Comparative study of prescribing patterns of tigecycline for trial patients versus non-trial patients.

BACKGROUND Comparing published trial patients and non-trial patients in clinical practice, clinicians often doubt whether critically ill patients are sufficiently represented in randomised clinical trials. PATIENTS AND METHODS This study evaluated the extent of infection with multidrug-resistant (MDR) pathogens, anti-microbial combination therapy, off-label use and targeted-treatment in trial patients versus non-trial patients. RESULTS Tigecycline therapy was prescribed for off-label use in more than half of the non-trial patients; 77% of trial patients received study medication as first-line therapy in contrast to 25% of non-trial patients (p<0.001). Tigecycline therapy was targeted for 27% of trial patients versus 73% of non-trial patients (p<0.001). Ninety-six percent of non-trial patients were treated for nosocomial infections compared to 23% of trial patients (p<0.001). In one out of 22 (4.5%) trial patients an ESKAPE pathogen was found, whereas rates of vancomycin- resistant Enterococcus faecium, methicillin-resistant Staphylococcus aureus and extended spectrum-β lactamase- producing Enterobacteriaceae ranged between 13/165 (8%) and 23/165 (14%) for non-trial patients. CONCLUSION Tigecycline was used for less critical populations in clinical trials than in clinical practice. Our findings confirm the particular need of potent substances such as tigecycline for critically ill patients.