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The FDA approved a new indication for the antibiotic combination ceftazidime and avibactam (marketed as Avycaz), for treatment of hospital-acquired pneumonia and ventilator-associated pneumonia in adults.
The drug was approved originally in 2015 for complicated intra-abdominal infections (in combination with metronidazole) and got another indication in 2017 for complicated urinary tract infections and pyelonephritis.
The ceftazidime and avibactam combination is indicated for health care-associated pneumonias presumed due to gram-negative bacteria such as E. coli, Klebsiella, Enterobacter, and Pseudomonas.
Ceftazidime (sold as Fortaz or Tazicef, or as a generic) is a cephalosporin active against gram-negative (including anti-Pseudomonas activity), gram-positive and anaerobic bacteria.
Avibactam is a β-lactamase inhibitor that protects ceftazidime from degradation by β-lactamase enzymes produced by resistant bacteria.
The new indication was granted based on results of a phase 3 randomized trial enrolling 870 adults with hospital-acquired pneumonias, including VAP. Patients received either meropenem or Avycaz for 7 to 14 days. Patients receviing Avycaz had a 9.6% 28-day mortality (the primary endpoint) compared with 8.3% among patients receiving meropenem.
Avycaz has activity against carbapenem-resistant gram-negative rods (Enterobacteriaceae), as do recently approved antibiotic combinations meropenem-vaborbactam (Vabomere) and ceftolozane-tazobactam (Zerbaxa).