Cross InfectionNCT03025672
Evaluation of the Cost of a Nosocomial Infection With Clostridium Difficile
An observational study of Cross Infection and Clostridium Difficile Infection, run by Lille Catholic University.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cross Infection, Clostridium Difficile Infection
- How many people
- 10,445 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients that have stayed in an hospital of the GHICL in 2013 and 2014
Who may be able to join
- Patients that have stayed in an hospital of the GHICL between January 2013 and September 2015.
Who cannot join
- none
About this study
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.
Read more
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.
- Conditions
- Cross Infection, Clostridium Difficile Infection
- Medical subject headings
- Cross Infection, Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2017 (estimated)
- Study startApr 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cross InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 10,445 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03025672
- Sponsor's protocol ID
- OBS-021
- Status last verified
- Jan 2017
- First submitted
- 10 Jan 2017
- Last updated
- 19 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Cost of a Nosocomial Infection With Clostridium Difficile
- ClinicalTrials.gov ID
- NCT03025672
- Acronym / sponsor ID
- OBS-021
- Conditions
- Cross Infection, Clostridium Difficile Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,445 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 19 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients that have stayed in an hospital of the GHICL in 2013 and 2014
Key inclusion criteria (1 listed)
- Patients that have stayed in an hospital of the GHICL between January 2013 and September 2015.
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference between patient cost and income for the hospital based on the PMSI rate.
Time frame: Day 1
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cross Infection and Clostridium Difficile Infection, run by Lille Catholic University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between patient cost and income for the hospital based on the PMSI rate. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2017.