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Carbapenems De-escalation as Antimicrobial Stewardship

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03114358
Recruitment Status : Completed
First Posted : April 14, 2017
Last Update Posted : April 19, 2017
Sponsor:
Information provided by (Responsible Party):
Romanee Chaiwarith, Chiang Mai University

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

Condition or disease Intervention/treatment Phase
Anti-Bacterial Agents Other: Early Carbapenem de-escalation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Cluster Randomized Controlled Trial Comparing Early and Late Carbapenems De-escalation in the Medicine Units, Maharaj Nakorn Chiang Mai Hospital
Actual Study Start Date : June 1, 2016
Actual Primary Completion Date : February 28, 2017
Actual Study Completion Date : February 28, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: 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).
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).

No Intervention: 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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Mortality rate [ Time Frame: 90 days ]
    Compare the mortality rate between 2 groups

  2. Readmission within 30 days, [ Time Frame: 30 days ]
    Compare the rate of readmission within 30 days between 2 groups

  3. Costs of carbapenems [ Time Frame: 30 days ]
    Compare the cost of carbapenem prescription between 2 groups



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
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Responsible Party: Romanee Chaiwarith, Associate professor, Chiang Mai University
ClinicalTrials.gov Identifier: NCT03114358    
Other Study ID Numbers: 3629
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: April 19, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Romanee Chaiwarith, Chiang Mai University:
De-escalation
Carbapenems
Antimicrobial stewardship