This is a phase III randomized, double-blind, multicenter study comparing the efficacy and safety of intravenous infusions of the investigational drug versus intravenous infusions of the reference drug in the treatment of subjects with complicated urinary tract infections including pyelonephritis. The sponsor of the study is a large world-known Asian pharmaceutical company aiming to get marketing authorization of its product in the Russian Federation.
About 100 patients, man and women 18 to 70 years old, with diagnoses of complicated urinary tract infections including acute pyelonephritis will be enrolled, 80 of which will be randomized for the current study. This will be done by the strength of approximately 10 medical sites in Russia.
The primary objective of the discussed study is to determine if the investigational drug is non-inferior to the reference drug with respect to the proportion of subjects in the microbiological intent to treat (micro-ITT) population who achieve clinical resolution of symptoms at the End-of-Therapy visit.
The secondary subject of the study is, among others, to evaluate the safety profile of the investigational drug in comparison with the comparator.
The double-blind design of this study stipulates that the investigators, clinical site team staff involved in subject care or clinical examinations, statistical team, data-management team and subjects will be blinded regarding the type of therapy until the database lock. Staff at the pharmacy (study nurse, pharmacist) will not be blinded.
Urinary tract infections (UTIs) are in the list of most prevalent infectious diseases, giving a substantial financial burden on society. Unfortunately, there are no good data concerning the prevalence of various types of UTIs and their impact on the quality of life of the affected population; nor are there good data regarding the impact of UTIs on economics in general and that of the health care system in particular. For a well-functioning public health system, such data are urgently needed. This phase III study will help the Sponsor both derive this important data and confirm the efficacy of the investigational product.
OCT has in-depth expertise in organization and conduct of phase III, so called pivotal clinical trials. 44 phase III studies have been conducted by OCT since the company’s establishment in 2005, including one pivotal study in urology. With strong relations with principal investigators in this therapeutic area, at OCT we do our best to provide speedy enrollment and high quality of data derived from a clinical trial.