Database Lock COMBACTE-CDI

The case/control database for COMBACTE-CDI has been locked, after achieving a massive 95% return rate for requested case report forms.

The cases/controls were identified during the sample collection study in 2018 and comprise several case definitions based on different diagnostic criteria;

• Case defined as difficile toxin positive (gold standard method – CCNA) positive
• Case defined as difficile toxin positive (new novel method –SIMOA)
• Case defined as free toxin negative but positive for a cytotoxigenic strain (by culture or detection of toxin gene)
• Control defined as negative by all assays

The large number of different diagnostic methodologies used in the sample testing period, uniquely enables COMBACTE-CDI to stratify the data in this way.  This enriched case/control study will provide data on the difference in severity of CDI and the risks and outcomes for these different ‘diagnostic types’. There are a paucity of data on these differences, particularly with regard to the new technology of the SIMOA assay. Published clinical trials have often needed to add sensitivity analyses to compensate for different diagnostic methodologies. The different subsets analysed for the COMBACTE-CDI case/control study will enable accurate future clinical trial design.

Dr. Kerrie Davies, Scientific Lead of COMBACTE-CDI from the University of Leeds, on the collaboration within the private public partnership:

“I have been overwhelmed by the response rate for the case/control study; this is due to a huge effort, not only from the COMBACTE-CDI team at Leeds, but also from the National Coordinators and the participating sites in the study. Without the network working together this could never have been achieved.  The case/control data will enable us to further understand the lack of clinical suspicion in the community, where 50% of cases identified by the study were never tested for CDI at the original submitting site. In addition, we will be able to compare the risk factors and outcomes for hospitals versus community CDI cases, and highlight any potential differences in these different healthcare settings.”