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Ceftolozane/tazobactam

(Zerbaxa®)

Zerbaxa®

Drug updated on 4/16/2024

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.

Summary
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  • Ceftolozane/tazobactam (Zerbaxa) is indicated for the treatment of Complicated Intra-abdominal Infections in adults when used with metronidazole, and for treating Complicated Urinary Tract Infections including Pyelonephritis in adults and pediatric patients. It is also used for adults with Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia.
  • Twenty studies provided insights into the safety, effectiveness, and considerations for specific populations or subgroups related to ceftolozane/tazobactam compared to other antimicrobial agents.
  • The drug showed comparable performance against infections caused by Pseudomonas aeruginosa and complicated intra-abdominal infections when compared with novel β-lactams such as ceftazidime-avibactam and cefiderocol. Its efficacy was similar to carbapenems, making it a potential alternative option.
  • For cases of nosocomial pneumonia, ceftolozane-tazobactam emerged as a preferred antibiotic based on network meta-analysis results. Additionally, its use among newborns and pediatric populations demonstrated favorable outcomes, especially against multi-drug-resistant gram-negative infections.
  • Compared with treatments involving polymyxins and aminoglycosides, Zerbaxa had a significantly lower risk of causing acute kidney injury, indicating a better nephrotoxicity safety profile. Observational data suggested its utility in contexts of bloodstream infections due to generally favorable responses.
  • High clinical success rates were observed while using the drug for treating Multi-drug Resistant Organisms, specifically MDR & XDR strains of Pseudomonas aeruginosa, highlighting its value against highly resistant pathogens.
  • Comparative studies highlighted the nuanced positioning of Zerbaxa depending on the type of infection, resistance patterns, and healthcare settings; cost-effectiveness analyses also underscored its potential.
  • Subpopulation considerations revealed promising outcomes with ceftolozane/tazobactam for neonates and children suffering from MDR Gram-negative infections. Patients with complicated UTIs experienced better clinical outcomes and lower resistance rates compared to treatments with piperacillin/tazobactam, emphasizing Zerbaxa's role in urinary tract infections.

Product Monograph / Prescribing Information

Document TitleYearSource
Zerbaxa (ceftolozane/tazobactam) prescribing information.2022Merck Sharp & Dohme LLC, Rahway, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Effectiveness of novel β-lactams for pseudomonas aeruginosa infection: A systematic review and meta-analysis. 2024American Journal of Infection Control
Comparing novel antibiotics and carbapenems for complicated intra-abdominal infections: A systematic review and meta-analysis of randomized controlled trials.2023International Journal of Antimicrobial Agents
New antimicrobials for the treatment of neonatal sepsis caused by multi-drug-resistant bacteria: A systematic review. 2023Antibiotics
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 trials.2023Journal of Global Antimicrobial Resistance
The efficacy and safety of ceftolozane-tazobactam in the treatment of GNB infections: A systematic review and meta-analysis of clinical studies. 2023Expert Review of Anti-infective Therapy
Efficacy, safety, and tolerability of antimicrobial agents for complicated intra-abdominal infection: A systematic review and network meta-analysis. 2023BioMed Central Infectious Diseases
Global evaluation of the antibacterial activity of ceftolozane/tazobactam against ESBLs-producing Escherichia coli and Klebsiella pneumoniae: A systematic review and meta-analysis.2023Therapeutic Advances in Infectious Disease
A meta-analysis on clinical outcomes of ceftolozane versus piperacillin in combination with tazobactam in patients with complicated urinary tract infections.2022BioMed Research International
Ceftolozane/tazobactam for the treatment of bacteremia: A systematic literature review (SLR).2022Annals of Clinical Microbiology and Antimicrobials
Real-world use of ceftolozane/tazobactam: A systematic literature review.2021Antimicrobial Resistance and Infection Control
Systematic review of the stability of antimicrobial agents in elastomeric devices for outpatient parenteral antimicrobial therapy services based on NHS Yellow Cover Document standards.2021European Journal of Hospital Pharmacy
Ceftolozane/tazobactam for resistant drugs Pseudomonas aeruginosa respiratory infections: A systematic literature review of the real-world evidence.2021Life
Systematic literature review of real-world evidence of ceftolozane/tazobactam for the treatment of respiratory infections.2021Infectious Disease and Therapy
Evaluating the clinical effectiveness of new beta-lactam/beta-lactamase inhibitor combination antibiotics: A systematic literature review and meta-analysis.2021Antimicrobial Stewardship & Healthcare Epidemiology
Ceftolozane-tazobactam combination therapy compared to ceftolozane-tazobactam monotherapy for the treatment of severe infections: A systematic review and meta-analysis. 2021Antibiotics
The use of ceftolozane-tazobactam in the treatment of complicated intra-abdominal infections and complicated urinary tract infections-A meta-analysis of randomized controlled trials.2020International Journal of Antimicrobial Agents
Clinical cure rate and cost-effectiveness of carbapenem-sparing beta-lactams vs. meropenem for Gram-negative infections: A systematic review, meta-analysis, and cost-effectiveness analysis.2020International Journal of Antimicrobial Agents
Ceftolozane/tazobactam for difficult-to-treat Pseudomonas aeruginosa infections: A systematic review of its efficacy and safety for off-label indications.2020International Journal of Antimicrobial Agents
The use of ceftolozane-tazobactam in the treatment of complicated intra-abdominal infections and complicated urinary tract infections-A meta-analysis of randomized controlled trials. 2019International Journal of Antimicrobial Agents

Clinical Practice Guidelines

Document TitleYearSource
EAU guidelines on urology infections.2023European Association of Urology
Infectious Diseases Society of America 2022 guidance on the treatment of extended-spectrum β-lactamase producing enterobacterales (ESBL-E), carbapenem-resistant enterobacterales (CRE), and pseudomonas aeruginosa with difficult-to-treat resistance (DTR-P. aeruginosa). 2022Clinical Infectious Diseases