Eravacycline effective in difficult intra-abdominal infections

Last Updated: 2016-11-22

By Reuters Staff

NEW YORK (Reuters Health) - In patients with complicated intra-abdominal infections, the novel synthetic antibiotic eravacycline from Tetraphase Pharmaceuticals may be as good as ertapenem, according to a new study funded by the company.

In a paper online November 16 in JAMA Surgery, Dr. Joseph Solomkin of the University of Cincinnati College of Medicine, Ohio, and colleagues note that eravacycline is designed to be active against acquired tetracycline-specific resistance mechanisms.

The researchers studied 541 hospitalized patients with complicated intra-abdominal infections requiring surgical or percutaneous intervention. Among these were intra-abdominal abscesses, peritonitis and complicated appendicitis.

The patients were randomized to eravacycline, 1.0 mg/kg every 12 hours, or ertapenem, 1.0 g every 24 hours, for a minimum of four 24-hour dosing cycles.

Test-of-cure evaluation was conducted 25 to 31 days after the first dose of the study drug and a follow-up visit was conducted 38 to 50 days later. Patients remained hospitalized for the entire course of drug therapy.

Clinical cure was defined as complete resolution or significant improvement of signs or symptoms of the index infection with no need of additional antibacterial therapy, surgical, or radiological intervention.

Treatment-emergent adverse events were more common in the eravacycline group than in ertapenem group; severe or life-threatening treatment-emergent adverse events were seen in 13 patients in each group.

In the microbiological intention-to-treat population (220 eravacycline and 224 ertapenem patients) the rates of clinical cure at the test-of-cure visit were 86.8% in the eravacycline group and 87.6% in the ertapenem group, a non-significant difference.

The researchers say eravacycline met both the U.S. Food and Drug Administration and the European Medicines Agency primary endpoints of noninferior clinical efficacy versus ertapenem.

Dr. Solomkin reported ties to Tetraphase as did other authors. Four are employees of the company.

Dr. Solomkin did not respond to requests for comments.

SOURCE: http://bit.ly/2f1OHri

JAMA Surg 2016.