Assessing the Efficacy and Safety of Eravacycline vs Ertapenem in Complicated Intra-abdominal Infections in the Investigating Gram-Negative Infections Treated With Eravacycline (IGNITE 1) Trial

Abstract

Clinicaltrials.gov Identifier: NCT01844856.

Resistance Trends and Treatment Options in Gram-Negative Ventilator-Associated Pneumonia

“…One potential advantage of eravacycline is the availability of an oral formulation. In the phase III IGNITE1 and IGNITE4 clinical trials twice-daily IV eravacycline was non-inferior to ertapenem or meropenem among patients with complicated intra-abdominal infections [88, 89]. In a phase III (IGNITE2) clinical trial of hospitalized patients with complicated urinary tract infections, eravacycline was inferior to levofloxacin [90]; however, patients receiving IV eravacycline responded better than those receiving oral eravacycline.…”

Evaluation of Eravacycline: A Novel Fluorocycline

“…The efficacy and safety of ERV in management of cIAI were evaluated in one phase II and two phase III, randomized, double‐blind, active controlled trials: the IGNITE1 and the IGNITE4 trials Table . The phase II study evaluated the efficacy and safety of two ERV dosing regimens, 1.5 mg/kg every 24 hours and 1 mg/kg every 12 hours, compared to ertapenem 1 g every 24 hours for 4–14 days.…”

“…Randomized, Double‐blind, Double‐dummy, Comparative, Noninferiority, Multicenter, multinational (N=541) , …”

“…Upon the success of the ERV dosing regimen in the phase II trial, the phase III trial was initiated. The IGNITE1 trial was a randomized, double‐blind, active controlled trial which compared intravenous ERV 1.0 mg/kg every 12 hours to intravenous ertapenem 1.0 g daily in 541 adults with cIAI . The primary end point was clinical response at the TOC visit in the microbiological intent‐to‐treat (micro‐ITT) population, the modified intent‐to‐treat (mITT) and clinically evaluable (CE) populations.…”

Eravacycline for treatment of complicated intra-abdominal infections: the fire is not ignited!

“…This large phase 3 study enrolled 541 patients who were randomized to receive either intravenous (IV) eravacycline (1.0 mg/kg/12 h; 270 patients) or IV ertapenem (1.0 g daily; 271 patients). At the test-of-cure visit in the microbiologically intent-to-treat population (446 subjects), the clinical cure rates were 86.8% and 87.6% respectively demonstrating non-inferiority of eravacycline to ertapenem (13).…”