Assessment of safety and tolerability profiles after iclaprim administration in complicated skin and skin structure infection from the ASSIST-2 clinical trial (Arpida's Skin and Skin Structure Infection Study-2)

Abstract number: P547

Hadvary P., Dryden M., O'Hare M., Sidarous E., Danker W., Leighton A., Islam K.

Objective: To compare the safety and tolerability of iclaprim (ICL) with that of linezolid (LZD) in the ASSIST-2, randomised, multicentre, double-blind, Phase III clinical trial.

Methods: Patients with cSSSI were randomised to one of two treatment arms: intravenous ICL 0.8 mg/kg q 12 hours or 600 mg intravenous LZD q 12 hours and received 10–14 days treatment. The use of systemic or topical antibiotics, steroids or Type IA/III anti-arrhythmic drugs was prohibited during the study. Concomitant aztreonam and/or metronidazole were allowed.

Results: Safety and tolerability data were obtained from 494 patients in the ITT population (ICL: 250; LZD: 244). Treatment-emergent adverse events (AEs) were reported in 56% of patients (ICL 54%; LZD 59%). In general, ICL was better tolerated than LZD, with fewer patients reporting AEs in all categories (drug-related, severe, serious, and those that led to discontinuation of the patient from the study). The AEs were generally mild to moderate in intensity in both treatment arms. A listing of AEs that were possibly or probably related to study drug (>5%) is shown in the table.

Conclusions: ICL exhibits a good safety profile and was well tolerated in patients suffering from cSSSI. AEs of generally mild to moderate intensity were observed. These results indicate that iclaprim has an excellent safety and tolerability profile in patients with cSSSI.

Table: AEs possibly or probably related to study drug in >2% of patients