MON4STRAT

Stratified clinical treatment interventions meeting patient-specific efficacy (pharmacodynamics) while at the same time lowering the risk of emergence of drug resistance (EDR) and minimizing adverse effects are particularly needed in Hospital-acquired and Ventilator-Associated pneumonia [HAP/VAP] where morbidity, mortality and health care costs remain high. β-lactam antibiotics are at the cornerstone of most effective treatments of HAP/VAP, but dosage adaptations remain difficult because available models (i) focus mainly on efficacy (neglecting EDR and dose-related side effects) and (ii) are derived from population data which imperfectly fit individual patient’s needs due to large, rapid and difficult-to-predict variations of blood levels.
Current methods for monitoring β-lactam blood levels are slow and require complex instruments not usable at bed-side. Yet, generating easily, rapidly and cost-effectively real data usable at the patient’s bed-side should improve outcomes of β-lactam treatments. This is what 3 out of the 11 partners of the MON4STRAT consortium have recently developed (patent pending).
Thus the objective of the Project is to integrate both (i) state-of-the-art PK/PD and EDR profiles AND (ii) real-time/patient-specific free β-lactam blood levels monitored at the patient’s bed-side according to the patented assay for developing and implementing a new approach to (i) stratify the HAP/VAP patients according to their specific response, (ii) to propose immediately applicable dose adjustments during treatment and thus (iii) to improve efficacy while reducing risk of EDR or adverse effects.
The MON4STRAT approach will be validated through a prospective, multicentre, randomized clinical trial with150 adults. Its applicability in paediatrics will be tested through an observational study with 70 children/neonates.
Being generic in nature, MON4STRAT will be replicable to other infectious conditions.