A Comparison of Fidaxomicin and Oral Vancomycin for the Treatment of Clostridium Difficile Infection (CDI) in Hospitalized Patients Receiving Concomitant Antibiotics for the Treatment of Concurrent Systemic Infections
Fidaxomicin
+ Vancomycin
Infections bactériennes+6
+ Infections bactériennes et mycoses
+ Infections à Clostridium
Étude thérapeutique
Résumé
Date de début de l'étude : 1 mai 2017
Date à laquelle le premier participant a commencé l'étude.Administration of concomitant antibiotics (CA) is a known risk factor for treatment failure in the treatment of CDI, as well as for recurrence of CDI. Recent data suggested that among patients receiving CA, fidaxomicin is superior to vancomycin. While these data are encouraging, many clinicians remain unclear on how to apply these data to patient care. Additionally, patients were excluded from the trials presented to the FDA if it was expected that they would require ≥ 7 days of CA. Therefore, the clinical question still remains of how to apply these data to the real world patient who requires a long course of CA and develops CDI while on therapy. We therefore propose an open label, comparative and prospective study of fidaxomicin 200 mg twice daily vs oral vancomycin 125 mg four times daily for the treatment of CDI among patients who are receiving a long course of CA. We hypothesize that fidaxomicin will be superior to vancomycin with respect to clinical cure for patients with CDI.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.144 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria: * Patients 18 years of age or older with \>3 unformed stools/24 hours with positive stool test for C. difficile. * Patients receiving ≥ 1 high or medium risk antibiotic for treatment of an infection other than CDI, for an anticipated duration of ≥ 5 days from the time of enrollment. * High risk: carbapenems, 2nd-4th generation cephalosporins, fluoroquinolones, clindamycin, and beta-lactam/beta-lactamase inhibitor combinations * Medium risk: 1st generation cephalosporin, macrolides\*, and aztreonam * \*The macrolide would be considered to be low risk if patients are receiving intermittent macrolides for prophylaxis only and not for treatment of an acute infection Exclusion Criteria: * Patients with severe-complicated disease that would compromise oral therapy (hypotenstion or shock, ileus or bowel obstruction, megacolon). * Patients with an allergy to oral vancomycin or fidaxomicin. * Patients anticipated to receive metronidazole after enrollment. * Patients who already received oral vancomycin or metronidazole (either oral or intravenous) for \> 24 hours within the preceding 72 hours at the time of enrollment. * Patients anticipated to receive adjunctive C. difficile therapy (rifaxamin, nitazoxanide, tigecycline) after enrollment. * Patients who are on laxatives before they are enrolled into the study, such as lactulose, if: * Patients have had a recent dose adjustment; * Baseline number of bowel movement while on laxatives is unknown. * Number of bowel movements and/or consistency has not changed from baseline. * Patients who have had colostomy or ileostomy * Patients who will have colostomy or ileostomy after enrollment and before study ends * Patients who are or will be on long-term (\>12 weeks) medium or high-risk antibiotics prophylaxis after enrollment
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.2 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
Comparateur actifGroupe II
Comparateur actifObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 2 sites
St. Joseph Mercy Hospital
Ypsilanti, United States