CLINICAL INDEPENDENT RESEARCH
FAR-ICI
Clinical trials are considered essential for advancing scientific research. Thanks to them, new drugs and treatments may become available, but their initiation and execution are costly; hence, in over 70% of cases, they are typically sponsored by the industry. In recent years, the unit has coordinated several of these trials; however, the need to promote independent clinical, research that seeks to address issues identified by healthcare professionals in the National Health System has arisen. Leading innovation in the field of drug development and the application of personalized medicine techniques inherently involves the clinical evaluation of these interventions. Currently, the unit has coordinated the implementation of industry- sponsored clinical trials and is leading two independent clinical trials in the field of infectious diseases:
SePkLin Study
Patients with severe systemic infections experience numerous physiological alterations that impact the pharmacokinetics In this regard, optimal pharmacokinetic and pharmacodynamic values for Linezolid are not achieved in 50% of sepsis patients..
In the current clinical trial,a total of 692 patients undergoing treatment with linezolid will be included over 36 months. In the intervention group (active PK), population pharmacokinetic models will be applied for dose adjustment, whereas in the control group (non-PK), standard doses of 600 mg will be administered every 12 hours.
Likewise, response models will be developed to maximize the likelihood of treatment success through the combination of clinical, , genetic, and microbiological biomarkers.
Additionally, pharmacogenetic biomarkers will be validated to provide early guidance on the patient's exposure to the drug.
Until now, no clinical trial has investigated the benefit of individualizing linezolid doses based on Pk/Pd parameters. In this context, SePkLin will provide healthcare professionals with evidence in this regard and generate response prediction models that have the potential to alter the prognosis of patients with severe infections undergoing treatment with this drug.
This trial has been funded by the Carlos III Health Institute within the Independent Clinical Research (ICI) call (AES2021).
SePkLin ALCOVID-19
Phase II clinical trial to evaluate the efficacy and safety of inhaled ethanol in the treatment of early-stage COVID-19 (ALCOVID-19).
The emergence of new pathogens such as SARS-CoV-2, for which there are no effective commercially available drugs, compels clinicians to explore alternative alternative therapeutic approaches such as compounding and the off-label use of medications. The current project focuses on conducting a clinical trial to assess the effectiveness of ethanol administered via inhalation in institutionalized patients diagnosed with COVID-19.
This treatment could be easily implemented in any healthcare facility, with the primary hypothesis being the reduction of disease progression through the direct administration of ethanol in the primary sites of the virus's initial replication the upper respiratory tract.
This is an independent clinical trial (Nº EUDRACT: 020-001760-29), recently authorized by the Spanish Agency of Medicines and Medical Devices and Galician Ethics and Research Committee, promoted by the Spanish Society of Hospital Pharmacy, and co-financed by ACIS/Xunta de Galicia under the “Traslaciona” Program.
EudraCT number 2020-001760-29
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