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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Siriraj Hospital
Sponsor:
Collaborator:
Mahidol University
Information provided by (Responsible Party):
Pinyo Rattanaumpawan, Siriraj Hospital
ClinicalTrials.gov Identifier:
NCT01797133
First received: February 17, 2013
Last updated: February 20, 2013
Last verified: February 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: Yes ]
    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
Estimated Study Completion Date: December 2013
Estimated 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

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01797133

Locations
Thailand
Siriraj Hospital Recruiting
Bangkok, Thailand, 10700
Contact: Pinyo Rattanaumpawan, MD, MSCE    6624197783    pinyo.rat@mahidol.ac.th   
Principal Investigator: Pinyo Rattanaumpawan, MD, MSCE         
Sponsors and Collaborators
Siriraj Hospital
Mahidol University
Investigators
Principal Investigator: Pinyo Rattanaumpawan, MD, MSCE Mahidol University
  More Information

No publications provided

Responsible Party: Pinyo Rattanaumpawan, Asssitant Professor, Siriraj Hospital
ClinicalTrials.gov Identifier: NCT01797133     History of Changes
Other Study ID Numbers: 647/2555(EC1)
Study First Received: February 17, 2013
Last Updated: February 20, 2013
Health Authority: Thailand: Ethical Committee

Additional relevant MeSH terms:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on August 26, 2014