Clinical Trial: Antimicrobial Stewardship Program for Clostridium Difficile Infection.

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Antimicrobial Stewardship Program Based on the Detection and Monitoring of Patients With Clostridium Difficile Infection (PACTA-ICD)

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.

Detailed Summary:

Patients with CDI benefit from the assessment and monitoring by an Infectious Diseases (ID) expert. Early intervention in patients diagnosed with a first episode of CDI would reduce the unnecessary use of antibiotics, improve prognosis by ensuring compliance with the clinical practice guidelines and reduce the number of recurrences.

Primary objective:

• To improve the prognosis of patients with CDI hospitalized during the period of intervention:

  • Increasing the compliance with clinical practice guidelines about specific treatment for CDI (for the episode that generated the intervention), depending on the severity of the episode and the existence of previous episodes
  • Reducing the recurrence rate by means of a close follow-up during the period of higher risk, avoiding factors that are known to predispose to recurrence.

Secondary objectives:

  • To discontinue or to reduce the spectrum of unnecessary antibiotic treatments in this population ("antimicrobial stewardship"), especially during the episode of CDI and during the following 8 weeks.
  • To discontinue inappropriate treatment of asymptomatic patients colonized by Clostridium difficile.
  • To identify clinical and biological markers that could be used as predictors of recurrence.
  • To identify patients with a high number of recurrences, that could benefit from novel or experimental treatments.

MATERIAL AND METHODS:

Number of recurrences in each group within the following 8 weeks after the end of specific treatment for the initial Clostridium difficile infection episode.



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: Hospital Universitario 12 de Octubre

Dates:
Date Received: October 28, 2016
Date Started: February 8, 2017
Date Completion: December 2018
Last Updated: March 2, 2017
Last Verified: March 2017