MON4STRAT - Betalaktaamsete antibiootikumide terapeutiline monitoorimine ventilaatoriga seotud penumoonia korral lastel ja täiskasvanutel
The main objective of the MON4STRAT Project is to improve beta-lactam-based antibiotic therapy of critically-ill patients for moving towards individualized treatments meeting efficacy as well as reduced EDR and adverse effects. The Project aims to develop and demonstrate at the clinical level (by performing exploratory clinical trials), an innovative approach usable directly at the patient bed-side allowing the care-giver to correct and adapt its initial beta-lactam treatment schedule (dosage, dose interval, and duration) to the patient-specific needs as soon as there is a quantitative evidence that the initial treatment is no longer appropriate and is likely to lead to poor clinical outcomes (lack of efficacy) as well as risks of EDR and adverse effects. To reach this objective, we together with the University of Lille will conduct an exploratory, open, randomized clinical trials involving critically-ill paediatric patients suffering from nosocomial pneumonia (HAP/VAP) or neonatal sepsis as appropriate (n=75). Specific objectives are at the level of the individual patient, - to assess the ability to perform real-time monitoring taking into account the specific issues of this population (small amounts of blood; sparse sampling) - to compare measured free beta-lactam blood levels with those predicted from the best available population data Specific objectives are at the population level, - to document how the MON4STRAT approach could help to stratify this population into specific subpopulations (prematures, neonates, children) known to show major differences in drug pharmacokinetics. The study will be conducted in the paediatric and neonatal intensive care units of University Clinics of Tartu and Tallinn Children’s Hospital. About half of the required population is expected to be recruited from Estonia. Finally, throughout the whole Project duration, an important objective shared by all the partners is to pro-actively and strategically optimize the dissemination of the results to the best of the patients, the medical community and European companies collectively interested in fostering further developments including additional large-scale clinical trials to confirm the assets of the MON4STRAT approach and device.