A Clinical Research Study to Evaluate the Safety and Efficacy of Tigecycline in the Treatment of Selected Serious Infections Caused by Vancomycin-Resistant Enterococcus (VRE) or Methicillin-Resistant Staphylococcus Aureus (MRSA)
Collecte de données
Infections bactériennes+5
+ Infections bactériennes et mycoses
+ Maladies Transmissibles
Étude thérapeutique
Résumé
Date de début de l'étude : 1 octobre 2003
Date à laquelle le premier participant a commencé l'étude.To evaluate the safety and efficacy of tigecycline in the treatment of selected serious infections caused by VRE. The primary efficacy endpoint will be the clinical response for all subjects.
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.174 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: * Male or female subjects aged 18 years or older * Isolation of one of the following multi-antibiotic resistant bacteria: vancomycin-resistant Enterococcus faecium, vancomycin-resistant Enterococcus faecalis, or methicillin-resistant Staphylococcus aureus, alone or as part of a polymicrobial infection * Have a confirmed diagnosis of a serious infection (eg, bacteremia \[unless due to an excluded infection\], complicated intra-abdominal infection, complicated skin and skin structure infection, or pneumonia) requiring administration of intravenous (IV) antibiotic therapy Exclusion Criteria: * Subjects with any concomitant condition or taking any concomitant medication that, in the opinion of the investigator, could preclude an evaluation of a response or make it unlikely that the contemplated course of therapy or follow-up assessment will be completed or that will substantially increase the risk associated with the subject's participation in this study * Anticipated length of antibiotic therapy less than 7 days * For subjects with VRE, known or suspected hypersensitivity to tigecycline or linezolid, or other compounds related to these classes of antibacterial agents (eg, oxazolidinones, tetracyclines, minocycline, doxycycline). For subjects with MRSA, known or suspected hypersensitivity to tigecycline or vancomycin, or other compounds related to these classes of antibacterial agents (eg, tetracyclines, minocycline, doxycycline)