C.Difficile DiarrheaNCT03964844
Clostridium Difficile Infection (CDI) in Hematologic Patients.
An observational study of C.Difficile Diarrhea, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
Trial summary
The microbiology department prospectively generates a data base of all episodes of Clostridium difficile infection (CDI) in the institution, the investigators will analyse the evolution of the episodes and the incidence per 10,000 days of stay of cases of diagnosed CDI in the Hematological wards and the rest of the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- C.Difficile Diarrhea
- How many people
- 450 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Based on data from our center, for the retrospective part of the study, the total number of hematological patients with CDI corresponding to the study period is approximately 200 patients, all of them will be studied, the sample size for controls will be of 200 patients (ratio 1:1). For the prospective study, also based in data from our center, approximately 50 patients will be enrolled.
Who may be able to join
- All patients diagnosed with a hematological disease who had a detection of toxigenic Clostridium difficile in the laboratory within the 2006-2018 period will be included in the study. Hematological patients with a negative CDI test in the same period will be included as controls.
- All patients diagnosed with an hematological/oncological disease or with any immunosuppressive condition, who have a positive detection of toxigenic Clostridium difficile in 2019.
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
Emilio Bouza, MD,PhD contact
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
Official title: Incidence, Clinical Characteristics, Strain Characterization, Treatment and Outcome of Clostridium Difficile Infection (CDI) in Hematologic Patients
The microbiology department prospectively generates a data base of all episodes of Clostridium difficile infection (CDI) in the institution, the investigators will analyse the evolution of the episodes and the incidence per 10,000 days of stay of cases of diagnosed CDI in the Hematological wards and the rest of the hospital during the 2006-2018 period. The investigators will also compare the impact on haematological paediatric population.
In order to analyse the clinical and epidemiological characteristics of CDI in this population, a case and control study will be conducted, reviewing the medical records of patients who have had an episode of diarrhoea caused by C. difficile in an hematological unit, which will be compared with non-hematological patients who have had an CDI episode These patients will be selected randomly from the Microbiology Department database. The sample size will be 400 patients, 200 per arm. The histories will be reviewed according to a pre-established clinical protocol including epidemiological, clinical, therapeutic and evolution variables.
A prospective study in 2019-2020 will also be conducted. The investigators will include all patients diagnosed with an hematological/oncological disease or with any immunosuppressive condition, who have a positive detection of toxigenic Clostridium difficile. Patients will be followed for at least 2 months. For each patient a protocol data will be filled prospectively.
Read the detailed description
A retrospective case control study (2006-2018) and a prospective study 2019-2020.
Study subjects
All patients diagnosed with a hematological disease who had a detection of toxigenic Clostridium difficile in the laboratory within the 2006-2018 period will be included in the study. Hematological patients with a negative Clostridium difficile infection (CDI) test in the same period will be included as controls, For controls, out of the number of cases within that study period, 200 will be randomly selected with the aid of the Excel software, with the tools randomization (RAND) and INDEX to ensure there is no bias. For each patient a protocol data will be filled retrospectively including the variables listed below.
Additionally, a prospective study in 2019-2020 will also be conducted. We will include all patients diagnosed with an hematological/oncological disease or with any immunosuppressive condition, who have a positive detection of toxigenic Clostridium difficile. Patients will be followed for at least 2 months. For each patient a protocol data will be filled prospectively including the variables listed below.
For all the study period 2006-2018 a total of approximately 200 patients will be included.
For the prospective study 2019-2020 approximately 50 patients will be included.Data collection
For the last 15 years, the institution has kept a prospective record of all episodes of CDI diagnosed in the hospital. This record enables the investigators to assess incidence, incidence density.
The data collected will include age, sex, hospital department or outpatient clinic diagnosis of CDI. Data regarding the underlying conditions and comorbidity factors, clinical data regarding the CDI episode days of diarrhea, presence of abdominal pain, abdominal distention, fever, hypotension, toxic megacolon, pseudomembranous colitis, and severity of the CDI episode according to the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) criteria. Analytical data on the day of diagnosis will be recorded. Treatment data will be recorded. Outcome will also recorded be recorded: need for intensive care unit (ICU) admission, need for surgery for CDI episode, recurrence, mortality, and CDI-associated mortality (For more details please find attached the clinical protocol).
The investigators will also assess all the changes regarding different procedures, management and treatments that have occurred during the study period, including all changes in the diagnostic procedures.
From January 2003 to February 2011, diagnosis of CDI was performed on all stool specimens for which a clinical request for C. difficile testing was made. From March 2011 to current days, diagnosis of CDI was also performed in all unformed stool specimens regardless of clinical request.
