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

• Sponsor: Siriraj Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01797133
• Collaborator: Mahidol University (Other)
• Enrollment: 984
• Location: 1
• Arms: 2
• Duration (Months): 10
• Patients Per Site Per Month: 98.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
All Hospitalzied Patients; No Specific Conditions Requires	Procedure: ID fellow-based antibiotic pre-authorization; Procedure: Pharmacist-based antibiotic pre-authorization	N/A

Detailed Description

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 984 participants
• 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
• Study Start Date: Feb 1, 2013
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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)

Other Outcome Measures

1. Clinical response [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Siriraj Hospital	Bangkok		Thailand	10700

Sponsors and Collaborators

• Siriraj Hospital
• Mahidol University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pinyo Rattanaumpawan, Asssitant Professor, Siriraj Hospital
• ClinicalTrials.gov Identifier: NCT01797133
• Other Study ID Numbers: 647/2555(EC1)
• First Posted: Feb 22, 2013
• Last Update Posted: Feb 22, 2016
• Last Verified: Feb 1, 2016

• Additional relevant MeSH terms: Anti-Bacterial Agents; Antibiotics, Antitubercular

Study Results

No Results Posted as of Feb 22, 2016