In the past year, Wockhardt's investigational drug, Zaynich™ (Zidebactam/Cefepime), has successfully treated over 35 critically ill patients in India and US who were suffering from extremely drug-resistant infections under compassionate use. This drug has once again demonstrated its effectiveness in managing complex, deep-seated infections.
A recent notable case involved a 64-year-old patient with Type 2 diabetes and hypertension, who had been battling pulmonary and meningeal tuberculosis for about a year. Following a spinal puncture to withdraw cerebrospinal fluid (CSF), the patient developed fever, drowsiness, and unconsciousness, leading to mechanical ventilation and a diagnosis of bacterial meningitis. The condition was confirmed when CSF analysis identified a pan-drug resistant super-bug, Pseudomonas.
Initial treatments with Ceftazidime/Avibactam, Aztreonam, and Meropenem failed to halt the patient's deterioration, marked by persistent fever spikes and increasing infection markers such as C-Reactive Protein (CRP), procalcitonin, and white blood cells (WBC). Due to the significant toxicity and limited ability of Colistin and Polymyxin in crossing the blood-brain barrier, these options were deemed unsuitable.
Faced with no alternatives, a multi-disciplinary team of senior physicians opted to use Zidebactam/Cefepime under compassionate use. Treatment was administered for three weeks. Remarkably, within a short period, the patient's clinical condition improved, with CRP and procalcitonin levels decreasing, and the patient was successfully taken off the ventilator. CSF tests showed the eradication of the pathogen just one week into treatment, and subsequent tests confirmed the absence of Pseudomonas after three weeks of Zidebactam/Cefepime. The patient became clinically stable and all symptoms resolved leading to discharge from the hospital. The drug was well-tolerated throughout the treatment period.
Meningitis, an inflammation of the tissues surrounding the brain and spinal cord, poses significant treatment challenges due to the difficulty of antibiotics in penetrating the blood-brain barrier. This case highlights Zidebactam/Cefepime's remarkable ability to tackle infections in difficult-to-treat body sites.
This represents the first case of nosocomial meningitis caused by multidrug-resistant Pseudomonas successfully treated with Zidebactam/Cefepime, underscoring its potential as a valuable therapeutic option.
Zaynich™, combination of Cefepime and Zidebactam, is Wockhardt's novel patented antibiotic, targeted towards multi-drug resistant Gram-negative infections. It is currently undergoing a multi-national Phase III study which would support its registration/marketing authorization globally. Earlier, multiple Phase I studies including clinical pharmacology studies with Zidebactam/Cefepime were conducted in US. Zaynich™ (Zidebactam/Cefepime) is also undergoing a Phase II study in India for the treatment of carbapenem-resistant infections.