The European Society of Clinical Microbiology and Infectious Diseases (ESCMID) and the American Society for Microbiology (ASM) have hosted a conference aiming to help researchers accelerate the development of new antimicrobials and to provide insight into the challenges associated with antimicrobial resistance.
Antimicrobial resistance
The conference, held at Vienna, had several key presentations highlighting important issues in the field of antimicrobials. These include, the optimisation of drug development, strategies to overcome regulatory hurdles, public-private partnerships, innovative trial design, approaches to decrease resistance in new molecules or better access to safe and effective treatment for special populations including children or pregnant women.
The central theme of the conference was widespread drug resistance to antibiotics. Chief strategy officer at AstraZeneca, John H. Rex, stressed that all future clinical trials need to be designed with antimicrobial resistance in mind. He continued to state that bacteria that has developed usual drug resistance (UDR) are more common and has the potential to evolve into multiple-drug resistance (MDS) bacteria or microorganisms with extensive multi-drug resistance.
New antimicrobials are needed to drive an organism back into the less dangerous UDR category, however the development of new antibiotics has become more challenging.
Dr Edward M. Cox, director at the Office of Antimicrobial Products at the U.S. Food and Drug Administration stated that tough economic and scientific hurdles remained in the development of new antimicrobials.
Dr Marco Cavaleri, head of Anti-infectives and Vaccines at the European Medicines Agency, outlined recent evolutions of the regulatory standards for the approval of new antimicrobials in the European Union. He particularly elaborated on the development specific for MDR pathogens in areas of unmet needs, new guidelines on pharmacokinetics and pharmacodynamics (PK/PD) of antibacterial agents, alternative therapies and harmonisation efforts.
To cut the use of antibiotics, Dr Arnold Louie from the University of Florida suggested using higher dosages for a shorter duration. He presented a road of PK/PD principles for decreasing the development of drug resistance in antimicrobials.
The conference also revealed the difficulties of treating pregnant women and infants, as antimicrobials behave differently within the organ systems of a newborn compared to an adult. Professor John van den Anker University Children’s Hospital, Basel, Switzerland also explained how it is difficult to predict how a pregnant woman and her unborn child will react to emergency antimicrobial therapy. Data on drug toxicity and efficacy in pregnant women and children is limited as it is unethical to enrol such people in standard clinical trials.
Professor Anker also highlighted the irony that infants and children are not only excluded from most clinical trials of antimicrobials, but also from accessing orphan drugs due to clauses restricting their use to adults.
The International Neonatal Consortium, established in 2015, called for greater sharing of data, knowledge and expertise to advance innovation in the field of antimicrobials for the non-adult population.
Dr John Bradley University of California in San Diego, U.S. looked at the challenges clinicians and researchers face when treating newborgns with severe infections as the low weight of the infant makes any calculation of dosage per kilogram of body weight virtually impossible. He also discussed the lack of published evidence contributing to tough treatment decisions for paediatric investigators and parents.
On a positive note Professor Mike Sharland, University of London UK, reported that promising studies are now emerging, including strategic trials to re-evaluate older antibiotics for children. He called for new initiatives in Europe and the U.S. to recognise the need for detailed data on newly developed antibiotics and older drugs that have never been tested in this population.
Professor William Hope, a member of the conference’s organising committee, said: “Although the discussions have centred on the issues and challenges surrounding antimicrobials, we have presented strategies to overcome the hurdles and develop new innovative approaches to tackle antimicrobial resistance. The conference provides solutions to some of the issues outlined by the recent high-level United Nations meeting on AMR. ESCMID will continue to support researchers, specialists and policy makers with events providing evidence-based results aimed at improving prevention, diagnosis and treatment of infection-related diseases in all patient populations, including the most vulnerable such as pregnant women and newborns.”