Trial record 20 of 2318 for:
Open Studies | "Anti-Bacterial Agents"
A Comparative Study of ID Fellow-based VS. Pharmacist-based Antibiotic Pre-authorization (DUE)
This study is currently recruiting participants.
Verified February 2013 by Siriraj Hospital
Sponsor:
Siriraj Hospital
Collaborator:
Mahidol University
Information provided by (Responsible Party):
Pinyo Rattanaumpawan, Siriraj Hospital
ClinicalTrials.gov Identifier:
NCT01797133
First received: February 17, 2013
Last updated: February 20, 2013
Last verified: February 2013
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Purpose
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 | Intervention |
|---|---|
|
All Hospitalzied Patients No Specific Conditions Requires |
Procedure: ID fellow-based antibiotic pre-authorization Procedure: Pharmacist-based antibiotic pre-authorization |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Siriraj Hospital:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]DDD of antibiotic use for that given infection (all antibiotics and controlled antibiotics)
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]Total duration of antibiotic use for that given infection (all antibiotics and controlled antibiotics)
Other Outcome Measures:
- 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) ] [ Designated as safety issue: Yes ]Clinial response (cure, improved, not improved, dead and refer) at the end of therapy and at discharge
| Estimated Enrollment: | 984 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Detailed Description:
Study design: A cluster randomized controlled trial Settings: 6 general medical wards at Siriraj Hospital, Bangkok, Thailand
Eligibility| Ages Eligible for Study: | 15 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01797133
Locations
| Thailand | |
| Siriraj Hospital | Recruiting |
| Bangkok, Thailand, 10700 | |
| Contact: Pinyo Rattanaumpawan, MD, MSCE 6624197783 pinyo.rat@mahidol.ac.th | |
| Principal Investigator: Pinyo Rattanaumpawan, MD, MSCE | |
Sponsors and Collaborators
Siriraj Hospital
Mahidol University
Investigators
| Principal Investigator: | Pinyo Rattanaumpawan, MD, MSCE | Mahidol University |
More Information
No publications provided
| Responsible Party: | Pinyo Rattanaumpawan, Asssitant Professor, Siriraj Hospital |
| ClinicalTrials.gov Identifier: | NCT01797133 History of Changes |
| Other Study ID Numbers: | 647/2555(EC1) |
| Study First Received: | February 17, 2013 |
| Last Updated: | February 20, 2013 |
| Health Authority: | Thailand: Ethical Committee |
Additional relevant MeSH terms:
|
Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013