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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04187430

Acronym

Clostri_Score

Enrollment

513

Registered

2019-12-05

Start date

2019-12-01

Completion date

2020-12-31

Last updated

2020-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clostridium Difficile Infection

Brief 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.

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.

Interventions

BEHAVIORALRetrospective

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

BEHAVIORALProspective

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

Study design

Observational model

CASE_CONTROL

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026