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NCT04187430 Clinical Trial

Validation of a Prediction Score for Recurrent C. Difficile Infection: Implementation for Treatment Algorithm Strategies

Clostridium Difficile Infection Clinical Trial

— Clostri_Score  

Official title:
Validation of a Prediction Score for Recurrent C. Difficile Infection: Implementation for Treatment Algorithm Strategies

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04187430
Other study ID # MICRO.HGUGM.2019-016
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 1, 2019
Est. completion date December 31, 2020

Study information
Verified date December 2019
Source Hospital General Universitario Gregorio Marañon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The objective of the present study is to derive a high-risk R-ICD prediction rule and a prospective implementation of this prediction rule.

Description:

For objectives 1 and 2, a retrospective study of the microbiology database will be carried out and the medical records will be consulted to collect the variables included in Annex 2. The other prediction rules to be compared are those of Cobo et al., Reigadas et al and Gerding et al.

We will review a total of 215 patients according to the calculation of the sample size (see section) A prospective study will also be carried out in which the positive patients for C. difficile determined by the Microbiology Service of the General University Hospital Gregorio Marañón will be included. The medical records of the selected cases will be reviewed. All patients included in the prospective study (Objective 3) will receive the information sheet and consent sheet that they must sign for this study (Annex 1). These patients will be followed and the variables included in Annex 2 will be collected.

Recruitment information / eligibility
Status Recruiting
Enrollment 513
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- For the retrospective cohort, those patients with a positive sample for ICD will be randomly selected from the microbiology database.

- For the prospective cohort: after the routine identification of a case of DCI by the microbiology laboratory, those new cases will be included in the study.

Exclusion Criteria:

- Children under 18 years or patients with <3 faeces not trained in the last 24 hours will not be included.

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Retrospective
Those patients with a positive sample for ICD will be randomly selected from the microbiology database.
• Prospective
After the routine identification of a case of DCI by the microbiology laboratory, those new cases will be included in the study.

Locations
Country Name City State
Spain HGU Gregorio Maranon Madrid

Sponsors (3)
Lead Sponsor Collaborator
Emilio Bouza Elena Reigadas Ramirez, Patricia Muñoz García

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Create Score Create a high risk of recurrence score by reviewing a retrospective cohort of patients with DCI. 31 december 2020
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