Prescribing Ceftolozane/Tazobactam for Pediatric Patients: Current Status and Future Implications

Antibiotics are arguably the greatest medical development of the 20th century but these precious resources are being threatened by the continued rise in infections caused by multidrug-resistant bacteria. There is concern that we are on the precipice of a 'post-antibiotic era'. The situation is exacerbated by a stagnation in the pharmaceutical industry in developing new antibiotics, particularly those with activity against some of the most resistant Gram-negative organisms because of significant economic, scientific, and regulatory barriers. One of the products of recent initiatives to reinvigorate the antibiotic pipeline is the agent ceftolozane/tazobactam. Ceftolozane/tazobactam was approved in December 2014 by the US Food and Drug Administration for the treatment of complicated urinary tract infections and complicated intra-abdominal infections for patients 18 years of age and older. The safety and effectiveness of ceftolozane/tazobactam in pediatric patients has not been established in clinical studies. However, with the rise of highly drug-resistant Gram-negative organisms in children and the current climate of ongoing, multiple, and simultaneous antibiotic shortages--particularly of broad-spectrum antibiotics, the potential off-label role of ceftolozane/tazobactam for children needs to be explored while pediatric studies are ongoing. The objective of this opinion piece is to discuss what is currently known about ceftolozane/tazobactam and its potential implications for use in the pediatric population.