Get the content you want anytime you want.
REGISTER NOW | SIGN IN
ARTICLE

FDA Approves Ceftolozane/Tazobactam for HABP/VABP

JUN 03, 2019 | CONTAGION® EDITORIAL STAFF
The US Food and Drug Administration (FDA) has announced the approval of ceftolozane/tazobactam for the treatment  hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP). The approval of this new indication was granted to Merck & Co., Inc. 

Ceftolozane/tazobactam (Zerbaxa) is a combination treatment of an anti-pseudomonal cephalosporin, ceftolozane, and an extended-spectrum β-lactamase inhibitor, tazobactam. In the United States ceftolozane/tazobactam is indicated for the treatment of complicated urinary tract infections including pyelonephritis caused by certain susceptible Gram-negative microorganisms and also in combination with metronidazole for the treatment of complicated intra-abdominal infections. It was first approved by the FDA in 2014. 

In February, the FDA accepted the sNDA of ceftolozane/tazobactam for priority review to treat patients with nosocomial pneumonia. The acceptance of the sNDA was based on the findings of the ASPECT-NP trial.
Yoav Golan, MD, MS

Yoav Golan, MD, MS



“The approval of Zerbaxa for hospital and ventilator-associated pneumonia is great news for clinicians who care for these types of patients, particularly for those clinicians who work in hospitals or acute-care settings," said Yoav Golan, MD, MS, of Tufts Medical Center, when speaking about the approval. "This is for 2 main reasons. The first is the activity of Zerbaxa against some of the most resistant pathogens that cause pneumonia like multidrug-resistant Pseudomonas. Another reason is that Zerbaxa has relatively balanced activity against resistant pseudomonas as well as another challenging group of gram-negatives known as ESBL producers.”

The study, which compared a new 3-gram dose regimen of ceftolozane/tazobactam with meropenem, enrolled patients who were mechanically ventilated with hospital-acquired/ventilator-associated bacterial pneumonia. A total of 726 participants were enrolled into the trial and were randomized 1:1 to 3 g ceftolozane/tazobactam or 1 g meropenem, both by intravenous (IV) infusion over 1 hour every 8 hours for 8-14 days, stratified by age and diagnosis (vHABP vs VABP).

The primary endpoint was 28-day all-cause mortality (10% non-inferiority margin) and the secondary endpoint was clinical response at test-of-cure (7-14 days after end-of-therapy; 12.5% non-inferiority margin) in the intent-to-treat population (all randomized patients).

Ceftolozane/tazobactam was found to be non-inferior to meropenem for the primary and key secondary endpoints. Mortality was reported to be the highest in meropenem-treated patients with vHABP.

The most common adverse reactions observed in the  trial among patients treated with ceftolozane/tazobactam included elevated liver enzyme levels, renal impairment or failure, and diarrhea.
The drug should not be used in patients with hypersensitivity to components of ceftolozane/tazobactam, as well as hypersensitivity to piperacillin/tazobactam or other members of the beta-lactam class of antibacterial drugs.

At the European Congress for Clinical Microbiology and Infectious Diseases (ECCMID 2019) Contagion® spoke to the poster presenter Marin Kollef, MD, a professor in the Department of Internal Medicine, Pulmonary, and Critical Care at Washington University in St. Louis, Missouri, to learn more about the findings of the study (see video).

 
To stay informed on the latest in infectious disease news and developments, please sign up for our weekly newsletter.


FEATURED
Is there a cure? How long until we find it? And will it work for the majority of people living with HIV?