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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

513 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-01

Study Completion Date

2020-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Clostridium Difficile Infection

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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Retrospective group

Retrospective

Intervention Type BEHAVIORAL

Those patients with a positive sample for ICD will be randomly selected from the microbiology database.

Prospective group

Prospective

Intervention Type BEHAVIORAL

After the routine identification of a case of DCI by the microbiology laboratory, those new cases will be included in the study.

Interventions

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Retrospective

Those patients with a positive sample for ICD will be randomly selected from the microbiology database.

Intervention Type BEHAVIORAL

Prospective

After the routine identification of a case of DCI by the microbiology laboratory, those new cases will be included in the study.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.