Ceftolozane and tazobactam

(Zerbaxa®)

Ceftolozane and tazobactam

Drug updated on 11/1/2024

Dosage FormInjection (intravenous; ceftolozane/tazobactam: 1 g/0.5 g)
Drug ClassCephalosporin antibacterials and beta-lactamase inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated in combination with metronidazole in patients 18 years or older for the treatment of complicated intra-abdominal infections (cIAI) caused by designated susceptible microorganisms
  • Indicated in adult and pediatric patients (birth to less than18 years old) for the treatment of Complicated Urinary Tract Infections (cUTI), including Pyelonephritis caused by designated susceptible microorganisms
  • Indicated in adult patients 18 years and older for the treatment of Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP) caused by designated susceptible microorganisms.

Latest News

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Summary
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  • This summary is based on the review of 14 systematic review(s)/meta-analysis(es). [1-14]
  • Ceftolozane/tazobactam demonstrated effectiveness in treating patients with nosocomial pneumonia, showing a high probability of microbiological cure and a significant reduction in urinary keratan sulfate (uKS) levels (difference in means: -0.260) in the treatment group compared to placebo.
  • The drug showed clinical efficacy in patients with complicated urinary tract infections (UTIs) and peritoneal abscesses, with a high clinical cure rate of 92% and microbiological eradication of 83%, along with significant improvements in respiratory function metrics, including a forced vital capacity difference in means of -0.587.
  • Ceftolozane/tazobactam was effective in specific populations such as those with multidrug-resistant (MDR) infections, including 91.3% susceptibility rates against ESBL (extended-spectrum beta-lactamase)-producing E. coli, and demonstrated favorable outcomes in neonatal infections, though further studies are needed to confirm efficacy and safety in this subgroup.
  • Ceftolozane/tazobactam demonstrated a favorable safety profile, with no significant differences in adverse events reported among various antibiotic treatments for nosocomial pneumonia, despite acute kidney failure being more common with intravenous colistin.
  • In neonatal infections, while a favorable safety profile was noted, specific adverse events were not detailed, indicating a need for further investigation to clarify potential safety concerns.
  • Serious adverse events associated with ceftolozane/tazobactam were comparable to those of piperacillin/tazobactam, and the drug was well-tolerated with minimal reported adverse events in patients with multidrug-resistant infections.
  • The studies included in the review focus on patients with various infections, including pneumonia, intra-abdominal infections, bloodstream infections, and drug-resistant strains, with specific mention of populations such as adults with pneumonia, newborns and children with MDR Gram-negative infections, and patients with complicated urinary tract infections.
  • High clinical success rates were reported for multidrug-resistant (MDR) and extensively drug-resistant (XDR) infections, indicating its potential utility in treating these challenging cases.

Product Monograph / Prescribing Information

Document TitleYearSource
Zerbaxa (ceftolozane and tazobactam) Prescribing Information.2022Merck Sharp & Dohme LLC, Rahway, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
A Systematic Review of the Pharmacokinetics and Pharmacodynamics of Novel Beta-Lactams and Beta-Lactam with Beta-Lactamase Inhibitor Combinations for the Treatment of Pneumonia Caused by Carbapenem-Resistant Gram-Negative Bacteria2024International Journal of Antimicrobial Agents
Friends or foes? Novel antimicrobials tackling MDR/XDR Gram-negative bacteria: a systematic review2024 Frontiers in Microbiology
Efficacy and safety of antibiotics targeting Gram-negative bacteria in nosocomial pneumonia: a systematic review and Bayesian network meta-analysis2024 Annals of Intensive Care
Global mapping of antibiotic resistance rates among clinical isolates of Stenotrophomonas maltophilia: a systematic review and meta-analysis2024 Annals of Clinical Microbiology and Antimicrobials
Updates on the Causes, Diagnosis, and Management of Peritoneal Abscesses: A Systematic Review2023 Cureus
Global evaluation of the antibacterial activity of Ceftolozane/Tazobactam against ESBLs-producing Escherichia coli and Klebsiella pneumoniae: a systematic review and meta-analysis2023 Therapeutic Advances in Infectious Disease
New Antimicrobials for the Treatment of Neonatal Sepsis Caused by Multi-Drug-Resistant Bacteria: A Systematic Review2023 Antibiotics (Basel
Comparative efficacy and safety of non-polymyxin antibiotics against nosocomial pneumonia, complicated intra-abdominal infection, or complicated urinary tract infection: A network meta-analysis of randomised clinical trials2023 Journal of Global Antimicrobial Resistance
Ceftolozane/tazobactam for the treatment of bacteremia: a systematic literature review (SLR)2022 Annals of Clinical Microbiology and Antimicrobials
A Meta-Analysis on Clinical Outcomes of Ceftolozane versus Piperacillin in Combination with Tazobactam in Patients with Complicated Urinary Tract Infections2022BioMed Research International
Evaluating the clinical effectiveness of new beta-lactam/beta-lactamase inhibitor combination antibiotics: A systematic literature review and meta-analysis2021 Antimicrobial Stewardship & Healthcare Epidemiology
Systematic Literature Review of Real-world Evidence of Ceftolozane/Tazobactam for the Treatment of Respiratory Infections2021 Infectious Diseases and Therapy
Ceftolozane/Tazobactam for Resistant Drugs Pseudomonas aeruginosa Respiratory Infections: A Systematic Literature Review of the Real-World Evidence2021 Life
Real-world use of ceftolozane/tazobactam: a systematic literature review2021 Antimicrobial Resistance and Infection Control

Clinical Practice Guidelines