Clostridioides Difficile Infection
Conditions
Keywords
Clostridioides difficile, Microbiome, Prediction, Unfavorable outcome
Brief summary
BEYOND is aiming to demonstrate how by enrichment of the available SPECIFY score, patients at great likelihood for CDI with unfavorable outcome are early detected
Detailed description
In a previous project, following GWAS analysis of the DNA and measurement of serum biomarkers coming from 134 patients a prediction score named SPECIFY was developed. The SPECIFY score comprises four elements: low hemoglobin, increased urea, increased IL-8 and carriage of G alleles of rs2091172. The score has 80% positive predictive value and 95.8% specificity for the early detection of unfavorable outcome but the sensitivity is low. Unfavorable outcome is defined as any of: presentation or progression into severe CDI, relapse; and death. Stool samples of day 1 before start of therapy of the patients are stored refrigerated. Microbiome analysis will be done aiming to the integration of the Shannon diversity index to the already developed score in order to improve sensitivity.
Interventions
DIAGNOSTIC_TESTMicrobiome analysis
Stool microbiome analysis of 16S rRNA sequencing to an anticipated number of 8,000,000 reads
Sponsors
Hellenic Institute for the Study of Sepsis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age more than or equal to 18 years * Both genders * Diarrhea defined as at least 3 episodes of unformed stools in the last 24hours according to the Bristol stool chart * Presence of C.difficile in stool. This is defined as any stool sample positive for the presence of glutamate dehydrogenase (GDH) and for the presence of toxin A and/or B.
Exclusion criteria
• No
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prediction of unfavorable outcome | 40 days | Sensitivity of the BEYOND score to predict unfavorable outcome of patients with infection by Clostridioides difficile |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic PCR reaction in stool | 40 days | Development of one RT-PCR reaction informing of the predominance of bacterial generum causing low microbiome diversity associated with the unfavorable outcome of CDI. |
Countries
Greece
Outcome results
None listed