For urinary tract infections, the agencies agreed upon a primary endpoint to assess the clinical and microbiological response of patients in clinical trials. The agencies also agreed on the maximum number of patients with appendicitis that can be included in clinical trials for the treatment of intra-abdominal infections. Treatment resistant infections were the main focus at the meeting with the regulators reaching an agreement on aspects of clinical trials for antibiotics being developed to treat resistant micro-organisms.
A spokesperson for the EMA said “Regarding multi-drug resistant bacteria, it was acknowledged by the three regulators that it is difficult to conduct randomised clinical studies with patients harbouring infections caused by MDR pathogens for which few therapeutic options are available.”
“Moreover, since these studies would inevitably be small in size and recruit heterogeneous patient populations, the interpretation of the data is expected to be challenging”.
The agencies discussed ways of treating patients in clinical trials and augmenting data from the trials with pharmacokinetic and pharmacodynamic data in multi-drug resistant bacteria.
The EMA also confirmed future meetings will review how to streamline clinical development in areas of unmet medical need.