A Comparative Study of ID Fellow-based VS. Pharmacist-based Antibiotic Pre-authorization (DUE)

February 19, 2016 updated by: Pinyo Rattanaumpawan, Siriraj Hospital

A Comparative Study of ID Fellow-based Pre-authorization VS. Pharmacist-based Pre-authorization in Reducing Antibiotic Consumptions and Hospital Expenditures

We will conduct a cluster randomized controlled trial to compare two antibiotic pre-authorization strategies (Fellow-based vs. Pharmacist-based). We believe that amount and duration of antibiotic consumption would be lower in the pharmacist group while the clinical outcome would be equivalent between two groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study design: A cluster randomized controlled trial Settings: 6 general medical wards at Siriraj Hospital, Bangkok, Thailand

Study Type

Interventional

Enrollment (Anticipated)

984

Phase

  • Not Applicable

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

  • Thailand
      • Bangkok, Thailand, 10700
        • Siriraj 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

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hospitalized patients
  • Received at least one dose of controlled antibiotics (Piperacillin/Tazobactam, Imipenem/Cilastatin, Meropenem or Doripenem)
  • Each patient may be enrolled more than once, if he/she receives the controlled antibiotic for a new episode of infection (at least 48 hour apart)

Exclusion Criteria:

  • Died prior to receive the controlled antibiotic

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fellow arm
Patients in this arm will receive the ID fellow-based antibiotic pre-authorization intervention.
Procedure: ID fellow-based antibiotic pre-authorization
All prescriptions of controlled antibiotics (Piperacillin/Tazobactam, Imipenem/Cilastatin, Meropenem and Doripenem) can be freely prescribed for the first 72 hours. After that, the prescription requires approval. Antibiotic preauthorization program will be operated by ID-fellows, under the supervision of ID staffs.
Active Comparator: Pharmacist arm
Patients in this arm will receive the pharmacist-based antibiotic pre-authorization intervention.
Procedure: Pharmacist-based antibiotic pre-authorization
All prescriptions of controlled antibiotics (Piperacillin/Tazobactam, Imipenem/Cilastatin, Meropenem and Doripenem) can be freely prescribed for the first 72 hours. After that, the prescription requires approval. Antibiotic preauthorization program will be operated by general pharmacists, under the supervision of ID staffs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Defined Daily Dose (DDD) of antibiotics
Time Frame: Participants will be followed for the total duration of antibiotic therapy for that given infection, an expected average of 2 weeks
DDD of antibiotic use for that given infection (all antibiotics and controlled antibiotics)
Participants will be followed for the total duration of antibiotic therapy for that given infection, an expected average of 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total duration of antibiotic use
Time Frame: Participants will be followed for the total duration of antibiotic therapy for that given infection, an expected average of 2 weeks
Total duration of antibiotic use for that given infection (all antibiotics and controlled antibiotics)
Participants will be followed for the total duration of antibiotic therapy for that given infection, an expected average of 2 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical response
Time Frame: at the end of therapy and at discharge (an average duration of antibiotic therapy is 2 weeks, an average length of stay is 3 weeks)
Clinial response (cure, improved, not improved, dead and refer) at the end of therapy and at discharge
at the end of therapy and at discharge (an average duration of antibiotic therapy is 2 weeks, an average length of stay is 3 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Siriraj Hospital

Collaborators

Mahidol University

Investigators

  • Principal Investigator: Pinyo Rattanaumpawan, MD, MSCE, Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

February 17, 2013

First Submitted That Met QC Criteria

February 20, 2013

First Posted (Estimate)

February 22, 2013

Study Record Updates

Last Update Posted (Estimate)

February 22, 2016

Last Update Submitted That Met QC Criteria

February 19, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 647/2555(EC1)

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.

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