Carbapenems De-escalation as Antimicrobial Stewardship

Study Overview
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Brief Summary
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Early de-escalation of carbapenems can reduce unnecessary use of carbaepenems compared with late de-escalation without compromised clinical outcomes

Detailed Description
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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.

Official Title
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A Cluster Randomized Controlled Trial Comparing Early and Late Carbapenems De-escalation in the Medicine Units, Maharaj Nakorn Chiang Mai Hospital

Conditions
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Anti-Bacterial Agents

Intervention / Treatment
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* Other: Early Carbapenem de-escalation


Participation Criteria
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Eligibility Criteria
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Inclusion criteria 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 Exclusion criteria They were in the intensive care units, or had neutropenia (absolute neutrophil count < 1,000 cell/mm3)

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early carbapenems de-escalation<br>De-escalation carbapenems within 24 hours or no later than 72 hours of prescription by Infectious disease specialist (early de-escalation). | Other: Early Carbapenem de-escalation<br>* 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).<br>|
| No Intervention: Late carbapenems de-escalation<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate | Compare the mortality rate between 2 groups | 90 days | 
| Readmission within 30 days, | Compare the rate of readmission within 30 days between 2 groups | 30 days | 
| Costs of carbapenems | Compare the cost of carbapenem prescription between 2 groups | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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De-escalation, Carbapenems, Antimicrobial stewardship