ASM Microbe

ASM Microbe

September 19, 2015
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IGNITE1: Eravacycline effective in high-risk patients with cIAI

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SAN DIEGO — Recent findings from the IGNITE1 trial demonstrate that eravacycline, a novel fluorocycline antibiotic, was noninferior to ertapenem in the treatment of patients with complicated intra-abdominal infections.

“The phase 3 IGNITE1 trial evaluating eravacycline for the treatment of complicated intra-abdominal infections met its primary efficacy endpoint,” study researcher Larry Tsai, MD, medical director of Tetraphase Pharmaceuticals, told Infectious Disease News. “The data presented at ICAAC show that eravacycline was also effective in certain patient populations with characteristics that put them at higher risk of a poor outcome, including advanced age and altered kidney function. The IGNITE1 data indicate that eravacycline may offer an alternative treatment option for adult patients with complicated intra-abdominal infections, including high-risk patients.”

In the phase 3, double blind, randomized clinical trial, 541 patients with documented complicated intra-abdominal infection (cIAI) were given either 1 mg/kg IV eravacycline (ERV; Tetraphase Pharmaceuticals), administered every 12 hours, or 1 g IV ertapenem (ETP), administered daily, for up to 14 days. Clinical outcomes, determined at the test-of-cure (TOC) visit approximately 28 days after randomization, was the primary endpoint for the microbiological intent-to-treat population, which comprised 446 patients with cIAI.

Results showed that ERV was noninferior to ETP, with overall cure rates of 86.8% and 87.6%, respectively. ERV also was effective in certain high-risk groups. For example, among patients aged 65 years and older, the cure rate with ERV was 88.6% vs. 89.3% with ETP. The cure rate with ERV among those with more severe disease was 87.2%, compared with ETP’s 82.7%. Among patients with one or more abscesses, the cure rate was 87% with ERV and 86.4% with ETP.

Tsai and colleagues also reviewed data on patients with abnormal renal function — an emerging risk factor for worse outcome in patients with serious bacterial infections, they said. In this analysis, the researchers evaluated how baseline creatinine clearance (CrCl) affected the clinical efficacy of ERV. Patients were classified into three groups based on their baseline CrCl, which was calculated using the Cockcroft-Gault equation.

According to Tsai, ERV was effective in treating patients with moderate to severe renal impairment and those with augmented renal function; cure rates for patients with impaired renal function — defined as having a CrCl of less than 60 mL/min — was 79.2% with ERV and 73.7% with ETP. Both treatments had the same cure rate — 87.9% — among patients with augmented renal function, or a CrCl of 130 mL/min or higher. – by John Schoen

References:

Tsai L, et al. Abstract L-834. Presented at: Interscience Conference on Antimicrobial Agents and Chemotherapy; Sept. 17-21, 2015; San Diego.

Tsai L, et al. Abstract L-835. Presented at: Interscience Conference on Antimicrobial Agents and Chemotherapy; Sept. 17-21, 2015; San Diego.

Disclosure: Tsai reports being an employee of Tetraphase Pharmaceuticals. Please see the full study for a list of all other authors’ relevant financial disclosures.