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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
Scientific title
Provider Perspectives on Beta-lactam Therapeutic Drug Monitoring Programs in the Critically Ill: a Multicenter Mixed-methods Study
Secondary ID [1] 0 0
20-007528
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sepsis 0 0
Critical Illness 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Frequency of drug level testing recommended
Timepoint [1] 0 0
Baseline
Primary outcome [2] 0 0
Nature of drug level testing recommended
Timepoint [2] 0 0
Baseline
Secondary outcome [1] 0 0
Determinants of beta-lactam TDM implementation
Timepoint [1] 0 0
Baseline

Eligibility
Key inclusion criteria
* Providers involved with beta-lactam TDM for critically ill patients
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* None

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/12/2022
Sample size
Target
Accrual to date
Final
138
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Minnesota

Funding & Sponsors
Primary sponsor type
Other
Name
Mayo Clinic
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT04755777
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.
Public notes

Contacts
Principal investigator
Name 0 0
Erin Barreto, Pharm. D.,R.Ph.
Address 0 0
Mayo Clinic
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04755777