PHASE 3, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUPS, MULTINATIONAL, TELAVANCIN INTRAVENOUS VERSUS VANCOMYCIN FOR THE TREATMENT OF INTRA-HOSPITALARY PNEUMONIA WITH EMPHASIS IN PATIENTS WITH INFECTIONS DUE TO STAPHYLOCOCCUS AUREUS METHICILLIN RESISTENT

THERAVANCE INC (OMNICARE CLINICAL RESEARCH),0 个研究点目标入组 0 人开始时间: 2006年7月31日最近更新: 2023年9月4日

试验速览

暂无简介。

•1. Men and women ≥ 18 years of age.
•2. Clinical signs and symptoms compatible with acquired pneumonia after at least 48 hours of continuous stay in an acute or chronic care hospital, or acquired within 7 days after being discharged after hospitalization of ≥ 3 days of duration.
•3. Chest x-ray with results compatible with a diagnosis of pneumonia within 48 hours prior to randomization in the study.
•4. Availability of respiratory or sputum specimens appropriate for Gram stain and culture, and venous access for IV dosing.
•5. Willingness to receive intravenous treatment throughout the treatment.
•6. Patients from whom informed consent can be obtained to participate in the study, as defined by the Teaching and Research Committee or the Ethics Committee.

•1. Patient who received more than 24 hours of systemic antibiotic treatment potentially effective for Gram-positive pneumonia immediately before randomization.
•2. Respiratory tract or sputum samples with only Gram negative bacteria in Gram stain or culture.
•3. Patient with confirmed MSSA or S. pneumoniae infection and who will require more than 24 hours of concomitant treatment of the study medication with an antibiotic for coverage against Gram-negative that has activity against MSSA or S. pneumoniae.
•4. Suspicion or confirmation of pulmonary disease that does not allow to evaluate the therapeutic response, cystic fibrosis or active tuberculosis.
•5. Suspicion or confirmation of pneumonia due to Legionella pneumophila.

发起方

THERAVANCE INC (OMNICARE CLINICAL RESEARCH),