Ceftolozane/tazobactam

(Zerbaxa®)

Zerbaxa®

Drug updated on 9/4/2024

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

loading GIF

Summary
This AI-generated content is provided without warranty, with no liability accepted for reliance on it. Learn more.

  • Zerbaxa (ceftolozane/tazobactam) is indicated in combination with metronidazole for patients 18 years or older for the treatment of complicated intra-abdominal infections (cIAI) caused by designated susceptible microorganisms. It is also indicated in adult and pediatric patients (birth to less than 18 years old) for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis caused by designated susceptible microorganisms, and 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.
  • This summary is based on the review of 17 systematic review(s)/meta-analysis(es). [1-17]
  • Clinical Cure and Microbiological Response in PA Infections: Ceftolozane/tazobactam (TOL-TAZ) showed no significant difference compared to other regimens, including ceftazidime-avibactam, imipenem-cilastatin-relebactam, and cefiderocol, with RRs of 1.04 (95% CI: 0.94-1.15) and 0.97 (95% CI: 0.81-1.17).
  • Complicated Intra-Abdominal Infections (cIAIs): TOL-TAZ demonstrated similar clinical cure rates compared to carbapenems in clinically evaluable (93.6% vs. 93.7%), microbiologically evaluable (93.0% vs. 94.5%), and modified intention-to-treat (85.9% vs. 87.7%) populations.
  • Complicated Urinary Tract Infections (cUTIs): TOL-TAZ exhibited higher clinical cure (92%) and microbiological eradication (83%) rates than piperacillin/tazobactam (78% and 63%, respectively).
  • Gram-Negative Bacterial Infections: TOL-TAZ showed advantages in clinical cure (OR, 1.62; 95% CI, 1.05-2.51) and microbiological eradication (OR, 1.43; 95% CI, 1.19-1.71), particularly in treating Pseudomonas aeruginosa infections.
  • TOL-TAZ exhibited similar rates of adverse events, including treatment-emergent adverse events and serious adverse events, compared to other antimicrobials, with no significant differences observed across multiple studies.
  • There was no increased risk of Clostridium difficile infection associated with TOL-TAZ, and it showed a lower risk of acute kidney injury compared to polymyxin/aminoglycosides.
  • TOL-TAZ demonstrated a favorable safety profile in newborns, infants, and children when treating multidrug-resistant Gram-negative infections, with no specific adverse events reported.
  • There is no population types or subgroups information available in the reviewed studies.

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
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

Clinical Practice Guidelines