20.Dec.2017

OCT completes patient enrollment in an international phase III study

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 in patients with community acquired pneumonia.

More than 340 patients will be included into the study. The enrollment took about 19 months and was completed one week earlier than scheduled, with 25 investigational sites involved. 

This is a full-service project where OCT provides full regulatory and investigational support (including medical writing, site selection, communication with local ethics committees, execution of CTAs with clinical sites and PIs) and performs all activities related to project management, development of project plans, clinical monitoring, logistics, data management and biostatistics.

The subjects of this study are treatment-naïve patients with community acquired pneumonia or patients with previous treatment failure. The total duration of treatment for each patient will be 7-14 days.