A Phase III, Multicentre, Randomised, Double-Blind, Comparative Study to Evaluate the Efficacy and Safety of Intravenous Ceftaroline Fosamil Versus Intravenous Ceftriaxone in the Treatment of Adult Hospitalised Patients with Community-Acquired Bacterial Pneumonia in Asia

AstraZeneca AB Sweden0 个研究点目标入组 692 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•ï¿½ Males and Females 18 or more years of age
•ï¿½ Lung Infection of Individual not Recently Hospitalized meeting the following criteria: Radiographically-confirmed pneumonia (new or progressive infection site of the lungs) consistent with bacterial pneumonia), AND Acute illness (less than or equal to 7 days duration) with at least three of the following clinical signs or symptoms consistent with lung infection: New or increased cough, Purulent sputum or change in sputum character, Auscultatory findings consistent with pneumonia, Difficulty in breathing, short breath, or decreased partial pressure of oxygen in blood, Fever greater than 38ï¿½C oral or body temperature lower than that required for normal body function( 35ï¿½C), White blood cell count greater than or less than the normal, Greater than 15% immature neutrophils (bands) irrespective of white blood cell count, AND Moderate lung infection
•ï¿½ The subject must require initial hospitalization, or treatment in an emergency room or urgent care setting, by the standard of care
•ï¿½ The subjects infection would require initial treatment with intravenous antimicrobials.
•ï¿½ Female subjects of child-bearing potential, and those who are fewer than 2 years post-menopausal, must agree to, and comply with, using highly effective methods of birth control while participating in this study
•- as per DCGI approval, in India, the upper age limit is 75 years or less

•? Lung Infection of Individual not Recently Hospitalized suitable for outpatient therapy with an oral antimicrobial agent
•? Confirmed or suspected respiratory tract infections attributable to sources other than bacteria from the individuals not recently hospitalized(e.g., ventilator-associated pneumonia, hospital-acquired pneumonia, visible/gross aspiration pneumonia, suspected viral, fungal, or mycobacterial infection of the lung)
•? Non-infectious causes of lung lesion (e.g., pulmonary embolism, chemical pneumonitis from aspiration, hypersensitivity pneumonia, congestive heart failure)
•? Accumulation of pus in the pleural cavity
•? Microbiologically-documented infection with a pathogen known to be resistant to ceftriaxone, or epidemiological or clinical context suggesting high likelihood of a ceftriaxone-resistant typical bacterial pathogen

发起方

AstraZeneca AB Sweden