N/A
Completed N=403
Antimicrobial Stewardship Program for Clostridium Difficile Infection.
Clostridium Difficile · Enterocolitis, Pseudomembranous
Source: ClinicalTrials.gov NCT02951481 ↗
Enrolled (actual)
403
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcomePrimary: Number of Participants With Clostridium Difficile Infection Recurrence. — 34; 21 Participants — p=0.56
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clostridium Difficile Infection Recurrence. |
34; 21 | 0.56 |
| SECONDARY Number of Participants Experiencing More Than One Clostridium Difficile Infection Recurrence. |
11; 5 | 0.55 |
| SECONDARY Number of Participants With The Right Choice Anti-Clostridium Difficile Infection Treatment (According to the Current Guidelines for Treatment of C. Difficile Infection). |
149; 130 | 0.023 sig |
| SECONDARY Number of Participants With a Clostridium Difficile Infection That Received an Inappropriate Prescription by Overuse. |
40; 10 | <0.001 sig |
| SECONDARY Number of Participants With a Clostridium Difficile Infection That Received an Inappropriate Prescription by Underuse. |
15; 10 | 0.5 |
| SECONDARY Number of Participants With Antimicrobial Adjustment. |
62; 33 | 0.07 |
| SECONDARY All Cause Mortality |
18; 17 | 0.47 |
| SECONDARY Clostridium Difficile Infection Attributable Mortality Rate. |
11; 4 | 0.29 |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02951481). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.