During or after antibiotic treatment, antibiotic residues impair the intestinal microbiota
(gut flora) and lead to adverse effects such as the emergence of bacterial resistance or the
occurrence antibiotic-associated diarrhoea (AAD) including antibiotic-induced C. difficile
infection (CDI). The spread of resistant Gram-negative bacteria and the increasing number and
severity of CDI are considered as worldwide public health threats.
Da Volterra is a biotechnology company developing a novel product, DAV132 (a medical device
in Europe), intended to prevent these antibiotic adverse effects. Da Volterra is planning to
carry out a phase 2-3 randomized controlled trial (RCT) of DAV132 in the prevention of
antibiotic-induced CDI. The RCT will involve hospitalized patients aged ≥50 years old and
treated with predefined antibiotic classes known to increase the risk of CDI. The incidence
of CDI in this population is unknown, yet, incidence is an important determinant for the
required sample size.
Therefore, the main objective of the current study is to assess CDI incidence in patients ≥50
years of age treated with predefined antibiotic classes.
In addition, to optimise the target population of the DAV132 RCT, the effect of the
predefined antibiotic agents on the intestinal microbiota will be assessed. Furthermore,
biomarkers predictive of CDI occurrence might help identify patients at high risk for the
disease, which could further optimise the RCT. No validated biomarkers have been described in
the literature yet. Assessment of potential biomarkers is another aim of the present study.