Carbapenems De-escalation as Antimicrobial Stewardship

Anti-Bacterial Agents Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03114358
• Other study ID #: 3629
• Status: Completed
• Phase: N/A
• First received: April 3, 2017
• Last updated: April 17, 2017
• Start date: June 1, 2016
• Est. completion date: February 28, 2017

Study information

• Verified date: April 2017
• Source: Chiang Mai University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: February 28, 2017
• Est. primary completion date: February 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anti-Bacterial Agents

Intervention

Other:
• Early Carbapenem de-escalation
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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chiang Mai University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mortality rate	Compare the mortality rate between 2 groups	90 days
Secondary	Readmission within 30 days,	Compare the rate of readmission within 30 days between 2 groups	30 days
Secondary	Costs of carbapenems	Compare the cost of carbapenem prescription between 2 groups	30 days