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Antimicrobial Stewardship Program for Clostridium Difficile Infection.
trial testing Systematic evaluation by an ID expert. in Clostridium Difficile in 403 participants. Completed in 15 December 2017.
| Lead sponsor | José María Aguado García, MD, PhD |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 403 |
| Start date | 15 February 2017 |
| Primary completion | 15 December 2017 |
| Estimated completion | 15 December 2017 |
| Sites | 1 location across Spain |
José María Aguado García, MD, PhD
Adults 18 to 110, any sex, with Clostridium Difficile or Enterocolitis, Pseudomembranous. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of patients with a Clostridium difficile infection recurrence in each group within the following 8 weeks after the end of specific treatment for the initial Clostridium difficile infection episode.
| Group | Value | 95% CI |
|---|---|---|
| Retrospective Historic Cohort. | 34 | |
| Intervention Group (Prospective) | 21 |
Number of patients in each group who suffer from at least one recurrence within the following 8 weeks after the end of specific treatment for the first recurrence of Clostridium difficile infection.
| Group | Value | 95% CI |
|---|---|---|
| Retrospective Historic Cohort. | 11 | |
| Intervention Group (Prospective) | 5 |
Our definition of right choice was judged according to the European Society of Clinical Microbiology and Infectious Diseases, 2013 and Clinical practice guidelines for Clostridium difficile infection in adults and children: 2017 update by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA). * Right choice: According to the current guidelines, the medication is effective for the condition an also used at optimal doses and duration, without duplication or association with unnecessary drugs. * Inappropriate/suboptimal prescription: Overuse:
| Group | Value | 95% CI |
|---|---|---|
| Retrospective Historic Cohort. | 149 | |
| Intervention Group (Prospective) | 130 |
Our definition of right choice of treatment was judged according to the European Society of Clinical Microbiology and Infectious Diseases, 2013 and Clinical practice guidelines for Clostridium difficile infection in adults and children: 2017 update by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA). Inappropriate/suboptimal prescription: Overuse: inclusion of unnecessary medication for the condition, which may result in an increased risk of adverse reactions, drug-drug interactions and increased costs.
| Group | Value | 95% CI |
|---|---|---|
| Retrospective Historic Cohort. | 40 | |
| Intervention Group (Prospective) | 10 |
Our definition of right choice was judged according to the European Society of Clinical Microbiology and Infectious Diseases, 2013 and Clinical practice guidelines for Clostridium difficile infection in adults and children: 2017 update by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA). Inappropriate/suboptimal prescription: Underuse: omission of a drug when there is a clear indication and no contraindications. The failure to prescribe essential medications may result in the worsening of the illness or therapeutic failure.
| Group | Value | 95% CI |
|---|---|---|
| Retrospective Historic Cohort. | 15 | |
| Intervention Group (Prospective) | 10 |
Percentage of patients with antibiotic treatments removed or adjusted as a result of the diagnosis of CDI.
| Group | Value | 95% CI |
|---|---|---|
| Retrospective Historic Cohort. | 62 | |
| Intervention Group (Prospective) | 33 |
Percentage of patients who die within 8 weeks of the Clostridium difficile infection diagnosis.
| Group | Value | 95% CI |
|---|---|---|
| Retrospective Historic Cohort. | 18 | |
| Intervention Group (Prospective) | 17 |
Percentage of patients who die within 30 days of the Clostridium difficile infection diagnosis. CDI-attributable mortality denotes the judgment by investigators that the patient would not have died within 30 days with the absence of CDI. Medical data were retrospectively reviewed by two independent investigators with clinical experience in CDI. In case of discrepancy, a third expert was consulted.
| Group | Value | 95% CI |
|---|---|---|
| Retrospective Historic Cohort. | 11 | |
| Intervention Group (Prospective) | 4 |
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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