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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04755777
Registration number
NCT04755777
Ethics application status
Date submitted
10/02/2021
Date registered
16/02/2021
Date last updated
21/02/2023
Titles & IDs
Public title
Provider Perspectives on Beta-lactam Therapeutic Drug Monitoring Programs in the Critically Ill
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Scientific title
Provider Perspectives on Beta-lactam Therapeutic Drug Monitoring Programs in the Critically Ill: a Multicenter Mixed-methods Study
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Secondary ID [1]
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20-007528
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Sepsis
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Critical Illness
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0
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Frequency of drug level testing recommended
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Assessment method [1]
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Indication of how many critically ill patients treated with beta-lactams should receive TDM.
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Timepoint [1]
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Baseline
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Primary outcome [2]
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Nature of drug level testing recommended
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Assessment method [2]
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Indication of which types of critically ill patients treated with beta-lactams should receive TDM
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Timepoint [2]
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Baseline
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Secondary outcome [1]
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Determinants of beta-lactam TDM implementation
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Assessment method [1]
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List of factors associated with successful beta-lactam TDM implementation
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Timepoint [1]
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Baseline
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Eligibility
Key inclusion criteria
* Providers involved with beta-lactam TDM for critically ill patients
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* None
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/10/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/12/2022
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Sample size
Target
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Accrual to date
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Final
138
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Royal Brisbane and Women's Hospital - Herston
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Recruitment postcode(s) [1]
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4029 - Herston
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Florida
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Country [2]
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United States of America
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State/province [2]
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Minnesota
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Funding & Sponsors
Primary sponsor type
Other
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Name
Mayo Clinic
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of the study is to characterize various healthcare practitioners' perspectives on implementation of beta-lactam therapeutic drug monitoring in critical care practice.
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Trial website
https://clinicaltrials.gov/study/NCT04755777
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Trial related presentations / publications
Ausman S, Boehmer K, et al. Open Forum Infectious Diseases. 2022;9(Supplement 2):ofac492.034. Barreto EF, Rule AD, Alshaer MH, Roberts JA, Abdul Aziz MH, Scheetz MH, Mara KC, Jannetto PJ, Gajic O, O'Horo JC, Boehmer KR. Provider perspectives on beta-lactam therapeutic drug monitoring programs in the critically ill: a protocol for a multicenter mixed-methods study. Implement Sci Commun. 2021 Mar 24;2(1):34. doi: 10.1186/s43058-021-00134-9.
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Public notes
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Contacts
Principal investigator
Name
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Erin Barreto, Pharm. D.,R.Ph.
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Address
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Mayo Clinic
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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0
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04755777
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