InfectionNCT02768454
Antimicrobials Stewardship by Pharmacist
An observational study of Infection, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
To study the outcome of antibiotics stewardship Read more about this study
- Who is it for?
- Ages 20 to 99 years
- Conditions the study is for
- Infection
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2015to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: the investigators randomly do medical chart review of patients received broad-spectrum antibiotics from their hospital systems.
Who may be able to join
- Inpatient with infectious disease and under broad-spectrum antibiotics
Who cannot join
- Poor prognosis was diagnosed or received conservative therapy only.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Appropriate Use of Controlled Broad-spectrum Antimicrobials by Establish Stewardship and Execute by Antibiotic Pharmacist
To study the outcome of antibiotics stewardship
Read the detailed description
Retrospective cohort study by medical review and evaluation of broad-spectrum antibiotics to determine how appropriately it was bing used.
- Conditions
- Infection
- Being tested
- medical review of controlled broad-spectrum antibiotics
- Keywords
- broad-spectrum antimicrobial, antibiotics pharmacist
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical review of controlled broad-spectrum antibioticsDrug
medical review of outcome of antibiotics stewardship by pharmacists and infectious disease physicians
| Study group | Role | What they receive |
|---|---|---|
| inpatient under broad-spectrum antibiotics | medical review Receives: Drug: medical review of controlled broad-spectrum antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of appropriateness of empirical antibiotics choosing.
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.
Measured: up to 8 weeks
The percentage of appropriateness of de-escalation of therapy.
For example,continued piperacillin-tazobactam was seen to be inappropriate when microbiologic results and clinical status permit de-escalation.
Measured: up to 8 weeks
Secondary outcomes (1)
Number of adverse events of antibiotics were recorded.
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startSep 2015
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shu-Chen Yang, master, Principal investigator, National Taiwan University Hospital, Yun-Lin Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02768454
- Sponsor's protocol ID
- 201511065RIND
- Status last verified
- May 2016
- First submitted
- 11 Feb 2016
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appropriate Use of Controlled Broad-spectrum Antimicrobials by Establish Stewardship and Execute by Antibiotic Pharmacist
- ClinicalTrials.gov ID
- NCT02768454
- Acronym / sponsor ID
- 201511065RIND
- Conditions
- Infection
- Keywords
- broad-spectrum antimicrobial, antibiotics pharmacist
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 11 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study the outcome of antibiotics stewardship
Detailed description
Retrospective cohort study by medical review and evaluation of broad-spectrum antibiotics to determine how appropriately it was bing used.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| inpatient under broad-spectrum antibiotics | – | Drug: medical review of controlled broad-spectrum antibioticsmedical review |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the investigators randomly do medical chart review of patients received broad-spectrum antibiotics from their hospital systems.
Key inclusion criteria (1 listed)
- Inpatient with infectious disease and under broad-spectrum antibiotics
Key exclusion criteria (1 listed)
- Poor prognosis was diagnosed or received conservative therapy only.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| medical review of controlled broad-spectrum antibioticsmedical review of outcome of antibiotics stewardship by pharmacists and infectious disease physicians | Drug | inpatient under broad-spectrum antibiotics |
Primary outcome
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.
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.
1 secondary outcome
Number of adverse events of antibiotics were recorded.
Time frame: up to 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shu-Chen Yang, master principal investigator
National Taiwan University Hospital, Yun-Lin Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of appropriateness of empirical antibiotics choosing. (time frame: up to 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2016.