Zidebactam/Cefepime (ZaynichTM) successful in renal transplant patient with extreme-drug resistant Pseudomonas infection

A recent publication highlights the multidimensional nature of antimicrobial resistance challenges in India and the need for novel versatile antibiotics to tackle growing number of multi-drug resistant infections. A publication, which recently appeared in a peer reviewed journal, European Journal of Clinical Microbiology & Infectious Diseases (EJCMID) describes an exceptionally complex   case of sino-pulmonary infection and skull base osteomyelitis in a renal transplant patient caused by an extreme-drug-resistant Gram-negative bacterial pathogen, Pseudomonas. As all the available antibiotics failed to treat the infection, the patient was successfully treated with Zidebactam/Cefepime (WCK 5222, ZaynichTM) under compassionate grounds following due approval from Drugs Controller General of India.   

Dr. Rajeev Soman, leading infectious diseases specialist and lead author of the publication said “Recalcitrant skull-base bone infections involving extreme-drug-resistant bugs is difficult-totreat as the antibiotic needs to reach the site of infection in adequate concentration and the antibiotic should be active against such pathogens. The present case was even more complicated as controlling the source of infection through surgical intervention was not possible and the patient was severely immunocompromised. With no options left, we treated the patient with last resort combinations of Polymyxins and Fosfomycin, however the patient clinically worsened. To save this patient, we requested for Zidebactam/Cefepime under compassionate use since this antibiotic is currently in Phase 3 trials.  With just few days of treatment, the patient started responding well and finally complete clinical resolution of infection was attained, as verified 2 months after the end of Zidebactam/Cefepime treatment”. The scientific publication also highlighted safety of prolonged use of Zidebactam/Cefepime.  

Dr V Balaji, a co-author of the case study and leading clinical microbiologist said “the pathogen from this patient was Pseudomonas aeruginosa which produced NDM enzyme capable of inactivating last-line safe antibiotic meropenem and a number of other resistance mechanisms. As a result, this pathogen was resistant to range of newer antibiotics such Ceftazidime/Avibactam (often combined with Aztreonam), Meropenem/vaborbactam, Ceftolozane/Tazobactam, and Imipenem/Relebactam and as well as non-β-lactam class mainstay antibiotics such as Amikacin and Ciprofloxacin/Levofloxacin”.

India has become a global hotspot of antibiotic resistance and moreover, the antibiotic resistant mechanisms prevalent in India are much tougher. Transplant and cancer patients are highly vulnerable to antibiotic resistance infections due to need for sustained immunosuppression and frequent exposure to hospitals. In this context, novel antibiotics like Zidebactam/Cefepime are promising life-saving options for such nearly untreatable infections in our country inflicting huge mortality and morbidity,” said Dr. Rajeev Soman.