Comparative efficacy and safety analysis of CSE-1034: An open labeled phase III study in community acquired pneumonia

CSE-1034 is a novel antibiotic adjuvant entity (AAE) with proven activity against broad range of multi-drug resistant (MDR) pathogens causing various bacterial infections. This phase 3 clinical trial was designed to evaluate the efficacy and safety of CSE-1034 therapy for the treatment of community-acquired pneumonia (CAP) patients of Pneumonia Outcomes Research Team (PORT) risk III-IV.

In this multi-centric, controlled, open-labeled phase 3 trial, adult patients with PORT risk III-IV CAP were randomized to receive either intravenous CSE-1034 (3g every 12h) or Ceftriaxone (2g every 12h) for 3-10 days. The primary endpoint was clinical response in clinically-evaluable (CE) population and microbiological eradication in microbiologically-evaluable (ME) population at test of cure (TOC) visits. Secondary endpoints included verification of the primary endpoints across all other visits, treatment duration and safety of patients.

156 patients were screened at 5 study centers of which 93 subjects were enrolled in the study and randomized in CSE-1034 and Ceftriaxone treatment arms. In CE population (n=90), the clinical cure rates at TOC visit were 96% and 64% in CSE-1034 (n=46) and Ceftriaxone (n=44) treatment arms respectively (treatment difference: 32.0%; 95% CI, 15.8%-47.1%). The bacterial eradication in ME population of two treatment arms were 94% (n=36) and 56% (n=27) at TOC visit (treatment difference: 38.9%; 95% CI, 17.8%-57.6%). Overall, the total number of adverse events (AEs) reported in both groups were 21 (22.5%). The AEs rates reported in two treatment arms were 15.2% in CSE-1034 and 29.8% in Ceftriaxone group.

Overall assessment of clinical cure rate, microbiological eradication rate and safety assessment in this study has shown that CSE-1034 is an effective and safe option for the treatment of CAP patients of PORT risk III-IV. Moreover, the superiority of CSE-1034 over Ceftriaxone is also proven.