Athanasios Skoutelis, MD, Evangelismos Athens General Hospital
- Chaise d'étude: Evangelos J Giamarellos-Bourboulis, MD, PhD, Attikon Hospital
- Chercheur principal: George Chrysos, MD, PhD, Tzaneion Piraeus General Hospital
- Chercheur principal: Styliani Symbardi, MD, PhD, Thriassio Elefsis General Hospital
- Chercheur principal: Zoi Alexiou, MD, PhD, Thriassio Elefsis General Hospital
- Chercheur principal: Kostantinos Syrigos, MD, PhD, Sotiria General Hospital
- Chercheur principal: George Daikos, MD, PhD, Laikon Athens General Hospital
- Chercheur principal: Panagiotis Gargalianos, MD, PhD, G.Gennimatas Athens General Hospital
- Chercheur principal: Malvina Lada, MD, PhD, Sismanogleion General Hospital
- Chercheur principal: Charalambos Gogos, MD, PhD, University Hospital of Patras
- Chercheur principal: Ilias Athanasiadis, MD, PhD, Mitera General Hospital
- Chercheur principal: Symeon Metallidis, MD, PhD, AHEPA Thessaloniki University Hospital
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CL01
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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