Clostridium Difficile Infection (CDI) in Hematologic Patients.
Incidence, Clinical Characteristics, Strain Characterization, Treatment and Outcome of Clostridium Difficile Infection (CDI) in Hematologic Patients
1 other identifier
observational
450
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2019
1 active site
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
January 1, 2019
CompletedFirst Submitted
Initial submission to the registry
May 23, 2019
CompletedFirst Posted
Study publicly available on registry
May 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedJuly 29, 2020
June 1, 2020
2 years
May 23, 2019
July 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence
number of CDI cases/ 10,000 patient days
2006-2020
Secondary Outcomes (2)
Recurrence of CDI
2006-2020
Mortality attributable to CDI
2006-2020
Study Arms (3)
CASE
Patients who had an episode of diarrhoea caused by C. difficile in an hematological unit (2003-2018)
CONTROL
Patients who have had an episode of diarrhoea not caused by C. difficile in an hematological unit (2003-2018)
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.
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- N/A
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
HGU Gregorio Maranon
Madrid, 28007, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elena Reigadas, PharmD, PhD
Hospital General Universitario Gregorio Marañón
Central Study Contacts
Emilio Bouza, MD,PhD
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
May 23, 2019
First Posted
May 28, 2019
Study Start
January 1, 2019
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
July 29, 2020
Record last verified: 2020-06