The US FDA has issued a statement informing members of the public of a clinical trial of doripenem (Doribax®) in the treatment of ventilator-assisted pneumonia that was stopped early due to significant safety concerns.  The study demonstrated excess mortality and a numerically poorer clinical cure rate among subjects treated with doripenem compared to those treated with imipenem-cilastatin (interim results):

• Clinical cure rates (doripenem versus imipenem): 45.6% versus 56.8% (difference of -11.2%; 95% CI -26.3% to 3.8%) in the Microbiological Intent-to-Treat (MITT) population and 49.1% versus 66.1% (difference of -17%; -34.7% to 0.8%) in the Microbiologically Evaluable (ME) population.

• All-cause 28-day mortality rate: 21.5% versus 14.8% (difference of 6.7%; -5.0% to 18.5%) in the MITT population

The FDA is reviewing the trial results and will communicate any new information that results from this investigation.

Of note, doripenem is not approved in the US for the treatment of any type of pneumonia; it is however licensed for this indication in the EU.