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Clostridium Difficile Infection (CDI) in Hematologic Patients.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03964844
Recruitment Status : Recruiting
First Posted : May 28, 2019
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
Emilio Bouza, Hospital General Universitario Gregorio Marañon

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.


Condition or disease Intervention/treatment
C.Difficile Diarrhea Other: No intervention

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Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Other
Time Perspective: Other
Official Title: Incidence, Clinical Characteristics, Strain Characterization, Treatment and Outcome of Clostridium Difficile Infection (CDI) in Hematologic Patients
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Group/Cohort Intervention/treatment
CASE
Patients who had an episode of diarrhoea caused by C. difficile in an hematological unit (2003-2018)
Other: No intervention
No intervention

CONTROL
Patients who have had an episode of diarrhoea not caused by C. difficile in an hematological unit (2003-2018)
Other: No intervention
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.
Other: No intervention
No intervention




Primary Outcome Measures :
  1. Incidence [ Time Frame: 2006-2020 ]
    number of CDI cases/ 10,000 patient days


Secondary Outcome Measures :
  1. Recurrence of CDI [ Time Frame: 2006-2020 ]
    The percentage of recurrent CDI episodes with respect of the total number of CDI cases

  2. Mortality attributable to CDI [ Time Frame: 2006-2020 ]
    Percentage of patients with CDI whose death is attributed to CDI



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • N/A

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03964844


Contacts
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Contact: Elena Reigadas, PharmD, PhD +34915868453 elena.reigadas@salud.madrid.org
Contact: Emilio Bouza, MD,PhD

Locations
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Spain
HGU Gregorio Maranon Recruiting
Madrid, Spain, 28007
Contact: Elena Reigadas, PhD    +34915868453    elena.reigadas@salud.madrid.org   
Contact: Emilio Bouza, MDPhD    +34915868453    emilio.bouza@gmail.com   
Principal Investigator: Elena Reigadas, PhD         
Sponsors and Collaborators
Hospital General Universitario Gregorio Marañon
Investigators
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Principal Investigator: Elena Reigadas, PharmD, PhD Hospital General Universitario Gregorio Marañón
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Responsible Party: Emilio Bouza, Clinical Professor, Hospital General Universitario Gregorio Marañon
ClinicalTrials.gov Identifier: NCT03964844    
Other Study ID Numbers: MICRO.HGUGM.2017-018
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Emilio Bouza, Hospital General Universitario Gregorio Marañon:
hematologic conditions
recurrence
Additional relevant MeSH terms:
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Clostridium Infections
Diarrhea
Signs and Symptoms, Digestive
Gram-Positive Bacterial Infections
Bacterial Infections