1976. Pooled Analysis of Safety Data from Phase 2 and 3 Clinical Trials Evaluating Eravacycline in Complicated Intra-Abdominal Infections
Session: Poster Abstract Session: Clinical Trials
Saturday, October 6, 2018
Room: S Poster Hall
Posters
  • IDWeek 2018_ERV Pooled Safety_Poster FINAL.pdf (557.5 kB)
  • Background: Eravacycline is a novel, fully-synthetic fluorocycline antibiotic that was evaluated in three comparator-controlled studies for the treatment of complicated intra-abdominal infections (cIAI). The objective of this analysis was to evaluate the safety profile of eravacycline 1 mg/kg IV q12h for the treatment of cIAI.

    Methods: Pooled data from one phase 2 and two phase 3 (IGNITE1 and IGNITE4) clinical trials in cIAI were analyzed. Patients in the trials were randomized to receive eravacycline 1 mg/kg IV q12h, ertapenem 1 g IV q24h, or meropenem 1 g IV q8h for 4-14 days. Overall treatment-emergent adverse events (TEAEs), serious TEAEs, and laboratory assessments were evaluated.

    Results: 576 patients were treated with eravacycline 1 mg/kg IV q12h and 547 patients with comparators (ertapenem and meropenem). Demographic and baseline characteristics were similar among the groups. Overall summary and common TEAEs are presented in Table 1. None of the serious TEAEs or those leading to death were related to the study drug. Clinically notable laboratory abnormalities were relatively uncommon and occurred at similar frequencies in eravacycline- and comparator-treated patients.

    Table 1. Overall Summary of Treatment Emergent Adverse Events – Eravacycline Phase 2 and Phase 3 Clinical Studies

     

    Eravacycline 1 mg/kg IV q12h

    N=576

    n (%)

    Comparators*

    N=547

    n (%)

    Any TEAEs

    217 (37.7)

    152 (27.8)

            Nausea

    40 (6.9)

    5 (0.9)

            Vomiting

    20 (3.5)

    13 (2.4)

            Diarrhea

    13 (2.3)

    8 (1.5)

            Infusion phlebitis

    13 (2.3)

    1 (0.2)

            Pyrexia

    11 (1.9)

    11 (2.0)

            Anemia

    7 (1.2)

    12 (2.2)

    Treatment-related TEAEs

    71 (12.3)

    20 (3.7)

    TEAEs Leading to Discontinuation from Study Drug

    9 (1.6)

    12 (2.2)

    Serious TEAEs

    33 (5.7)

    33 (6.0)

    TEAEs Leading to death

    7 (1.2)

    7 (1.3)

    *Comparators include ertapenem 1 g IV q24h and meropenem 1 g IV q8h

    Conclusion: This pooled analysis demonstrated that eravacycline 1 mg/kg IV q12h was generally well tolerated for the treatment of cIAI when compared to ertapenem and meropenem. Results of the analysis are consistent with those of individual clinical studies and no new safety signals were identified.

    Ekaterina Efimova, PharmD, Melanie Olesky, PhD, Sergey Izmailyan, MS and Larry Tsai, MD, Tetraphase Pharmaceuticals, Watertown, MA

    Disclosures:

    E. Efimova, Tetraphase Pharmaceuticals: Employee , Salary .

    M. Olesky, Tetraphase Pharmaceuticals: Employee and Shareholder , Salary .

    S. Izmailyan, Tetraphase Pharmaceuticals: Employee , Salary .

    L. Tsai, Tetraphase Pharmaceuticals: Employee and Shareholder , Salary .

    See more of: Clinical Trials
    See more of: Poster Abstract Session

    Findings in the abstracts are embargoed until 12:01 a.m. PDT, Wednesday Oct. 3rd with the exception of research findings presented at the IDWeek press conferences.