Tetraphase Pharmaceuticals announced positive results from Phase 3 IGNITE 1 trial of eravacycline for the treatment of complicated intra-abdominal infection (cIAI) compared to ertapenem.
The IGNITE 1 randomized, multi-center, double-blind, double-dummy, non-inferiority (10% margin), global Phase 3 trial was designed to assess the efficacy and safety of eravacycline 1mg/kg IV every 12 hours, compared with ertapenem 1g IV every 24 hours, in the treatment of cIAI (n=536). The primary endpoint was clinical response at the test-of-cure (TOC) visit in the microbiological intent-to-treat (micro-ITT) patient population.
The results demonstrated that eravacycline met the primary endpoint of statistical non-inferiority of clinical response at the test-of-cure (TOC) visit [95% CI:-7.1%; 5.5%]. The primary analysis under the FDA guidance was conducted using a 10% non-inferiority margin in the micro-ITT population.
Eravacycline was previously designated by the Food and Drug Administration (FDA) as a Qualified Infectious Disease Product (QDIP) and granted Fast track status for cIAI and complicated urinary tract infections (cUTI ).
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