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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01797133
First Posted: February 22, 2013
Last Update Posted: February 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Mahidol University
Information provided by (Responsible Party):
Pinyo Rattanaumpawan, Siriraj Hospital
  Purpose
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.

Condition Intervention
All Hospitalzied Patients No Specific Conditions Requires Procedure: ID fellow-based antibiotic pre-authorization Procedure: Pharmacist-based antibiotic pre-authorization

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparative Study of ID Fellow-based Pre-authorization VS. Pharmacist-based Pre-authorization in Reducing Antibiotic Consumptions and Hospital Expenditures

Resource links provided by NLM:


Further study details as provided by Pinyo Rattanaumpawan, Siriraj Hospital:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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)


Other Outcome Measures:
  • 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


Estimated Enrollment: 984
Study Start Date: February 2013
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01797133


Locations
Thailand
Siriraj Hospital
Bangkok, Thailand, 10700
Sponsors and Collaborators
Siriraj Hospital
Mahidol University
Investigators
Principal Investigator: Pinyo Rattanaumpawan, MD, MSCE Mahidol University
  More Information

Responsible Party: Pinyo Rattanaumpawan, Asssitant Professor, Siriraj Hospital
ClinicalTrials.gov Identifier: NCT01797133     History of Changes
Other Study ID Numbers: 647/2555(EC1)
First Submitted: February 17, 2013
First Posted: February 22, 2013
Last Update Posted: February 22, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Anti-Bacterial Agents
Piperacillin, tazobactam drug combination
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action