Mumbai: Wockhardt, a global pharmaceutical and biotech company, on Monday announced the successful use of an investigational antibiotic under-trial drug, Zidebactam/Cefepime, to treat a highly drug-resistant skull bone infection and pneumonia in a renal transplant patient. The case involved a 62-year-old man who suffered from sino-pulmonary infection and skull base osteomyelitis (disease with a high risk of complications including neuroinfection) caused by NDM-producing Pseudomonas aeruginosa.
NDM-producing Pseudomonas aeruginosa is a challenging strain of bacteria due to its resistance to most available antibiotics. There is a growing problem of antibiotic resistance in India, where NDM is a prevalent concern with limited treatment options available. The case was published in the European Journal of Clinical Microbiology and Infectious Diseases.
Speaking on this, Rajeev Soman, an infectious diseases specialist and lead author of the European Journal publication, emphasised the difficulty in treating such infections, stating, “Recalcitrant skull-base bone infections involving extreme-drug-resistant bugs are difficult to treat 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.”
In this case, traditional antibiotics had failed, leading to a desperate search for alternatives. The patient was ultimately treated with Zidebactam/Cefepime following approval from the Drugs Controller General of India.
Commenting on the same, V Balaji, a co-author and leading clinical microbiologist, stated, “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.”
The publication not only highlighted the success of Zidebactam/Cefepime in treating the patient but also emphasised the safety of prolonged use of the drug.
Wockhardt’s investigational antibiotic, cefepime/zidebactam, was administered under the guidelines, and the patient responded positively within 48 hours. TDM (therapeutic drug monitoring) was used to individualise the dosage regimen. After 11 weeks of treatment, the patient’s infection was successfully resolved.
Wockhardt is focusing on the field of antibiotics, particularly those effective against multi-drug resistant infections as it has received QIDP Status (Qualified Infectious Disease Product) for 6 of their antibacterial discovery programmes from the US Food and Drug Administration (USFDA).
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