Zerbaxa is noninferior to meropenem for the treatment of adult patients with ventilated nosocomial pneumonia, or VNP, according to phase 3 data from the ASPECT-NP trial presented at the European Congress of Clinical Microbiology & Infectious Diseases.
Results from the trial were the basis of a supplemental new drug application accepted by the FDA in February for a priority review of Zerbaxa (ceftolozane/tazobactam, Merck) to treat adults with nosocomial pneumonia, including ventilator-associated pneumonia caused by susceptible gram-negative microorganisms.
The combination is currently indicated in the United States to treat adults with complicated UTIs and, in combination with metronidazole, to treat adults with complicated intra-abdominal infections.
“Patients who already have a serious medical condition or a compromised immune system, especially those who require intrusive treatment with a tube going into their body, are at high risk for contracting nosocomial pneumonia,” Ignacio Martin-Loeches, MD, PhD, vice chair of intensive care medicine at St. James’s University Hospital in Dublin, told Infectious Disease News. “Nosocomial pneumonia is a serious infection associated with high rates of death, yet there [are] very little data available in this critically ill patient population. New treatment options are desperately needed, and ceftolozane/tazobactam has demonstrated both safety and efficacy in treating these medically vulnerable patients.”
In the study, Martin-Loches and colleagues randomly assigned patients with VNP 1:1 to receive 3 g ceftolozane/tazobactam or 1 g meropenem through IV infusion over 1 hour every 8 hours for 8 to 14 days.
According to the study findings, among 726 participants in the intent-to-treat (ITT) population, ceftolozane/tazobactam was found to be noninferior to meropenem for the primary endpoint of 28-day all-cause mortality, 24% vs. 25.3%, respectively. Additionally, the researchers reported that in the study’s secondary endpoint, defined as clinical cure at test of cure 7 to 14 days after the end of therapy, ceftolozane/tazobactam was again found to be noninferior to meropenem, 54.4% to 53.3%, respectively.
An analysis of outcomes for each pathogen showed that clinical and microbiologic response rates for ceftolozane/tazobactam were comparable to meropenem for gram-negative respiratory tract pathogens, Martin-Loeches and colleagues reported.
Among 233 participants in the microbiologically evaluable (ME) population with a gram-negative pathogen at baseline, clinical cure rates were 75.2% and 66.7% and microbiologic response rates were 69.9% and 62.4% for ceftolozane/tazobactam and meropenem, respectively, according to a news release. Results were consistent among 511 participants in the microbiologic ITT population, with clinical cure rates of 73% and 67.9% for ceftolozane/tazobactam and meropenem, respectively.
“The ceftolozane/tazobactam 3-gram dose regimen is an efficacious and well-tolerated treatment option for critically ill patients with ventilated, gram-negative nosocomial pneumonia,” the researchers concluded. – by Bruce Thiel
Kollef M, et al. Abstract P1917. Presented at: ECCMID; April 13-16, 2019; Amsterdam.
Martin-Loeches I, et al. Abstract 302. Presented at: ECCMID; April 13-16, 2019; Amsterdam.
Disclosures: Martin-Loeches reports serving as a consultant for Polyphor, Gilead and Merck and receiving an educational grant from Grifols.