The emergence of Antibiotic-resistant bacteria (ARB) is a global problem, having recently been elevated to the top three threats identified by the World Health Organisation (WHO), and subject of numerous national and international government activities, including the Trans-Atlantic Task Force on Antimicrobial Resistance established by the US and EU presidencies. The estimated costs of ARB are around € 1.5 Billion per year in Europe, with an estimated 25,000 deaths (European Center for Disease prevention and Control/European Medicines Agency “time to react”). While the threat of antimicrobial resistance is growing, so are the challenges to bringing forward new therapeutic options for patients infected with resistant organisms. There is a need for a better understanding of how antimicrobial resistance is evolving globally, of what novel molecular mechanisms can be exploited as new forms of antimicrobial therapy and of how to more efficiently develop new treatments so they can be more rapidly brought to patients in need.
The over-arching concept of New Drugs for Bad Bugs (ND4BB) is to create an innovative public-private collaborative partnership that will positively impact all aspects of ARB through the discovery and development of novel agents for the treatment, prevention and management of patients with bacterial infections. COMBACTE is one of the first projects to be launched under this programme with the aim of developing a broad European network of fully capable and Good Clinical Practice (GCP) compliant clinical investigation sites to execute clinical trials enabling the registration of novel agents to be used in the treatment of patients with bacterial infections. The growth and application of the network will be supported with robust microbiologic surveillance data and clinical epidemiologic data. To reduce the time and or cost of clinical development, novel clinical trial designs will be outlined and supported through analysis of publically available and consortium-shared non-clinical and clinical data. In addition to executing the initial set of clinical trials, investigations of patient and pathogen-related biomarkers and the logistical and decision making impact of rapid diagnostics will be conducted.
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