Carbapenems De-escalation as Antimicrobial Stewardship

NCT ID: NCT03114358

Last Updated: 2017-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-01
• Study Completion Date: 2017-02-28

Brief Summary

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.

Conditions

Anti-Bacterial Agents

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Early carbapenems de-escalation

De-escalation carbapenems within 24 hours or no later than 72 hours of prescription by Infectious disease specialist (early de-escalation).

Group Type: EXPERIMENTAL

Early Carbapenem de-escalation

Intervention Type: OTHER

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).

Late carbapenems de-escalation

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chiang Mai University

OTHER

Sponsor Role: lead

Responsible Party

Romanee Chaiwarith

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

3629

Identifier Type: -

Identifier Source: org_study_id