Laboratory procedure All C. difficile strains will be characterized at molecular level including ribotype, as it is the most widespread method for the molecular typing of Clostridium difficile. It is based on the detection of polymorphisms located in the intergenic region between genes 16S and 23S RNA by polymerase chain reaction (PCR) and electrophoresis on high resolution agarose gels and will be performed according to the technique described by Stubss et al.[13]The resulting ribotyping profiles will be compared to those of international libraries. Additionally antimicrobial susceptibility testing will be performed on these strains.
All analyses will be performed using SPSS 18.0 (SPSS Inc, Chicago, Illinois, USA). Qualitative variables will appear with their frequency distribution. Quantitative variables will be expressed as the median and interquartile range (IQR). Groups will be compared using the Fisher exact test for categorical variables and the t test or Mann-Whitney test for continuous variables. A multivariate logistic regression model will be used to assess predictors of poor outcome of CDI. The odds ratio (OR) and 95% confidence interval (CI) were calculated. A p value <0.05 will be considered significant.
Based on data from our center, for the retrospective part of the study, the total number of hematological patients with CDI corresponding to the study period is approximately 200 patients, all of them will be studied, the sample size for controls will be of 200 patients (ratio 1:1).
For the prospective study, also based in data from our center, approximately 50 patients will be enrolled.
- Conditions
- C.Difficile Diarrhea
- Being tested
- No intervention
- Keywords
- hematologic conditions, recurrence
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| CASE | Patients who had an episode of diarrhoea caused by C. difficile in an hematological unit (2003-2018) Receives: Other: No intervention | |
| CONTROL | Patients who have had an episode of diarrhoea not caused by C. difficile in an hematological unit (2003-2018) Receives: Other: No intervention | |
| PROSPECTIVE COHORT | All patients diagnosed with an hematological/oncological disease or with any immunosuppressive condition, who have a positive detection of toxigenic Clostridium difficile in 2019. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence
number of CDI cases/ 10,000 patient days
Measured: 2006-2020
Secondary outcomes (2)
Recurrence of CDI
The percentage of recurrent CDI episodes with respect of the total number of CDI cases
Measured: 2006-2020
Mortality attributable to CDI
Percentage of patients with CDI whose death is attributed to CDI
Measured: 2006-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start1 Jan 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 C.Difficile DiarrheaStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Gregorio Marañon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emilio Bouza, Hospital General Universitario Gregorio Marañon
- Investigators
- Elena Reigadas, PharmD, PhD, Principal investigator, Hospital General Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03964844
- Sponsor's protocol ID
- MICRO.HGUGM.2017-018
- Status last verified
- Jun 2020
- First submitted
- 23 May 2019
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- 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
- Incidence, Clinical Characteristics, Strain Characterization, Treatment and Outcome of Clostridium Difficile Infection (CDI) in Hematologic Patients
- ClinicalTrials.gov ID
- NCT03964844
- Acronym / sponsor ID
- MICRO.HGUGM.2017-018
- Conditions
- C.Difficile Diarrhea
- Keywords
- hematologic conditions, recurrence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Hospital General Universitario Gregorio MarañonUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 28 May 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 microbiology department prospectively generates a data base of all episodes of Clostridium difficile infection (CDI) in the institution, the investigators will analyse the evolution of the episodes and the incidence per 10,000 days of stay of cases of diagnosed CDI in the Hematological wards and the rest of the hospital during the 2006-2018 period. The investigators will also compare the impact on haematological paediatric population.
In order to analyse the clinical and epidemiological characteristics of CDI in this population, a case and control study will be conducted, reviewing the medical records of patients who have had an episode of diarrhoea caused by C. difficile in an hematological unit, which will be compared with non-hematological patients who have had an CDI episode These patients will be selected randomly from the Microbiology Department database. The sample size will be 400 patients, 200 per arm. The histories will be reviewed according to a pre-established clinical protocol including epidemiological, clinical, therapeutic and evolution variables.
A prospective study in 2019-2020 will also be conducted. The investigators will include all patients diagnosed with an hematological/oncological disease or with any immunosuppressive condition, who have a positive detection of toxigenic Clostridium difficile. Patients will be followed for at least 2 months. For each patient a protocol data will be filled prospectively.
Detailed description
A retrospective case control study (2006-2018) and a prospective study 2019-2020.
Study subjects
All patients diagnosed with a hematological disease who had a detection of toxigenic Clostridium difficile in the laboratory within the 2006-2018 period will be included in the study. Hematological patients with a negative Clostridium difficile infection (CDI) test in the same period will be included as controls, For controls, out of the number of cases within that study period, 200 will be randomly selected with the aid of the Excel software, with the tools randomization (RAND) and INDEX to ensure there is no bias. For each patient a protocol data will be filled retrospectively including the variables listed below.
