Abstract
e66 Volume 37 Number 8S Material and Methods: SHORTEN study is a randomized, multicentric, open-label and phase IV trial designed to prove that a 7-day course with any authorized antibiotic for uncomplicated EB bacteremia according to clinical practice guidelines, is more efficient and equally safe than a 14-day scheme. Two hundred thirty-eight patients will be randomized in 1:1 ratio to experimental/control arm and followed up to 28 days to evaluate clinical and microbiological cure and safety of both arms. The optimal cut-off of PCT level for safely interrupting antibiotic treatment was included as secondary objective. Results: The study is publicly funded (PI-0161-2013) and is being conducted in 3 public hospitals. It has been approved by Spanish Medicines Agency and central Ethical Review Board and for the 3 local Ethic Committees on which is developed. Severity and frequent complications of this infection are cause of a specific surveillance regarding pharmacovigilance applicable in CT as there are several drugs included as IMP. The study organization and coordination requires a multidisciplinary group in order to cover with all the requirements and to obtain real data. Conclusion: The use of drugs from the own hospital provision and the similarities of procedures to daily practice makes this study an example of real pragmatic trial supported for noncommercial clinical research unit in order to accomplish with ethic and legal requirements.
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