All Hospitalzied PatientsDUENCT01797133
A Comparative Study of ID Fellow-based VS. Pharmacist-based Antibiotic Pre-authorization
A study testing ID fellow-based antibiotic pre-authorization and Pharmacist-based antibiotic pre-authorization in people with All Hospitalzied Patients and No Specific Conditions Requires, run by Siriraj Hospital at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- All Hospitalzied Patients, No Specific Conditions Requires
- What is being tested?
- ID fellow-based antibiotic pre-authorization and Pharmacist-based antibiotic pre-authorization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 984 participants
- Where
- 1 siteThailand
- Study dates
- Feb 2013to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Died prior to receive the controlled antibiotic
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study of ID Fellow-based Pre-authorization VS. Pharmacist-based Pre-authorization in Reducing Antibiotic Consumptions and Hospital Expenditures
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.
Read the detailed description
Study design: A cluster randomized controlled trial Settings: 6 general medical wards at Siriraj Hospital, Bangkok, Thailand
- Being tested
- ID fellow-based antibiotic pre-authorization, Pharmacist-based antibiotic pre-authorization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ID fellow-based antibiotic pre-authorizationProcedure or surgery
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-authorizationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Fellow arm | Active comparator | Patients in this arm will receive the ID fellow-based antibiotic pre-authorization intervention. Receives: Procedure: ID fellow-based antibiotic pre-authorization |
| Pharmacist arm | Active comparator | Patients in this arm will receive the pharmacist-based antibiotic pre-authorization intervention. Receives: Procedure: Pharmacist-based antibiotic pre-authorization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Defined Daily Dose (DDD) of antibiotics
DDD of antibiotic use for that given infection (all antibiotics and controlled antibiotics)
Measured: Participants will be followed for the total duration of antibiotic therapy for that given infection, an expected average of 2 weeks
Secondary outcomes (1)
Total duration of antibiotic use
Total duration of antibiotic use for that given infection (all antibiotics and controlled antibiotics)
Measured: Participants will be followed for the total duration of antibiotic therapy for that given infection, an expected average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for All Hospitalzied PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 984 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mahidol University
- Responsible party
- Principal investigator, Pinyo Rattanaumpawan, Siriraj Hospital
- Investigators
- Pinyo Rattanaumpawan, MD, MSCE, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01797133
- Sponsor's protocol ID
- 647/2555(EC1)
- Acronym
- DUE
- Status last verified
- Feb 2016
- First submitted
- 17 Feb 2013
- Last updated
- 22 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rattanaumpawan P, Upapan P, Thamlikitkul V. A noninferiority cluster-randomized controlled trial on antibiotic postprescription review and authorization by trained general pharmacists and infectious disease clinical fellows. Infect Control Hosp Epidemiol. 2018 Oct;39(10):1154-1162. doi: 10.1017/ice.2018.198. Epub 2018 Aug 29.
PubMed 30156171
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of ID Fellow-based Pre-authorization VS. Pharmacist-based Pre-authorization in Reducing Antibiotic Consumptions and Hospital Expenditures
- ClinicalTrials.gov ID
- NCT01797133
- Acronym / sponsor ID
- DUE / 647/2555(EC1)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 984 participants (estimated)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Collaborators
- Mahidol University
- Study start
- Feb 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 22 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fellow arm | Active comparator | Procedure: ID fellow-based antibiotic pre-authorizationPatients in this arm will receive the ID fellow-based antibiotic pre-authorization intervention. |
| Pharmacist arm | Active comparator | Procedure: Pharmacist-based antibiotic pre-authorizationPatients in this arm will receive the pharmacist-based antibiotic pre-authorization intervention. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- Died prior to receive the controlled antibiotic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ID fellow-based antibiotic pre-authorizationAll 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. | Procedure or surgery | Fellow arm |
| Pharmacist-based antibiotic pre-authorizationAll 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. | Procedure or surgery | Pharmacist arm |
Primary outcome
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)
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2016.
- Derived from this study: PubMed 30156171Rattanaumpawan P, Upapan P, Thamlikitkul V. A noninferiority cluster-randomized controlled trial on antibiotic postprescription review and authorization by trained general pharmacists and infectious disease clinical fellows. Infect Control Hosp Epidemiol. 2018 Oct;39(10):1154-1162. doi: 10.1017/ice.2018.198. Epub 2018 Aug 29.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pinyo Rattanaumpawan, MD, MSCE principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ID fellow-based antibiotic pre-authorization and Pharmacist-based antibiotic pre-authorization in people with All Hospitalzied Patients and No Specific Conditions Requires, run by Siriraj Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01797133, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2016.