Trial Outcomes & Findings for Antimicrobial Stewardship Program for Clostridium Difficile Infection. (NCT NCT02951481)
NCT ID: NCT02951481
Last Updated: 2022-04-01
Results Overview
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.
COMPLETED
403 participants
Within 8 weeks after the end of treatment.
2022-04-01
Participant Flow
Retrospective period recruitment: 2015 (12 months). Prospective period: from February 15, 2017 to December 15, 2017 (10 months)
The initial idea was to include overall a minimun 200 patients (100 per group). As 231 patients fulfilled the criteria to be included in the retrospective arm, we finally recruited 172 patients during the prospective period (with a systematical intervention). Due to the study design, all started patients completed the study. So, counting the two groups, 403 patients started and completed the study. Neither the retrospective arm nor the prospective one suffered losses.
Participant milestones
| Measure |
Retrospective Historic Cohort
During 2015 (12 months), there were 231 patients with a first episode of CDI.
|
Prospective Group
Patients diagnosed with a first episode of 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 (1-February-2017). From February 15, 2017 to December 15, 2017 (10 months) there were 172 patients diagnosed with with a first episode of CDI.
|
|---|---|---|
|
Overall Study
STARTED
|
231
|
172
|
|
Overall Study
COMPLETED
|
231
|
172
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Retrospective Historic Cohort.
n=231 Participants
Patients diagnosed with CDI during 2015 in the University Hospital 12 de Octubre in which a systematic intervention was not done.
|
Intervention Group (Prospective)
n=172 Participants
Patients diagnosed with a first episode of 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 (1-February-2017). An intervention was made.
|
Total
n=403 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.26 years
STANDARD_DEVIATION 19.36 • n=231 Participants
|
64.73 years
STANDARD_DEVIATION 18.98 • n=172 Participants
|
64.46 years
STANDARD_DEVIATION 19.18 • n=403 Participants
|
|
Sex: Female, Male
Female
|
122 Participants
n=231 Participants
|
96 Participants
n=172 Participants
|
218 Participants
n=403 Participants
|
|
Sex: Female, Male
Male
|
109 Participants
n=231 Participants
|
76 Participants
n=172 Participants
|
185 Participants
n=403 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Spain
|
231 participants
n=231 Participants
|
172 participants
n=172 Participants
|
403 participants
n=403 Participants
|
|
Previous Comorbidities
Diabetes mellitus
|
37 Participants
n=231 Participants
|
38 Participants
n=172 Participants
|
75 Participants
n=403 Participants
|
|
Previous Comorbidities
Solid organ transplantation
|
21 Participants
n=231 Participants
|
32 Participants
n=172 Participants
|
53 Participants
n=403 Participants
|
|
Previous Comorbidities
Chronic renal failure
|
41 Participants
n=231 Participants
|
42 Participants
n=172 Participants
|
83 Participants
n=403 Participants
|
|
Previous Comorbidities
Any immunocompromising condition
|
70 Participants
n=231 Participants
|
48 Participants
n=172 Participants
|
118 Participants
n=403 Participants
|
|
Previous Comorbidities
Inflammatory bowel disease
|
17 Participants
n=231 Participants
|
9 Participants
n=172 Participants
|
26 Participants
n=403 Participants
|
PRIMARY outcome
Timeframe: Within 8 weeks after the end of treatment.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.
Outcome measures
| Measure |
Retrospective Historic Cohort.
n=231 Participants
Patients diagnosed with CDI during 2015 in the University Hospital 12 de Octubre in which a systematic intervention was not done.
|
Intervention Group (Prospective)
n=172 Participants
Patients diagnosed with a first episode of 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 (1-February-2017). An intervention was made.
|
|---|---|---|
|
Number of Participants With Clostridium Difficile Infection Recurrence.
|
34 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: 8 weeks after the end of specific treatment for the first recurrence of Clostridium difficile infection.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.
