MedTrace Logo

Clostridium Difficile Infection (CDI) in Hematologic Patients.

NCT03964844 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 450

Last updated 2020-07-29

No results posted yet for this study

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.

Conditions

  • C.Difficile Diarrhea

Interventions

OTHER

No intervention

No intervention

Sponsors & Collaborators

  • Hospital General Universitario Gregorio Marañon

    lead OTHER

Principal Investigators

  • Elena Reigadas, PharmD, PhD · Hospital General Universitario Gregorio Marañón

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03964844 on ClinicalTrials.gov