Antimicrobial Stewardship Program for Clostridium Difficile Infection. (PACTA-ICD)
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02951481|
Recruitment Status : Unknown
Verified March 2017 by José María Aguado García, MD, PhD, Hospital Universitario 12 de Octubre.
Recruitment status was: Recruiting
First Posted : November 1, 2016
Last Update Posted : March 3, 2017
|Condition or disease||Intervention/treatment|
|Clostridium Difficile Enterocolitis, Pseudomembranous||Behavioral: Systematic evaluation by an ID expert.|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Antimicrobial Stewardship Program Based on the Detection and Monitoring of Patients With Clostridium Difficile Infection (PACTA-ICD)|
|Actual Study Start Date :||February 8, 2017|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||December 2018|
Systematic evaluation by an ID expert.
Patients diagnosed with CDI during 2017 in the University Hospital 12 de Octubre will be systematically evaluated by an Infectious Disease expert to ensure compliance with clinical practice guidelines about specific treatment for CDI, depending on the severity of the episode and the existence of previous episodes. This group of patients will also receive a close follow up during the period of greatest risk of relapse (8 weeks after completion of antibiotic treatment for CDI) in order to reduce as far as possible, the number of relapses.
Behavioral: Systematic evaluation by an ID expert.
Specific "bundle" of measures:
Retrospective historic cohort.
Patients diagnosed with CDI during 2015 in the University Hospital 12 de Octubre in which a systematic intervention was not done.
- Rate of Clostridium difficile infection recurrence. [ Time Frame: Within 8 weeks after the end of treatment. ]Number of recurrences in each group within the following 8 weeks after the end of specific treatment for the initial Clostridium difficile infection episode.
- Compliment with clinical practice guidelines for treatment of C. difficile infection. [ Time Frame: In the following 48 hours to the positive diagnostic result. ]Percentage of compliance with clinical practice guidelines (European Society of Clinical Microbiology and Infectious Diseases, 2013) for CDI treatment.
- Patients with antimicrobial adjustment. [ Time Frame: In the following 2 weeks to the positive diagnostic result. ]Percentage of patients with antibiotic treatments removed or adjusted as a result of the diagnosis of CDI.
- Early mortality rate. [ Time Frame: 72 hours after the positive diagnostic result. ]Percentage of patients who die within 72 hours of the Clostridium difficile infection diagnosis.
- Late mortality rate. [ Time Frame: 3 months after the positive diagnostic result. ]Percentage of patients who die within 3 months of the Clostridium difficile infection diagnosis.
Biospecimen Retention: Samples Without DNA
As patients with CDI are going to be prospectively followed, apart from the routine hematology and biochemistry analysis, serum immunoglobulin levels, serum complement levels (C3 and C4) and peripheral blood lymphocyte subpopulations will be measured at the end of CDI treatment.
The levels of these immunological parameters will be tested as markers for relapse by retrospectively comparing them between patients with and without recurrence.
A stool sample will be collected at the end of treatment to evaluate predictors of bad outcome or recurrence: Inflammatory markers (lactoferrin, calprotectin, IL-10) We will retrospectively compare these parameters between patients with and without recurrence.
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): NCT02951481
|Contact: Jose María Aguado, MD. PhD||0034913908000 ext email@example.com|
|Contact: Julia Origüen, MD||0034913908000 ext firstname.lastname@example.org|
|Unidad de Enfermedades Infecciosas. Hospital Universitario 12 de Octubre||Recruiting|
|Madrid, Spain, 28041|
|Contact: José María Aguado, MD.PhD. 0034913908000 ext 4843 email@example.com|
|Contact: Julia Origüen, MD 0034913908000 ext 4632 firstname.lastname@example.org|
|Principal Investigator:||Jose María Aguado, MD. PhD||University Hospital 12 de Octubre. Head of Infectious Disease Unit.|