Clostridium Difficile

Clostridium Difficile Infection

Relationship Between C. Difficile Toxins' Serum Level With C. Difficile Infection

Mann-Whitney U-tests will be used to compare the intensity of each triplicate chemiluminescent spot of the CDI serum tested with the TcdA and TcdB standard curves, and to compare the intensities of the chemiluminescent spots of CDI patients with those of normal subjects. Quantitative variables will be expressed as the median and IQR.

According to ESCMID guidelines, our method will be compared with reference tests that are defined as the best tests currently available for CDI diagnosis (i.e., cell cytotoxicity neutralization assay (CCNA) and toxigenic culture (TC)). As both these reference tests detect different things, and because of this they will not necessarily agree with each other in all samples, results for each reference test will be analysed separately.

The performance of our method will be assessed using the receiver operating characteristic (ROC) curve and the area under the curve (AUC). The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the prediction rule of poor outcome will be calculated. Validity values will be calculated with a 95% CI following an exact binomial distribution. A P value <0.05 will be considered significant

Toxin kinetics (TcdA alone, TcdB alone, TcdA+TcdB) will be correlated by one-way analysis of variance (ANOVA) with CDI severity (defined according to ESCMID guidelines)

Toxin kinetics (TcdA alone, TcdB alone, TcdA+TcdB) will be correlated with the duration of diarrhea. A multivariate logistic regression model will be used. The odds ratio (OR) and 95% confidence interval (CI) will be calculated. The Spearman correlation coefficients and Wilcoxon rank sum tests will be used to determine whether TcdA and TcdB levels could be associated with the duration of diarrhea.

Toxin kinetics (TcdA alone, TcdB alone, TcdA+TcdB) will be correlated with the recurrence rate. A multivariate logistic regression model will be used to assess predictors of poor outcome of CDI. The odds ratio (OR) and 95% confidence interval (CI) will be calculated.
The Spearman correlation coefficients and Wilcoxon rank sum tests will be used to determine whether TcdA and TcdB levels could be associated with the recurrence rate.

Survival curves comparing the mortality with toxin(s) levels will be calculated using the Kaplan-Meier method and tested for significance using the log-rank test. P<0.05 will be considered statistically significant.

Roma Tre University

Merck Sharp & Dohme Corp.

Patients randomized to continue medical treatment with biologics

Patients randomized to stop medical treatment with biologics

Ulcerative Colitis in Remission

Ultrasound

Relapse/Recurrence

Transabdominal ultrasound of the bowel for categorisation of disease activity

Withdrawal of full blood at each study visit, Storage in biobank. Analysis of prouroguanyline and proguanyline.

Analysis of prouroguanyline and uroguanyline in full blood

Department of Medicine, Haukeland University Hospital

Ålesund Hospital

Predicting Relapse of Ulcerative Colitis With Gastrointestinal Ultrasound

Endscopic relapse defined as a MAYO endoscopic subscore ≥2

The clinical outcome for relapse is defined as a 6 point MAYO score ≥2.

Kappa statistics for inter-observer variation of patient classification into the relapse/no relapse categories and for categorical ultrasound parameters such as the ultrasound score (0-3), vascularity with colour Doppler (0-3), stratification of wall layers (0-3), presence of haustrations (0-1), presence of submucosal thickening (0-1), lymph nodes (0-2) and free fluid.

Bland Altman statistics of the continuous ultrasound parameter wall thickness (in mm).

Endscopic relapse defined as a MAYO endoscopic subscore ≥1

Relapse defined as presence of inflammation evaluated by pathologist in mucosal biopsies

spotted/diarreya

Relationship Between C. Difficile Toxins' Serum Level With C. Difficile Infection

Predicting Relapse of Ulcerative Colitis With Gastrointestinal Ultrasound

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