In recent years, proliferation of plasmids encoding extended-spectrum β-lactamases (ESBLs) has fueled the rise of multi-drug resistant Gram-negative bacterial infections. Avibactam inhibits class A and C serine β-lactamases, including KPC carbapenemases. While avibactam itself is not bactericidal, it restores the effectiveness of β-lactam antibiotics, including ceftazidime, against ESBL-producing pathogens. The sponsor sought to combine avibactam and the previously approved β-lactam antibiotic, ceftazidime, to treat complicated infections in humans.
Read this case study to learn how Certara tools helped the sponsor:
- Characterize the safety and pharmacokinetic/pharmacodynamic (PK/PD) profile of a novel drug combination
- Understand the effect of patient factors such as age, sex on avibactam PK
- Determine whether organ impairment affects avibactam’s disposition