NCT02768454

Brief Summary

To study the outcome of antibiotics stewardship

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 11, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

May 13, 2016

Status Verified

May 1, 2016

Enrollment Period

1 year

First QC Date

February 11, 2016

Last Update Submit

May 11, 2016

Conditions

Infection

Keywords

broad-spectrum antimicrobialantibiotics pharmacist

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    up to 8 weeks

Secondary Outcomes (1)

  • Number of adverse events of antibiotics were recorded.

    up to 8 weeks

Study Arms (1)

inpatient under broad-spectrum antibiotics

medical review

Drug: medical review of controlled broad-spectrum antibiotics

Interventions

medical review of controlled broad-spectrum antibioticsDRUG

medical review of outcome of antibiotics stewardship by pharmacists and infectious disease physicians

inpatient under broad-spectrum antibiotics

Eligibility Criteria

Age20 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

the investigators randomly do medical chart review of patients received broad-spectrum antibiotics from their hospital systems.

You may qualify if:

  • Inpatient with infectious disease and under broad-spectrum antibiotics

You may not qualify if:

  • Poor prognosis was diagnosed or received conservative therapy only.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Douliu, Dou-Liou, test3, Taiwan

Location

MeSH Terms

Conditions

Infections

Study Officials

  • Shu-Chen Yang, master

    National Taiwan University Hospital, Yun-Lin Branch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2016

First Posted

May 11, 2016

Study Start

September 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

May 13, 2016

Record last verified: 2016-05

Locations

TW(1)