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

July 28, 2020 updated by: Emilio Bouza
The objective of the present study is to derive a high-risk R-ICD prediction rule and a prospective implementation of this prediction rule.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

513

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Positive patients for C. difficile determined by the Microbiology Service of the General University Hospital Gregorio Marañón

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Other

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Create Score
Time Frame: 31 december 2020
Create a high risk of recurrence score by reviewing a retrospective cohort of patients with DCI.
31 december 2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emilio Bouza

Collaborators

Elena Reigadas Ramirez
Patricia Muñoz García

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2019

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

December 3, 2019

First Submitted That Met QC Criteria

December 3, 2019

First Posted (Actual)

December 5, 2019

Study Record Updates

Last Update Posted (Actual)

July 29, 2020

Last Update Submitted That Met QC Criteria

July 28, 2020

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MICRO.HGUGM.2019-016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Clostridium Difficile Infection

Clinical Trials on Retrospective

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe