Clostridium difficile-associated diarrhoea (CDAD) has become the most frequent nosocomial infection in many European hospitals, exceeding infections caused by MRSA. Its impact is considerable, both in terms of human suffering and costs of disease management. A number of factors have contributed to this escalation. On the one hand, the proportion of the European population in the the principal high-risk group, the elderly, is rapidly rising. On the other, there has been a steady increase in strains exhibiting increased virulence and/or enhanced antibiotic resistance. In 2004, the situation was exacerbated by the arrival in Europe of a new hypervirulent strain (ribotype 027) previously confined to N. America, where it has been responsible for a massive increase in CDAD incidence and associated deaths. It is imperative that an overall European strategy to combat this and similar novel variants is devised.

Central to the control of epidemics are the deployment of assays able to rapidly diagnose and monitor the presence and spread of the organism. No such tests currently exist for these new hypervirulent C. difficile strains. It is the overall objective of this proposal is to develop the urgently required rapid, diagnostic assays.

Our objective will be achieved through the complementary skills of a consortium composed 3 SMEs and 4 public sector institutes, each experts in their fields. Suitable diagnostic markers (DNA- and antigen-based) will be identified using a combination of targeted approaches (focusing on toxin and antibiotic resistance determinants), and empirical approaches (DNA arrays and HT-AFLP) to identify unique strain differences. Assay development will be led by the SMEs, using proprietary technologies. Clinical validation will be performed in a certificated reference laboratory. The programme outputs will allow the formulation of a European strategy to combat the considerable threat now being posed to European quality of life by C. difficile.

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