A Phase 3, Multicenter, Randomized, Double-Blind, Comparative Study Of The Efficacy And Safety Of Tigecycline Vs Levofloxacin To Treat Subjects Hospitalized With Community-Acquired Pneumonia
Collecte de données
Infections bactériennes+9
+ Infections bactériennes et mycoses
+ Infection Croisée
Étude thérapeutique
Résumé
Date de début de l'étude : 1 novembre 2003
Date à laquelle le premier participant a commencé l'étude.To compare the efficacy and safety of tigecycline with those of levofloxacin in the treatment of subjects with CAP requiring hospitalization. The co-primary efficacy endpoints in the study will be the clinical response in the clinically evaluable population and the clinical response in the clinical modified intent-to-treat population at the TOC visit. The primary efficacy analyses will first determine whether tigecycline is noninferior to levofloxacin. If tigecycline is found to be noninferior, the analyses will determine whether tigecycline is statistically better than levofloxacin.
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.430 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 and female subjects ≥ 18 years of ag. * Subjects hospitalized with CAP for whom IV antibiotic treatment is indicated * The presence of fever (within 24 hours prior to randomization), defined as oral temperature \>38°C/100.4°F, axillary temperature \>38.1°C/100.6°F, tympanic temperature \>38.5°C/ 101.2°F, or a rectal/core temperature \>39°C/102.2°F OR hypothermia (within 24 hours prior to randomization), core temperature \<35°C/95° Exclusion Criteria: * Any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy could be completed (eg, life expectancy \<30 days) * Hospitalization within 14 days prior to the onset of symptoms * Residence in a long-term care facility or nursing home ≥14 days before the onset of symptoms