This article is more than 5 years old. Information may no longer be current.
Zerbaxa noninferior to meropenem for treating nosocomial pneumonia
Click Here to Manage Email Alerts
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
Reference:
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.