In the relentless battle against highly drug-resistant infections, a team of doctors recently witnessed a glimmer of hope amid the challenges they faced. Their extraordinary efforts and the life they saved highlight the critical need for action. This is not just a story; it is an earnest plea for Emergency Use Authorisation (EUA) for essential antibiotics that can make a profound difference between life and death.
In an intensive care room of a leading hospital in Hyderabad, an 18-year-old patient bravely fought not only his aggressive T-cell leukemia but also a formidable and resistant adversary — Extensively Drug Resistant Pseudomonas aeruginosa. This strain, known for its high resistance to multiple antibiotics, left the medical team with limited and often ineffective treatment options. Despite the administration of last-resort antibiotics, the patient’s condition deteriorated rapidly. Persisting fever spikes, and the infection’s assault on his lungs signalled a grave situation. The bacteria were literally eating up the patient’s face. Time was running out, and his life hung in the balance.
An Indian innovation
In their quest for a lifeline, the doctors turned to a promising antibiotic, cefepime/zidebactam. Developed by Indian researchers, this antibiotic combines two active components to combat drug-resistant gram-negative pathogens, including Pseudomonas aeruginosa. While still undergoing phase 3 trials internationally, this Indian innovation has shown remarkable potential. Under a compassionate use protocol, the necessary approvals were obtained, and the patient received cefepime/zidebactam. Miraculously, signs of clinical improvement began to surface. The patient’s fever subsided, blood cultures turned negative, and the need for oxygen diminished. Slowly but steadily, his strength returned, reigniting hope.
This extraordinary case underscores the urgent importance of granting EUA for antibiotics currently in phase 3 trials or licensed from other countries. The survival of this young patient serves as a poignant reminder of the need for timely access to effective antibiotics for those most in need.
A dire situation
Infection specialists, intensivists, oncologists, and doctors treating severe infections in critically ill and immunocompromised patients are confronted with a grave reality. The scarcity of potent antibiotics to combat drug-resistant infections poses a direct threat to countless lives. It is distressing to witness patients succumb to infections just because the available antibiotics have lost their effectiveness due to rising resistance. The dire situation faced by doctors as they grapple with drug-resistant infections is a devastating reality that cannot be ignored. Each year, millions of lives are lost due to the inadequacy of available antibiotics in the face of these formidable pathogens. The relentless march of drug resistance has rendered once-effective treatments ineffective.
The challenges faced by doctors in combating drug-resistant infections are multifaceted. They must navigate through a shrinking arsenal of effective antibiotics, leaving them with limited choices and often resorting to suboptimal treatments that may have significant side-effects or offer little hope of a cure. The constant race against time, trying to stay one step ahead of the mutating bacteria, adds to the immense pressure and helplessness experienced by doctors on the front lines.
India, a nation that has demonstrated remarkable progress in granting EUA for COVID-19 vaccines, now stands at a critical juncture. We must extend the same level of urgency and commitment to saving the lives of patients who may otherwise succumb to infections resistant to all currently available antibiotics.
While it is true that several antibiotics are licensed within our country based on small clinical studies and of questionable benefit, we must recognise that what we truly need are powerful weapons to fight against drug-resistant infections. Antibiotics that have been thoroughly evaluated or proven to be effective are essential in the battle against superbugs.
Cefepime/zidebactam is a shining example of India’s scientific prowess. Currently undergoing international phase 3 trials, this antibiotic has demonstrated its potential to save lives. By recognising the importance of cefepime/zidebactam and expediting its EUA, we not only save lives within our borders but also extend a helping hand around the globe to countless individuals in desperate need of effective treatment options.
Made by Japan
Cefiderocol, a licenced antibiotic in several countries, developed by a Japanese company, has demonstrated excellent efficacy against drug-resistant infections. It is disheartening that it remains unavailable within our country. The gravity of the cases faced by patients in India demands access to this life-saving antibiotic, and we firmly believe it should be made accessible without delay. However, we must emphasise the importance of responsible and appropriate utilisation of these medications. A collective decision by a team of experienced doctors, including infectious diseases experts should be made mandatory before initiating their use. This will ensure that these powerful antibiotics are administered to patients who will benefit the most while minimising the risk of misuse or overuse.
We implore the authorities to recognise the urgent need for action and acknowledge the immense potential of these life-saving antibiotics. By granting EUA for cefepime/zidebactam, an Indian innovation, and cefiderocol, a globally recognised antibiotic, we can strengthen our arsenal against drug-resistant infections. Their inclusion in the EUA list would not only empower doctors but also instil a renewed sense of hope and confidence among patients and their families. As a nation known for its scientific achievements, we have the opportunity to make a substantial impact on the world stage.
Dr. Abdul Ghafur is Coordinator of the Chennai Declaration on Antimicrobial Resistance (AMR), and Consultant in Infectious Diseases, Apollo Hospital, Chennai
