Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Collaborators:
Hospital Universitario 12 de Octubre
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
José María Aguado García, MD, PhD, Hospital Universitario 12 de Octubre

Brief Summary:
The purpose of this study is to determine whether a bundle of measures specifically designed for patients with ICD and applied by and Infectious Diseases expert during a year period (2017) will improve the prognosis and reduce the rate of recurrence, compared with the baseline phase (2015) in which no intervention was made.

Condition or disease Intervention/treatment
Clostridium Difficile Enterocolitis, Pseudomembranous Behavioral: Systematic evaluation by an ID expert.

  Show Detailed Description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Group/Cohort Intervention/treatment
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:

  1. Systematic evaluation of all patients diagnosed with CDI 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 and to optimize concomitant antibiotic therapy ("antimicrobial stewardship").
  2. To ensure appropriate monitoring during the period of greatest risk of relapse in order to reduce as far as possible, the number of relapses. Personalized assistance by telephone or by email for early consultation in case of recurrence of symptoms or need for a new antibiotic course.

Retrospective historic cohort.
Patients diagnosed with CDI during 2015 in the University Hospital 12 de Octubre in which a systematic intervention was not done.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients diagnosed with CDI during 2015 in the University Hospital 12 de Octubre (retrospective historic cohort) or adult patients diagnosed with CDI during 2017 in the University Hospital 12 de Octubre (prospective cohort in which intervention was made).
Criteria

Inclusion Criteria:

  • Patients diagnosed with CDI in the University Hospital "12 de Octubre", Madrid, Spain, requiring hospitalization or emergency room admission longer than 48 hours, from the beginning of the study on (estimated start date: January 2017).
  • Patient or his/her representative sign the inform consent

Exclusion Criteria:

  • Patients younger than 18 years of age.
  • Patients with the diagnosis of inflammatory bowel disease.

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): NCT02951481


Contacts
Layout table for location contacts
Contact: Jose María Aguado, MD. PhD 0034913908000 ext 4843 jaguadog1@gmail.com
Contact: Julia Origüen, MD 0034913908000 ext 4632 josabater@hotmail.com

Locations
Layout table for location information
Spain
Unidad de Enfermedades Infecciosas. Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Contact: José María Aguado, MD.PhD.    0034913908000 ext 4843    jaguadog1@gmail.com   
Contact: Julia Origüen, MD    0034913908000 ext 4632    josabater@hotmail.com   
Sponsors and Collaborators
José María Aguado García, MD, PhD
Hospital Universitario 12 de Octubre
Merck Sharp & Dohme Corp.
Investigators
Layout table for investigator information
Principal Investigator: Jose María Aguado, MD. PhD University Hospital 12 de Octubre. Head of Infectious Disease Unit.

Publications:

Layout table for additonal information
Responsible Party: José María Aguado García, MD, PhD, Hospital Universitario 12 de Octubre
ClinicalTrials.gov Identifier: NCT02951481     History of Changes
Other Study ID Numbers: JMA-MET-2016-01
First Posted: November 1, 2016    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by José María Aguado García, MD, PhD, Hospital Universitario 12 de Octubre:
Clostridium difficile.
Antimicrobial Stewardship.
Enterocolitis, Pseudomembranous

Additional relevant MeSH terms:
Layout table for MeSH terms
Clostridium Infections
Enterocolitis
Enterocolitis, Pseudomembranous
Gram-Positive Bacterial Infections
Bacterial Infections
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Anti-Infective Agents
Anti-Bacterial Agents