Anti-Bacterial AgentsNCT03114358
Carbapenems De-escalation as Antimicrobial Stewardship
A study testing Early Carbapenem de-escalation in people with Anti-Bacterial Agents, run by Chiang Mai University.
Trial summary
Early de-escalation of carbapenems can reduce unnecessary use of carbaepenems compared with late de-escalation without compromised clinical outcomes Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Anti-Bacterial Agents
- What is being tested?
- Early Carbapenem de-escalation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to 28 Feb 2017
- 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
- All adult patients aged ≥ 15 years old
- received carbapenems (meropenem and imipenem/cilastatin) empirically within 24-72 hours for the first time during admission
- able to sign informed consent
Who cannot join
- They were in the intensive care units, or had neutropenia (absolute neutrophil count < 1,000 cell/mm3)
About this study
Official title: A Cluster Randomized Controlled Trial Comparing Early and Late Carbapenems De-escalation in the Medicine Units, Maharaj Nakorn Chiang Mai Hospital
Early de-escalation of carbapenems can reduce unnecessary use of carbaepenems compared with late de-escalation without compromised clinical outcomes
Read the detailed description
A cluster randomized control trial was conducted among patients receiving care at the medicine units of the Maharaj Nakorn Chiang Mai Hospital.
Patients were randomly assigned into 2 groups. The standard group followed the hospital policy in which carbapenems were evaluated by ID specialist at 72 hours of admission (late de-escalation). De-escalation may occurred earlier depends upon the decision of the primary care team. The intervention group is de-escalation carbapenems early within 24 hours or no later than 72 hours of prescription by ID specialist (early de-escalation).
Clinical outcomes included rate of de-escalation within the first 24 hour, the mortality rate, and other clinical outcomes.
- Conditions
- Anti-Bacterial Agents
- Being tested
- Early Carbapenem de-escalation
- Keywords
- De-escalation, Carbapenems, Antimicrobial stewardship
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Carbapenem de-escalationOther
The intervention group is de-escalation carbapenems early within 24 hours or no later than 72 hours of prescription by ID specialist (early de-escalation).
| Study group | Role | What they receive |
|---|---|---|
| Early carbapenems de-escalation | Experimental | De-escalation carbapenems within 24 hours or no later than 72 hours of prescription by Infectious disease specialist (early de-escalation). Receives: Other: Early Carbapenem de-escalation |
| Late carbapenems de-escalation | No intervention | De-escalation followed the hospital policy in which carbapenems were evaluated by ID specialist at 72 hours of admission (late de-escalation). De-escalation may occurred earlier depends upon the decision of the primary care team |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of de-escalation within the first 24 hour
Compare the rate of de-escalation within the first 24 hour between arm 1 and arm 2
Measured: 24 hours
Secondary outcomes (3)
Mortality rate
Compare the mortality rate between 2 groups
Measured: 90 days
Readmission within 30 days,
Compare the rate of readmission within 30 days between 2 groups
Measured: 30 days
Costs of carbapenems
Compare the cost of carbapenem prescription between 2 groups
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start1 Jun 2016
- Primary completion28 Feb 2017
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anti-Bacterial AgentsStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Romanee Chaiwarith, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03114358
- Sponsor's protocol ID
- 3629
- Status last verified
- Apr 2017
- First submitted
- 3 Apr 2017
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomized Controlled Trial Comparing Early and Late Carbapenems De-escalation in the Medicine Units, Maharaj Nakorn Chiang Mai Hospital
- ClinicalTrials.gov ID
- NCT03114358
- Acronym / sponsor ID
- 3629
- Conditions
- Anti-Bacterial Agents
- Keywords
- De-escalation, Carbapenems, Antimicrobial stewardship
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 14 Apr 2017 (actual)
- 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.
Early de-escalation of carbapenems can reduce unnecessary use of carbaepenems compared with late de-escalation without compromised clinical outcomes
Detailed description
A cluster randomized control trial was conducted among patients receiving care at the medicine units of the Maharaj Nakorn Chiang Mai Hospital.
Patients were randomly assigned into 2 groups. The standard group followed the hospital policy in which carbapenems were evaluated by ID specialist at 72 hours of admission (late de-escalation). De-escalation may occurred earlier depends upon the decision of the primary care team. The intervention group is de-escalation carbapenems early within 24 hours or no later than 72 hours of prescription by ID specialist (early de-escalation).
Clinical outcomes included rate of de-escalation within the first 24 hour, the mortality rate, and other clinical outcomes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early carbapenems de-escalation | Experimental | Other: Early Carbapenem de-escalationDe-escalation carbapenems within 24 hours or no later than 72 hours of prescription by Infectious disease specialist (early de-escalation). |
| Late carbapenems de-escalation | No intervention | –De-escalation followed the hospital policy in which carbapenems were evaluated by ID specialist at 72 hours of admission (late de-escalation). De-escalation may occurred earlier depends upon the decision of the primary care team |
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)
- All adult patients aged ≥ 15 years old
- received carbapenems (meropenem and imipenem/cilastatin) empirically within 24-72 hours for the first time during admission
- able to sign informed consent
Key exclusion criteria (1 listed)
- They were in the intensive care units, or had neutropenia (absolute neutrophil count < 1,000 cell/mm3)
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 |
|---|---|---|
| Early Carbapenem de-escalationThe intervention group is de-escalation carbapenems early within 24 hours or no later than 72 hours of prescription by ID specialist (early de-escalation). | Other | Early carbapenems de-escalation |
Primary outcome
The rate of de-escalation within the first 24 hour
Time frame: 24 hours
Compare the rate of de-escalation within the first 24 hour between arm 1 and arm 2
3 secondary outcomes
Mortality rate
Time frame: 90 days
Readmission within 30 days,
Time frame: 30 days
Costs of carbapenems
Time frame: 30 days
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 19 Apr 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Early Carbapenem de-escalation in people with Anti-Bacterial Agents, run by Chiang Mai University.
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 19 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The rate of de-escalation within the first 24 hour (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2017.