NCT03025672

Brief Summary

Clostridium difficile is the first cause of nosocomial infectious diarrhea, due to its mode of transmission and its resistance in the environment. Nosocomiality is defined by the apparition of an infection 48 hours after the patient's hospitalization. Clostridium difficile contamination occurs oro-fecally and is transmitted directly through the hand or from the contaminated environment (during care or not). By implementing prevention and optimal treatment, nosocomial infections are preventable. A clostridium difficile infection causes an additional cost of patient care for the hospital. This additional cost is principally due to the increase of the length of the stay. It varies according to patient risk factors,and also according to the reason of the hospitalization and can vary from 300 euros (\~317$) to more than 25.000 euros (26.460$). By determining the increase in the length of the stay and the additional cost due to a clostridium difficile infection in the GHICL (Groupement des Hôpitaux de l'Institut Catholique de Lille), prevention will be valued and measures against those infections should be easier to set up. The main objective of this study is to evaluate the additional cost of an infection by clostridium difficile.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
10,445

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

Status
completed

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

April 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 19, 2017

Completed
Last Updated

January 19, 2017

Status Verified

January 1, 2017

Enrollment Period

1.8 years

First QC Date

January 10, 2017

Last Update Submit

January 16, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Difference between patient cost and income for the hospital based on the PMSI rate.

    The difference between the real cost of the patient stay, included the additional costs due to clostridium difficile infection, and the public funding (calculated using the PMSI) for this stay will be computed.

    Day 1

Study Arms (2)

clostridium difficile

Patients that have been infected by clostridium difficile during their stay in hospital

no clostridium difficile

Patients that have not been infected during their stay in hospital.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients that have stayed in an hospital of the GHICL in 2013 and 2014

You may qualify if:

  • Patients that have stayed in an hospital of the GHICL between January 2013 and September 2015.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cross InfectionClostridium Infections

Condition Hierarchy (Ancestors)

InfectionsIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and Mycoses

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2017

First Posted

January 19, 2017

Study Start

April 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

January 19, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share