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Ceftazidime-avibactam

(Avycaz®)

Ceftazidime-avibactam

Drug updated on 9/4/2024

Dosage FormInjection (intravenous; 2 g ceftazidime [equivalent to 2.635 grams of ceftazidime pentahydrate/sodium carbonate powder] and 0.5 g avibactam [equivalent to 0.551 grams of avibactam sodium])
Drug ClassAntibacterials
Ongoing and
Completed Studies		ClinicalTrials.gov

Indication

  • Indicated for the treatment of complicated intra-abdominal infections (cIAI), used in combination with metronidazole, in adult and pediatric patients (at least 31 weeks gestational age), caused by designated susceptible Gram-negative microorganisms.
  • Indicated for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, in adult and pediatric patients (at least 31 weeks gestational age), caused by designated susceptible Gram-negative microorganisms.
  • Indicated for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), in adult and pediatric patients (at least 31 weeks gestational age), caused by designated susceptible Gram-negative microorganisms.

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Summary
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  • Avycaz (ceftazidime-avibactam) is indicated for the treatment of complicated intra-abdominal infections (cIAI), used in combination with metronidazole, in adult and pediatric patients (at least 31 weeks gestational age) caused by designated susceptible Gram-negative microorganisms; for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, in adult and pediatric patients (at least 31 weeks gestational age) caused by designated susceptible Gram-negative microorganisms; and for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), in adult and pediatric patients (at least 31 weeks gestational age) caused by designated susceptible Gram-negative microorganisms.
  • This summary is based on the review of 13 systematic review(s)/meta-analysis(es). [1-13]
  • Carbapenem-Resistant Enterobacteriaceae (CRE) Infections: Ceftazidime-avibactam (CAZ-AVI) significantly reduced 30-day mortality (RR=0.49) and showed higher clinical cure (RR=2.70) and microbial clearance rates (RR=2.70) compared to polymyxin. Specifically, for CRE bloodstream infections, CAZ-AVI reduced mortality (RR=0.44) more effectively than polymyxin.
  • Complicated Intra-Abdominal Infections (cIAI): CAZ-AVI combined with metronidazole had a higher discontinuation rate due to adverse events compared to meropenem (OR=2.09). CAZ-AVI was comparable in clinical efficacy and microbiological response to carbapenems.
  • Complicated Urinary Tract Infections (cUTIs): Novel antibiotics, including CAZ-AVI, demonstrated a higher clinical cure rate at the test of cure (TOC) and superior microbiological eradication rates compared to conventional antibiotics, with similar safety profiles.
  • General Gram-Negative Infections: CAZ-AVI showed high clinical success rates (45%-100%) in treating various infections caused by carbapenem-resistant and multi-drug-resistant pathogens, including CRE and MDR Pseudomonas aeruginosa.
  • CAZ-AVI demonstrated a similar incidence of acute kidney injury compared to polymyxin but had a lower risk of nephrotoxicity.
  • Renal dosing adjustments of CAZ-AVI were linked to higher mortality in patients with carbapenem-resistant infections, with the emergence of resistance primarily observed in KPC-producing strains.
  • There is no population types or subgroups information available in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
Avycaz (ceftazidime and avibactam) Prescribing Information.2024Allergan USA Inc., Madison, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Ceftazidime–avibactam versus polymyxins in treating patients with carbapenem resistant enterobacteriaceae infections: a systematic review and meta analysis.2024Infection
Efficacy, safety, and tolerability of antimicrobial agents for complicated intra-abdominal infection: a systematic review and network meta-analysis.2023BMC Infectious Diseases
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
Clinical efficacy and safety of novel antibiotics for complicated urinary tract infection: a systematic review and meta-analysis of randomized controlled trials.2023International Journal of Antimicrobial Agents
Efficacy and safety of ceftazidime–avibactam versus polymyxins in the treatment of carbapenem-resistant enterobacteriaceae infection: a systematic review and meta-analysis.2023BMJ Open
The efficacy and safety of eravacycline compared with current clinically common antibiotics in the treatment of adults with complicated intra-abdominal infections: a Bayesian network meta-analysis.2022Frontiers in Medicine
Are there differences between ceftolozane/tazobactam and ceftazidime/avibactam in treating patients with complicated abdominal infections? Evidence from clinical trials.2022Journal of Chemotherapy
Clinical efficacy of renal dosing adjustments of ceftazidime–avibactam in patients affected by carbapenem-resistant gram-negative infections: a systematic review and meta-analysis of observational studies.2022British Journal of Clinical Pharmacology
Ceftazidime-avibactam for the treatment of serious gram-negative infections with limited treatment options: a systematic literature review.2022Infectious Diseases and Treatment
The revival of aztreonam in combination with avibactam against metallo-β-lactamase-producing gram-negatives: a systematic review of in vitro studies and clinical cases.2021Antibiotics
Meta-analysis of clinical outcomes using ceftazidime/avibactam, ceftolozane/tazobactam, and meropenem/vaborbactam for the treatment of multidrug-resistant gram-negative infections.2021Open Forum Infectious Diseases
Choosing optimal antibiotics for the treatment of patients infected with enterobacteriaceae: a network meta-analysis and cost-effectiveness analysis.2021Frontiers in Pharmacology
Novel beta-lactam/beta-lactamase plus metronidazole vs carbapenem for complicated intra-abdominal infections: a meta-analysis of randomized controlled trials.2021Open Forum Infectious Diseases

Clinical Practice Guidelines

Document TitleYearSource
Executive summary of the consensus document of the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC) on the diagnosis and antimicrobial treatment of infections due to carbapenem-resistant gram-negative bacteria.2023Enfermedades Infecciosas y Microbiologia Clinica (English ed.)
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).2022Infectious Diseases Society of America