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Completed

NCT Number: NCT01797133

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

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.

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Key information

Conditions

All Hospitalzied Patients No Specific Conditions Requires

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Siriraj Hospital

Bangkok, 10700, Thailand

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ID fellow-based antibiotic pre-authorization

Procedure

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

Procedure

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.

Primary outcomes

  1. 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

    DDD of antibiotic use for that given infection (all antibiotics and controlled antibiotics)

Secondary outcomes

  1. 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

    Total duration of antibiotic use for that given infection (all antibiotics and controlled antibiotics)

Other outcomes

  1. 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)

    Clinial response (cure, improved, not improved, dead and refer) at the end of therapy and at discharge

Sponsors and collaborators

Lead sponsor

Siriraj Hospital

Other

Collaborators

  • Mahidol University

Registry information

Official study title

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

Acronym: DUE

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 22, 2013
Registry last updated
Feb 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.