Additionally, a prospective study in 2019-2020 will also be conducted. We will include all patients diagnosed with an hematological/oncological disease or with any immunosuppressive condition, who have a positive detection of toxigenic Clostridium difficile. Patients will be followed for at least 2 months. For each patient a protocol data will be filled prospectively including the variables listed below.
For all the study period 2006-2018 a total of approximately 200 patients will be included.
For the prospective study 2019-2020 approximately 50 patients will be included.Data collection
For the last 15 years, the institution has kept a prospective record of all episodes of CDI diagnosed in the hospital. This record enables the investigators to assess incidence, incidence density.
The data collected will include age, sex, hospital department or outpatient clinic diagnosis of CDI. Data regarding the underlying conditions and comorbidity factors, clinical data regarding the CDI episode days of diarrhea, presence of abdominal pain, abdominal distention, fever, hypotension, toxic megacolon, pseudomembranous colitis, and severity of the CDI episode according to the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) criteria. Analytical data on the day of diagnosis will be recorded. Treatment data will be recorded. Outcome will also recorded be recorded: need for intensive care unit (ICU) admission, need for surgery for CDI episode, recurrence, mortality, and CDI-associated mortality (For more details please find attached the clinical protocol).
The investigators will also assess all the changes regarding different procedures, management and treatments that have occurred during the study period, including all changes in the diagnostic procedures.
From January 2003 to February 2011, diagnosis of CDI was performed on all stool specimens for which a clinical request for C. difficile testing was made. From March 2011 to current days, diagnosis of CDI was also performed in all unformed stool specimens regardless of clinical request.
Laboratory procedure All C. difficile strains will be characterized at molecular level including ribotype, as it is the most widespread method for the molecular typing of Clostridium difficile. It is based on the detection of polymorphisms located in the intergenic region between genes 16S and 23S RNA by polymerase chain reaction (PCR) and electrophoresis on high resolution agarose gels and will be performed according to the technique described by Stubss et al.[13]The resulting ribotyping profiles will be compared to those of international libraries. Additionally antimicrobial susceptibility testing will be performed on these strains.
All analyses will be performed using SPSS 18.0 (SPSS Inc, Chicago, Illinois, USA). Qualitative variables will appear with their frequency distribution. Quantitative variables will be expressed as the median and interquartile range (IQR). Groups will be compared using the Fisher exact test for categorical variables and the t test or Mann-Whitney test for continuous variables. A multivariate logistic regression model will be used to assess predictors of poor outcome of CDI. The odds ratio (OR) and 95% confidence interval (CI) were calculated. A p value <0.05 will be considered significant.
Based on data from our center, for the retrospective part of the study, the total number of hematological patients with CDI corresponding to the study period is approximately 200 patients, all of them will be studied, the sample size for controls will be of 200 patients (ratio 1:1).
For the prospective study, also based in data from our center, approximately 50 patients will be enrolled.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CASE | – | Other: No interventionPatients who had an episode of diarrhoea caused by C. difficile in an hematological unit (2003-2018) |
| CONTROL | – | Other: No interventionPatients who have had an episode of diarrhoea not caused by C. difficile in an hematological unit (2003-2018) |
| PROSPECTIVE COHORT | – | Other: No interventionAll patients diagnosed with an hematological/oncological disease or with any immunosuppressive condition, who have a positive detection of toxigenic Clostridium difficile in 2019. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Based on data from our center, for the retrospective part of the study, the total number of hematological patients with CDI corresponding to the study period is approximately 200 patients, all of them will be studied, the sample size for controls will be of 200 patients (ratio 1:1). For the prospective study, also based in data from our center, approximately 50 patients will be enrolled.
Key inclusion criteria (2 listed)
- All patients diagnosed with a hematological disease who had a detection of toxigenic Clostridium difficile in the laboratory within the 2006-2018 period will be included in the study. Hematological patients with a negative CDI test in the same period will be included as controls.
- All patients diagnosed with an hematological/oncological disease or with any immunosuppressive condition, who have a positive detection of toxigenic Clostridium difficile in 2019.
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| No interventionNo intervention | Other | CASE, CONTROL, PROSPECTIVE COHORT |
Primary outcome
Incidence
Time frame: 2006-2020
number of CDI cases/ 10,000 patient days
2 secondary outcomes
Recurrence of CDI
Time frame: 2006-2020
Mortality attributable to CDI
Time frame: 2006-2020
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.
Emilio Bouza, MD,PhD contact
Elena Reigadas, PharmD, PhD principal investigator
Hospital General Universitario Gregorio Marañon
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 C.Difficile Diarrhea, run by Hospital General Universitario Gregorio Marañon 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?
Contact Elena Reigadas, PharmD, PhD (+34915868453, elena.reigadas@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence (time frame: 2006-2020). 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.