Morrisette to launch pediatric antimicrobial resistance consortium with ceftazidime/avibactam

Imagine a world without effective antibiotics. You better be imagining a world without humans.

And antimicrobial resistance (AMR) – the ability of bacteria, viruses, and fungi to withstand medicines – is one of the world’s most dire threats. The World Health Organization estimates that AMR was responsible, either directly or as a contributor, to nearly five million deaths in 2019.

Taylor Morrisette is trying to do something about that. Morrisette is planning to launch a multicenter consortium of 10-15 academic medical centers and community-based acute care facilities across the United States.*

The consortium will provide data on ceftazidime-avibactam (CZA), in which the clinical pharmacist and antimicrobial expert at the Medical University of South Carolina (MUSC) sees great potential. CZA combines a well-established third generation cephalosporin with a non-beta-lactam beta-lactamase inhibitor and has been approved for use in adults since 2015. CZA was approved for use in pediatric patients 3 months and older in 2019, and in patients younger than 3 months (at least 31 weeks gestational age) in 2024.

“There is an urgent and unmet clinical need for real-world data surrounding the use of novel antibiotics in the pediatric population to help guide appropriate therapy,” said Morrisette, assistant professor of clinical pharmacy and outcomes sciences at the MUSC College of Pharmacy. “Although randomized controlled trials are the gold standard for evaluating the efficacy of interventions, the clinical studies that led to the approval of many novel antimicrobials include very few patients infected with drug-resistant bacteria. Even though this is the population in which these antibiotics will be used.”

By conducting a retrospective, observational cohort of pediatric patients treated with CZA, Morrisette will leverage the consortium to solve a dearth of clinical data. Few companies invest in research for novel antibiotics, which are typically less profitable, and fewer still invest in clinical studies for them. Fewest of all invest in pediatric clinical studies of novel antibiotics. The world’s most vulnerable population is in increasing peril.

Real-world, observational cohorts that are conducted after drug approval evaluating novel antimicrobials are essential for front-line clinicians, as they provide instrumental health outcomes information regarding the utility of novel agents in specific patient populations, conditions, and bacterial phenotypes beyond those provided by conventional randomized controlled trials. 

Clinicians need this information about the CZA, which has shown potent in vitro activity against numerous resistant Gram-negative pathogens, including carbapenem-resistant Enterobacterales (CRE) and Pseudomonas aeruginosa exhibiting difficult-to-treat-resistance (DTR). 

Numerous real-world, retrospective studies have demonstrated that multiple novel antimicrobials, including CZA, represent viable options for use against resistant pathogens in the adult population. Despite this accumulating evidence in adults, there is a substantial void of data to guide the appropriate use of CZA in children with the most resistant pathogens. 

“Antimicrobial resistance is continuing to rise to devastating rates internationally and contributes significantly to morbidity and mortality,” Morrisette said. “The development and integration of novel antimicrobials in clinical practice are imperative to enhance patient outcomes.”

* Funding for this research was provided by Abbvie Inc.