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CompletedNCT03114358Updated Apr 19, 2017

Carbapenems De-escalation as Antimicrobial Stewardship

An interventional study of Early Carbapenem de-escalation in Anti-Bacterial Agents, sponsored by Chiang Mai University. Completed. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2017-04-19.

Sponsored by Chiang Mai University · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Jun 2016, registered Apr 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
104
Allocation
Randomized
Ages
15 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Anti-Bacterial Agents

Keywords

  • De-escalation
  • Carbapenems
  • Antimicrobial stewardship
03

In context

Lead sponsor

Chiang Mai University is the lead sponsor of 116 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion criteria

  • They were in the intensive care units, or had neutropenia (absolute neutrophil count \< 1,000 cell/mm3)
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
104 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherEarly 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).

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 24 hours

Secondary outcomes

  1. Mortality rate

    Compare the mortality rate between 2 groups

    Time frame: 90 days

  2. Readmission within 30 days,

    Compare the rate of readmission within 30 days between 2 groups

    Time frame: 30 days

  3. Costs of carbapenems

    Compare the cost of carbapenem prescription between 2 groups

    Time frame: 30 days

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03114358
Lead sponsor
Chiang Mai University
Responsible party
Romanee Chaiwarith (Associate professor, Chiang Mai University) — Principal investigator
First posted
Apr 14, 2017
Start date
Jun 1, 2016
Primary completion
Feb 28, 2017
Completion
Feb 28, 2017
Last update
Apr 19, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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