NCT04187430

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
513

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2019

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 5, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

July 29, 2020

Status Verified

December 1, 2019

Enrollment Period

1.1 years

First QC Date

December 3, 2019

Last Update Submit

July 28, 2020

Conditions

Clostridium Difficile Infection

Outcome Measures

Primary Outcomes (1)

  • Create Score

    Create a high risk of recurrence score by reviewing a retrospective cohort of patients with DCI.

    31 december 2020

Study Arms (2)

Retrospective group

Behavioral: Retrospective

Prospective group

Behavioral: Prospective

Interventions

RetrospectiveBEHAVIORAL

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

Retrospective group
ProspectiveBEHAVIORAL

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

Prospective group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HGU Gregorio Maranon

Madrid, 28007, Spain

RECRUITING

MeSH Terms

Conditions

Clostridium Infections

Interventions

Retrospective StudiesLongitudinal Studies

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Case-Control StudiesEpidemiologic StudiesEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesCohort StudiesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Phd, MD Senior Assesor

Study Record Dates

First Submitted

December 3, 2019

First Posted

December 5, 2019

Study Start

December 1, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

July 29, 2020

Record last verified: 2019-12

Locations

ES(1)