Clostridium Difficile InfectionClostri_ScoreNCT04187430
Validation of a Prediction Score for Recurrent C. Difficile Infection: Implementation for Treatment Algorithm Strategies
An observational study of Clostridium Difficile Infection, run by Emilio Bouza at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Difficile Infection
- What is being tested?
- Retrospective and Prospective
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 513 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2019to 31 Dec 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Positive patients for C. difficile determined by the Microbiology Service of the General University Hospital Gregorio Marañón
Who may be able to join
- 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.
Who cannot join
- Children under 18 years or patients with <3 faeces not trained in the last 24 hours will not be included.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
HGU Gregorio Maranon
Madrid, 28007
Elena Reigadas, PhD, +34915868453, elena.reigadas@salud.madrid.org
Emilio Bouza, MDPhD, +34915868453, emilio.bouza@gmail.com
About this study
The objective of the present study is to derive a high-risk R-ICD prediction rule and a prospective implementation of this prediction rule.
Read the 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.
- Conditions
- Clostridium Difficile Infection
- Being tested
- Retrospective, Prospective
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RetrospectiveBehavioural
Those patients with a positive sample for ICD will be randomly selected from the microbiology database.
ProspectiveBehavioural
After the routine identification of a case of DCI by the microbiology laboratory, those new cases will be included in the study.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective group | Not described Receives: Behavioral: Retrospective | |
| Prospective group | Not described Receives: Behavioral: Prospective |
What is being measured
The primary outcome is the main question the study is designed to answer.
Create Score
Create a high risk of recurrence score by reviewing a retrospective cohort of patients with DCI.
Measured: 31 december 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start1 Dec 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium Difficile 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
- Other
- Enrolment
- 513 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emilio Bouza
- Sponsor type
- University, hospital or other
- Collaborators
- Elena Reigadas Ramirez, Patricia Muñoz García
- Responsible party
- Sponsor-investigator, Emilio Bouza, Hospital General Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04187430
- Sponsor's protocol ID
- MICRO.HGUGM.2019-016
- Acronym
- Clostri_Score
- Status last verified
- Dec 2019
- First submitted
- 3 Dec 2019
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Prediction Score for Recurrent C. Difficile Infection: Implementation for Treatment Algorithm Strategies
- ClinicalTrials.gov ID
- NCT04187430
- Acronym / sponsor ID
- Clostri_Score / MICRO.HGUGM.2019-016
- Conditions
- Clostridium Difficile Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 513 participants (estimated)
- Lead sponsor
- Emilio BouzaUniversity, hospital or other
- Collaborators
- Elena Reigadas Ramirez, Patricia Muñoz García
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 5 Dec 2019 (actual)
- 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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective group | – | Behavioral: Retrospective |
| Prospective group | – | Behavioral: Prospective |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Positive patients for C. difficile determined by the Microbiology Service of the General University Hospital Gregorio Marañón
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Children under 18 years or patients with <3 faeces not trained in the last 24 hours will not be included.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RetrospectiveThose patients with a positive sample for ICD will be randomly selected from the microbiology database. | Behavioural | Retrospective group |
| ProspectiveAfter the routine identification of a case of DCI by the microbiology laboratory, those new cases will be included in the study. | Behavioural | Prospective group |
Primary outcome
Create Score
Time frame: 31 december 2020
Create a high risk of recurrence score by reviewing a retrospective cohort of patients with DCI.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clostridium Difficile Infection, run by Emilio Bouza at 1 site in Spain.
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 2 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: status not confirmed, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Create Score (time frame: 31 december 2020). 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 29 Jul 2020.