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

Not Applicable

Completed

• Conditions: All Hospitalzied Patients; No Specific Conditions Requires
• Interventions: Procedure: ID fellow-based antibiotic pre-authorization; Procedure: Pharmacist-based antibiotic pre-authorization

• Registration Number: NCT01797133
• Lead Sponsor: Siriraj Hospital

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-17
• Study First Submitted QC: 2013-02-20
• Study First Posted: 2013-02-22
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-19
• Last Update Posted: 2016-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 984

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fellow arm	ID fellow-based antibiotic pre-authorization	Patients in this arm will receive the ID fellow-based antibiotic pre-authorization intervention.
Pharmacist arm	Pharmacist-based antibiotic pre-authorization	Patients in this arm will receive the pharmacist-based antibiotic pre-authorization intervention.

Primary Outcome Measures

Name	Time	Method
Defined Daily Dose (DDD) of antibiotics	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

Name	Time	Method
Total duration of antibiotic use	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)

Trial Locations

Locations (1)

Siriraj Hospital; 🇹🇭 Bangkok, Thailand