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Completed

NCT Number: NCT03114358

Carbapenems De-escalation as Antimicrobial Stewardship

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

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Key information

Conditions

Anti-bacterial Agents

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Early Carbapenem de-escalation

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).

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Chiang Mai University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 14, 2017
Registry last updated
Apr 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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