NCT03114358

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 3, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 14, 2017

Completed
Last Updated

April 19, 2017

Status Verified

April 1, 2017

Enrollment Period

9 months

First QC Date

April 3, 2017

Last Update Submit

April 17, 2017

Conditions

Anti-Bacterial Agents

Keywords

De-escalationCarbapenemsAntimicrobial stewardship

Outcome Measures

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

    24 hours

Secondary Outcomes (3)

  • Mortality rate

    90 days

  • Readmission within 30 days,

    30 days

  • Costs of carbapenems

    30 days

Study Arms (2)

Early carbapenems de-escalation

EXPERIMENTAL

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

Late carbapenems de-escalation

NO INTERVENTION

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

Early Carbapenem de-escalationOTHER

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).

Early carbapenems de-escalation

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

April 3, 2017

First Posted

April 14, 2017

Study Start

June 1, 2016

Primary Completion

February 28, 2017

Study Completion

February 28, 2017

Last Updated

April 19, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share