This is an international, multicenter, double-blind, randomized, controlled, double-dummy study in two parallel groups to evaluate the efficacy and safety of intravenous and oral forms of investigational product.
It is planned to screen treatment-naïve patients with community acquired pneumonia and patients with previous treatment failure. At the moment, several patients have been included with the first patient randomized on May 4, 2016. Over 300 patients are expected to be enrolled.
According to the World Health Organization, lower respiratory tract infections (LRTI), including pneumonia, are the third most common cause of death worldwide. Approximately 3.1 million people died of LRTI across the globe in 2012. Pneumonia is defined as an acute illness associated with symptoms and signs of infection of the lower respiratory tract, with nodular opacities visualized by X-ray examination that cannot be explained by other causes. Community acquired pneumonia refers to pneumonia acquired outside of hospitals or extended-care facilities diagnosed within 48 hours after admission.
In this clinical trial OCT will provide full regulatory and investigational support including medical writing, site selection, performance of all required regulatory activities, communication with local ethics committees, execution of CTAs with clinical sites and PIs, as well as all activities related to project management, development of project plans, clinical monitoring, logistics, data management and biostatistics.