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

All Hospitalzied Patients Clinical Trial

— DUE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01797133
• Other study ID #: 647/2555(EC1)
• Status: Completed
• Phase: N/A
• First received: February 17, 2013
• Last updated: February 19, 2016
• Start date: February 2013
• Est. completion date: December 2013

Study information

• Verified date: February 2016
• Source: Siriraj Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 984
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• All Hospitalzied Patients
• No Specific Conditions Requires

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.
• 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.

Locations

Country	Name	City	State
Thailand	Siriraj Hospital	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Siriraj Hospital	Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical response	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)	Yes
Primary	Defined Daily Dose (DDD) of antibiotics	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	No
Secondary	Total duration of antibiotic use	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	No