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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01797133

Acronym

DUE

Enrollment

984

Registered

2013-02-22

Start date

2013-02-28

Completion date

2013-12-31

Last updated

2016-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

All Hospitalzied Patients, No Specific Conditions Requires

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

Interventions

PROCEDUREID 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.

PROCEDUREPharmacist-based antibiotic pre-authorization

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026