A Phase 3, Randomized, Double-Blind, Double-Dummy, Multicenter, Prospective Study to Assess the Efficacy and Safety of Eravacycline Compared With Ertapenem in Complicated Intra-abdominal Infections (IGNITE1)

NCT01844856 Phase 3 COMPLETED Results posted

This is a Phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety, and pharmacokinetics of eravacycline compared with ertapenem in the treatment of adult complicated intra-abdominal infections (cIAI).

Details

Lead sponsor	Tetraphase Pharmaceuticals, Inc
Phase	Phase 3
Status	COMPLETED
Enrolment	541
Start date	2013-08
Completion	2014-08

Conditions

• Complicated Intra-abdominal Infections

Interventions

• Eravacycline
• Ertapenem
• Placebo

Primary outcomes

• Clinical Response of Eravacycline and Ertapenem Treatment Arms at the Test-of-cure (TOC) Visit in the Microbiological Intent-to-treat (Micro-ITT) Population — TOC visit: 25-31 days after the first dose of study drug
  Clinical response was classified as cure (complete resolution or significant improvement of signs and symptoms of the index infection), failure (death related to complicated intra-abdominal infection \[cIAI\], unplanned surgical procedures or percutaneous drainage procedures, persisting or recurrent infection within the abdomen, postsurgical wound infection, or administration of effective concomitant antibacterial therapy), or indeterminate (outcome was neither cure nor failure, or assessment was not available). Participants who were failures at the End-of-Treatment (EOT) visit (within 24 hours of last dose) were considered failures at the TOC visit. The number of participants with a clinical response classification of cure, failure, or indeterminate is presented.

Countries

United States, Argentina, Bulgaria, Czechia, Estonia, France, Germany, Latvia, Lithuania, Romania, Russia, South Africa, Ukraine