Critical care

Sepsis, hospital-acquired and ventilation-acquired pneumonia (HAP/VAP) and acute respiratory distress syndrome (ARDS) are interconnected conditions that affect patients treated on intensive care units. Often caused by multidrug resistant pathogens, these diseases have a serious impact on global health, especially for vulnerable patient populations. The long-term outcome is an important aspect and has to be included in investigations.

Clinical trials in sepsis have remained unsuccessful over decades, resulting in lack of causal treatment and high unmet medical need. The lack of success is due in part to patient heterogeneity; they can exhibit widely varying immunological responses as well. Likewise, the emergence of multidrug resistant pathogens and lack of newly discovered antibiotic classes are representing everyday problems. Similarly, there is no specific therapy for ARDS.

Yet these diseases present great need for improved diagnostic, preventive, and therapeutic strategies. For sepsis, a personalized medicine approach offers potential and has become a research priority for clinicians, patients, and their families. HAP and VAP represent everyday clinical challenge for antibiotic selection and calls for development of new agents. Progress has been made in defining diagnostic criteria for a first episode of VAP. In the case of ARDS, investigators are exploring ways of subdividing the disease to identify patients at risk, develop targeted therapy, and inform clinical trial design.

Parexel has deep experience in clinical trials in this area, with a medical team of board-certified intensive care physicians with relevant clinical experience. Medical expertise encompasses sepsis, ARDS, and HAP/VAP, as well as nosocomial and community-acquired pneumonia and COVID-19.

Our delivery staff with complicated infections, ICU and critical care experience number more than 200 across all functions and all geographical regions.  The medical team is complemented by multi-disciplinary dedicated subject matter experts in regulatory strategy, biostatistics, clinical development, feasibility, and operational strategy.

Further, Parexel maintains a close partnership with the European Clinical Research Alliance on Infectious Disease (Ecraid). Aiming to counteract the increased threat of new pathogens, Ecraid advances clinical research in the field of infectious disease by coordinating Europe’s largest academia-driven, self-sustainable, “warm base” clinical research network.