- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02768454
Antimicrobials Stewardship by Pharmacist
May 11, 2016 updated by: National Taiwan University Hospital
Appropriate Use of Controlled Broad-spectrum Antimicrobials by Establish Stewardship and Execute by Antibiotic Pharmacist
To study the outcome of antibiotics stewardship
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Retrospective cohort study by medical review and evaluation of broad-spectrum antibiotics to determine how appropriately it was bing used.
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Dou-Liou
-
Yun-Lin, Dou-Liou, Taiwan, test3
- National Taiwan University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
the investigators randomly do medical chart review of patients received broad-spectrum antibiotics from their hospital systems.
Description
inclusion criteria:
- Inpatient with infectious disease and under broad-spectrum antibiotics
exclusion criteria:
- Poor prognosis was diagnosed or received conservative therapy only.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
inpatient under broad-spectrum antibiotics
medical review
|
medical review of outcome of antibiotics stewardship by pharmacists and infectious disease physicians
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The percentage of appropriateness of empirical antibiotics choosing.
Time Frame: up to 8 weeks
|
For example,the inappropriate of piperacillin-tazobactam as empirical therapy was numbers of participants with no risk factors of deep tissue infection or DM foot /Number of participants treated with piperacillin-tazobactam for soft tissue infection.
|
up to 8 weeks
|
|
The percentage of appropriateness of de-escalation of therapy.
Time Frame: up to 8 weeks
|
For example,continued piperacillin-tazobactam was seen to be inappropriate when microbiologic results and clinical status permit de-escalation.
|
up to 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of adverse events of antibiotics were recorded.
Time Frame: up to 8 weeks
|
up to 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Shu-Chen Yang, master, National Taiwan University Hospital, Yun-Lin branch
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2015
Primary Completion (Anticipated)
September 1, 2016
Study Completion (Anticipated)
September 1, 2016
Study Registration Dates
First Submitted
February 11, 2016
First Submitted That Met QC Criteria
May 9, 2016
First Posted (Estimate)
May 11, 2016
Study Record Updates
Last Update Posted (Estimate)
May 13, 2016
Last Update Submitted That Met QC Criteria
May 11, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201511065RIND
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.