MedicalResearch.com Interview with:
Becky Jayakumar, PharmD
College of Pharmacy
Assistant Professor of Pharmacy Practice
Roseman University of Health Sciences
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Bacteremia (bloodstream infections) due to Gram-negative (GN) bacteria are a frequent cause of severe sepsis and pose serious therapeutic challenges due to multidrug-resistance (MDR). Ceftolozane/tazobactam (C/T) is a novel antipseudomonal cephalosporin combined with an established β-lactamase inhibitor.
This retrospective, observational study evaluated the clinical outcomes of C/T real-world use in severely ill patients. Twenty-two patients with sepsis and/or bacteremia were included; 95% of whom had Pseudomonas aeruginosa that was resistant to almost all antibacterials with the exception of colistin. C/T successfully treated the majority of these complicated patients. In this real-world study, 77% of patients had a clinical response with C/T and 75% had a microbiological response. Clinical success rates were high and mortality rates were similar to other studies in this severely ill population.
MedicalResearch.com: What should readers take away from your report?
Response: C/T successfully treated the majority of these complicated patients in a therapeutic area where new treatments are urgently needed. Use of last-line therapies like colistin, which has known toxicities including nephrotoxicity, has increased in recent years, but even colistin is experiencing resistance. In 2016, the first transferable gene for colistin resistance was identified in China and later in the U.S. This study highlights the need for appropriate initial treatment regimens in these difficult to treat infections.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: The next step is to collect more patients because this was a small subset of 22 patients; we have 48 in total who received medication. We will case match outcomes using historical controls to best available therapy to ensure we have more of a comparator group and to determine we are using a drug that is superior to previous treatments.
MedicalResearch.com: Is there anything else you would like to add?
Response: Conducting real-world studies is a necessary step beyond clinical trial information to ensure we have the background and the data to advance better care for our patients.
Real-world evaluation of ceftolozane/tazobactam in severely ill patients with sepsis and/or bacteremia
Presented at the 28th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Madrid, April 21-24.
Disclosures: Dr. Jayakumar disclosures:
Merck & Co., Inc., 2016-2018
Allergan Sales, LLC 2016 – 2017
Cubist Pharmaceuticals, Inc. 2014 – 2015
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