1963. Combined Microbiological Response Rates From Two Phase 3 Trials Demonstrating the Activity of Eravacycline in the Treatment of Complicated Intra-abdominal Infections: A Pooled Analysis of IGNITE1 and IGNITE4

Abstract

BackgroundIGNITE1 and IGNITE4 were randomized, double-blind, double-dummy, multicenter studies which demonstrated the efficacy and safety of eravacycline (ERV) compared with a carbapenem in subjects with complicated intra-abdominal infections (cIAIs). The primary objective of this analysis was to compare the microbiological response at the test-of-cure (TOC) visit for subjects in the two treatment groups.MethodsAppropriate aerobic and anaerobic specimens for culture at the time of the initial procedure were collected from the site of infection and directly inoculated into transport media. Blood and intra-abdominal specimens were cultured, and species identified according to local laboratory practice. Pure cultures of isolates were sent to a reference laboratory for susceptibility analysis to ERV and comparators. Favorable microbiological response rates at the TOC visit were determined for each baseline pathogen isolated from blood and/or intra- or extra-abdominal specimens in the micro-ITT population.ResultsFor subjects with infections caused by Enterobacteriaceae, the overall favorable microbiological response rates for ERV-treated subjects were 86.3% and 91.8% for IGNITE1 and IGNITE4, respectively. The favorable microbiological response rates among pooled ERV-treated subjects are shown in the Table.Baseline PathogenERV No./Total No. (%)Baseline PathogenERV No/Total No. (%) Enterobacteriaceae 277/314 (88.2) Streptococcus viridans group109/120 (90.8) E. coli 223/253 (88.1) E. faecalis 45/54 (83.3) E. cloacae 18/21 (85.7) E. faecium 39/45 (86.7) K. pneumoniae 38/39 (97.4) S. aureus 24/24 (100) A. baumannii 13/13 (100) B. fragilis 74/84 (88.1)ConclusionIn IGNITE1 and IGNITE4 studies, high favorable microbiological responses were observed for ERV. More than 88% of five Enterobacteriaceae spp. and B. fragilis, the most common bacteria associated with intraabdominal infections, were eradicated by ERV. Comparable eradication rates were observed following ertapenem and meropenem therapy, further establishing that ERV was at least as effective as carbapenem treatments. These data support in vitro observations that ERV has broad-spectrum activity against common isolates found in intra-abdominal infections.Disclosures J. Newman, Tetraphase Pharmaceuticals: Employee, Salary. S. Izmailyan, Tetraphase Pharmaceuticals: Employee, Salary. C. Fyfe, Tetraphase Pharmaceuticals: Employee, Salary. L. Tsai, Tetraphase Pharmaceuticals: Employee and Shareholder, Salary.