Outcome measures
| Measure |
Retrospective Historic Cohort.
n=231 Participants
Patients diagnosed with CDI during 2015 in the University Hospital 12 de Octubre in which a systematic intervention was not done.
|
Intervention Group (Prospective)
n=172 Participants
Patients diagnosed with a first episode of 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 (1-February-2017). An intervention was made.
|
|---|---|---|
|
Number of Participants Experiencing More Than One Clostridium Difficile Infection Recurrence.
|
11 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: In the following 48 hours to the positive diagnostic result.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: inclusion of unnecessary medication for the condition, which may result in an increased risk of adverse reactions, drug-drug interactions and increased costs. 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.
Outcome measures
| Measure |
Retrospective Historic Cohort.
n=231 Participants
Patients diagnosed with CDI during 2015 in the University Hospital 12 de Octubre in which a systematic intervention was not done.
|
Intervention Group (Prospective)
n=172 Participants
Patients diagnosed with a first episode of 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 (1-February-2017). An intervention was made.
|
|---|---|---|
|
Number of Participants With The Right Choice Anti-Clostridium Difficile Infection Treatment (According to the Current Guidelines for Treatment of C. Difficile Infection).
|
149 Participants
|
130 Participants
|
SECONDARY outcome
Timeframe: In the following 48 hours to the positive diagnostic result.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.
Outcome measures
| Measure |
Retrospective Historic Cohort.
n=231 Participants
Patients diagnosed with CDI during 2015 in the University Hospital 12 de Octubre in which a systematic intervention was not done.
|
Intervention Group (Prospective)
n=172 Participants
Patients diagnosed with a first episode of 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 (1-February-2017). An intervention was made.
|
|---|---|---|
|
Number of Participants With a Clostridium Difficile Infection That Received an Inappropriate Prescription by Overuse.
|
40 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: In the following 48 hours to the positive diagnostic result.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.
Outcome measures
| Measure |
Retrospective Historic Cohort.
n=231 Participants
Patients diagnosed with CDI during 2015 in the University Hospital 12 de Octubre in which a systematic intervention was not done.
|
Intervention Group (Prospective)
n=172 Participants
Patients diagnosed with a first episode of 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 (1-February-2017). An intervention was made.
|
|---|---|---|
|
Number of Participants With a Clostridium Difficile Infection That Received an Inappropriate Prescription by Underuse.
|
15 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Retrospective Historic Cohort.
n=231 Participants
Patients diagnosed with CDI during 2015 in the University Hospital 12 de Octubre in which a systematic intervention was not done.
|
Intervention Group (Prospective)
n=172 Participants
Patients diagnosed with a first episode of 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 (1-February-2017). An intervention was made.
|
|---|---|---|
|
Number of Participants With Antimicrobial Adjustment.
|
62 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: 8 weeks after the positive diagnostic result.Percentage of patients who die within 8 weeks of the Clostridium difficile infection diagnosis.
Outcome measures
| Measure |
Retrospective Historic Cohort.
n=231 Participants
Patients diagnosed with CDI during 2015 in the University Hospital 12 de Octubre in which a systematic intervention was not done.
|
Intervention Group (Prospective)
n=172 Participants
Patients diagnosed with a first episode of 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 (1-February-2017). An intervention was made.
|
|---|---|---|
|
All Cause Mortality
|
18 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 30 days after the positive diagnostic result.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.
Outcome measures
| Measure |
Retrospective Historic Cohort.
n=231 Participants
Patients diagnosed with CDI during 2015 in the University Hospital 12 de Octubre in which a systematic intervention was not done.
|
Intervention Group (Prospective)
n=172 Participants
Patients diagnosed with a first episode of 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 (1-February-2017). An intervention was made.
|
|---|---|---|
|
Clostridium Difficile Infection Attributable Mortality Rate.
|
11 Participants
|
4 Participants
|
Adverse Events
Retrospective Historic Cohort.
Intervention Group (Prospective)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
MD, PhD José María Aguado García
Fundación de investigación Hospital Universitario 12 de Octubre
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place