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A new interesting article has been published in Anaerobe. 2019 Dec; 60:102048. doi: 10.1016/j.anaerobe.2019.06.001. Epub 2019 Jun 12. and titled:

The perils of PCR-based diagnosis of Clostridioides difficile infections: Painful lessons from clinical trials.

Authors of this article are:

Kong LY, Davies K, Wilcox MH.

A summary of the article is shown below:

Diagnostic tests favoured to detect C. difficile infections (CDI) have undergone successive changes. The problem of over-diagnosis with polymerase chain reaction (PCR) testing is recognized in the clinical setting; here we discuss the parallel of the clinical trial setting. We summarize and discuss four examples of the impact of method used to diagnose CDI on clinical trial outcomes. Bezlotoxumab, a human monoclonal antibody neutralizing toxin B, was found to be protective against recurrent CDI (rCDI) in clinical trials. A post hoc analysis showed that the magnitude of the relative reduction in rCDI rates of bezlotoxumab over placebo in patients diagnosed with toxin-based testing was almost double that in patients diagnosed with PCR. SER-109, a microbiome therapeutic developed to prevent rCDI, showed promise in a phase 1b trial, but results were not replicated in a phase 2 trial in which diagnosis was in majority PCR-based. Surotomycin, an oral lipopeptide antibiotic, was found to be non-inferior to vancomycin in phase 2 study, but development was discontinued after unfavourable phase 3 results in which the majority of CDI were diagnosed by PCR. Finally, a C. difficile vaccine program for a toxoid vaccine developed by Sanofi/Pasteur was terminated after interim analysis of a phase 3 trial, in which CDI diagnosis was based solely on PCR. We highlighted the perils of using PCR alone in studies involving different aspects of C. difficile clinical research, including immunotherapies, microbiome-based therapies, treatments, and vaccines. The importance of designing C. difficile clinical trials with careful consideration to the diagnostic testing method cannot be overemphasized.Copyright © 2019 Elsevier Ltd. All rights reserved.

Check out the article’s website on Pubmed for more information:

[link-preview url=https://www.ncbi.nlm.nih.gov/pubmed/31201853 forceshot=true]

This article is a good source of information and a good way to become familiar with topics such as: Clinical trials; Clostridioides difficile; Diagnosis.

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