Cefepime/Zidebactam

In a clinical study, Zaynich (Zidebactam/Cefepime, WCK 5222) demonstrated over 97 percent clinical efficacy in treating seriously ill patients with infections caused by carbapenemresistant (including meropenem-resistant) Gram-negative pathogens. The study design was unique as it encompassed a range of severe infections, including hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), bloodstream infections (BSI), complicated intra-abdominal infections (cIAI), and complicated urinary tract infections (cUTI). 17 percent of these patients also had concurrent BSI thus further escalating the therapeutic challenge. The overall clinical efficacy of Zaynich across indications was 98 percent at the test-of-cure (TOC), which was 7-10 days after completion of treatment, while it was 100 percent for BSI, HABP/VABP and cIAI and 97.3 percent for cUTI. Notably, Zaynich also demonstrated high pathogen eradication rates (microbiological cure) including for tougher-to-treat HABP/VABP (91 percent) and BSI patients (100 percent). Taking into account the results from this clinical study as well as several patients successfully treated under compassionate use in India and US, lives of more than 100 critically ill patients, infected with life-threatening XDR Gram-negative infections have been saved with administration of Zaynich. Conducted across 15 top-rated tertiary care hospitals nationwide, this clinical study exclusively involved patients with confirmed carbapenem-resistant (including meropenem-resistant) infections, identified through advanced molecular rapid diagnostic technologies. The infecting pathogens were a diverse range of extensively drug-resistant (XDR) Gram-negatives such as Acinetobacter spp., Pseudomonas spp., Klebsiella spp., and E. coli. Treatment durations ranged from 7 to 21 days. The study protocol was duly approved by Drugs Controller General of India (DCGI). This study underscores the potential of Zaynich as a life-saving antibiotic, particularly for carbapenem-resistant infections. Current highly compromised treatment options are colistin and polymyxins, which are marred with significant toxicity and efficacy limitations. The significance of these findings is amplified by the world-wide threat posed by antimicrobial resistance. Zaynich targets all the Gram negative pathogens identified as critical priorities by the US Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO).