Photo by IDIS researchers.
Researchers from Santiago Health Research Institute (IDIS) has just reached 280,000 euros in funding to develop an independent clinical trial aimed at fight severe bacterial infections or sepsis. It is the only Galician project, supported by the convocation of the Carlos III Health Institute intended to promote independent clinical trials, that is, without dependence on the industry.
The study SePkLin, lead by Angel Fernandez Ferreiro, a specialist pharmacist of the Research and Innovation Unit of the Pharmacy Service of the Santiago de Compostela and Barbanza health area, is a phase IV clinical trial that will include 700 Galician patients. It aims to improve the benefit / risk balance of anti-infective therapy in patients with sepsis through the application of a personalized medicine based on pharmacokinetics.
It will be carried out with the individualization of one of the most used anti-infective treatments in patients with sepsis, linezolid.. And it will be carried out based on blood tests that will detect the amount of antibiotic in the body of each particular patient in order to increase or decrease the dose depending on the situation of each one of them.
Patients with serious infections, such as sepsis, experience numerous physiological changes that affect the amount of antibiotic in their body. Adequate control of the concentrations of the anti-infective drug in the blood and its maintenance within the established ranges will make patients experience less toxicity derived from the drug and obtain a better response to treatment. Consequently, the morbidity and mortality associated with the disease will decrease and, ultimately, the quality of life of patients will improve.
When does sepsis occur?
Sepsis occurs as a result of an inadequate response of the body to an infection, causing failure in multiple organs and endangering the life of the person who suffers it. Its incidence is 104 cases per 100,000 inhabitants per year and can cause the death of up to half of the patients who suffer from it. It is estimated that in Spain 17,000 people die each year from sepsis, more than from breast, colon or pancreatic cancer.
“Many of the antibiotics are used at the same dose for all patients, however, not all patients are the same. This fact causes some to receive less doses than they need (and therefore the treatment will not cure the infection) and other patients receive more doses than they need (which means that they will suffer adverse reactions). Both situations are dangerous and should be avoided, since they have a significant associated mortality ”, highlights Anxo Fernández Ferreiro, IP (principal investigator) of the project.
Independent clinical trials
The Carlos III Health Institute reinforces independent clinical research with the launch of 31 clinical trials, the only one granted in Galicia will take place in Santiago de Compostela and will include patients from the health area of Santiago de Compostela and Barbanza and A Coruña.
“Clinical trials are very important and necessary to advance scientific research and thanks to them, new drugs and treatments may be available, but their implementation and implementation is expensive, which is why in more than 70% of cases they are usually promoted by the industry ”. However, in recent years the need has arisen to promote independent clinical research that gathers initiatives that do not bear the mark of the industry and tries to solve the problems identified by the professionals of the National Health System that affect their patients.
Multidisciplinary research team
The research team is made up of experts in the treatment of infectious diseases, as well as specialists in the clinical application of personalized medicine based on pharmacokinetics and brings together researchers from 7 specialties (internists, intensivists, anesthesiologists, pulmonologists, clinical pharmacists, geneticists and microbiologists), with experience in the management of patients with complicated infections of various origins. In addition, it is worth noting the high participation of clinical-researchers in the calls of the ISCIII, since It has the participation of 5 of the 7 of the Galician doctors Juan Rodés.
The main support for the trial will be provided by the Independent Clinical Research Platform, awarded in the last ISCIII infrastructure call. This Platform provides services in methodological support, pharmacovigilance, statistics and data management as well as in global project management, monitoring and administrative management. In addition, the Network and Innovation Nodes of the Galician Health Knowledge Agency also collaborate, which carry out tasks of dynamization, training and promotion of innovation in open research among their professionals, while providing support to the management.
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