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.