Wockhardt Limited announced that during last one year, global Phase 3 clinical stage, India-discovered, Zidebactam/Cefepime was successfully used to treat 30 critically-ill patients, several with cancer and organ transplant, across 24 leading Indian tertiary care hospitals under compassionate use. These patients were grappling with a spectrum of challenging life-threatening infections, including hospital-acquired/ventilator-associated pneumonia, empyema (collection of pus in lungs), bloodstream infections, urosepsis, intra-abdominal infections, necrotizing fasciitis (flesh-eating bacterial infection), and osteomyelitis caused by variety of extreme-drug resistant (XDR) Gram-negative pathogens, including Pseudomonas, Klebsiella, E. coli, Acinetobacter, and Serratia. Disturbingly, these pathogens were resistant to last-resort antibiotics such as meropenem, as well as newer antibiotics specifically developed to treat resistant Gram-negative pathogens such as ceftazidime/avibactam, ceftolozane/tazobactam, imipenem/relebactam, and some even to cefiderocol.

Prior to seeking compassionate use of Zidebactam/Cefepime, medical practitioners attempted treating these patients with colistin or polymyxin B, which unfortunately led to severe nephrotoxicity and neurotoxicity without resolving the infections. As a last resort, under compassionate use approval from Central Drugs Standard Control Organisation (CDSCO), Zidebactam/Cefepime was administered to these patients, with treatment durations ranging from one week to eleven weeks. Remarkably, within 1-2 weeks of initiating Zidebactam/Cefepime therapy, patients showed significant clinical improvement, and by the end of treatment, they were clinically and microbiologically cured of these recalcitrant infections.

Zidebactam/Cefepime was tolerated well even when administered up to 11 weeks which was required for unyielding infections such as osteomylietis. It's noteworthy that most of these patients had underlying complications such as cancer, kidney transplant, liver transplant, bilateral lung transplant, bone marrow transplant, immune suppression, and severe renal impairment. Twenty patients had previously failed to respond to antibiotic combinations such as ceftazidime/avibactam + aztreonam + polymyxin B/colistin, while colistin/polymyxin B treatment had proven ineffective in ten patients.

Additionally, eight patients were in septic shock prior to the initiation of Zidebactam/Cefepime therapy. Currently, Zidebactam/Cefepime is undergoing a multinational Phase 3 study, which is expected to facilitate its global registration and marketing authorization. Earlier, several Phase 1 studies, including clinical pharmacology studies, were conducted in the United States.

Wider dissemination of MDR/XDR pathogens in Indian hospitals and also globally underscores the therapeutic challenge faced by the doctors and highlights urgent need of `high-efficacy' antibiotics to manage such life-threatening infections in ICUs.