SepsisNCT04755777
Provider Perspectives on Beta-lactam Therapeutic Drug Monitoring Programs in the Critically Ill
An observational study of Sepsis and Critical Illness, run by Mayo Clinic at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sepsis, Critical Illness
- How many people
- 138 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 22 Oct 2020to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Data will be obtained from ICU clinicians at three hospitals with distinct beta-lactam dosing and monitoring practices: Royal Brisbane and Women's Hospital in Queensland Australia, University of Florida Health Shands Hospital, Gainesville, Florida, United States, and the Mayo Clinic Hospital in Rochester, Minnesota, United States. The sampling frame will include key clinician stakeholders likely to be involved with beta-lactam TDM in the intensive care unit (i.e., pharmacists, intensivists, infectious diseases experts, medical/surgical trainees, and advanced practice providers).
Who may be able to join
- Providers involved with beta-lactam TDM for critically ill patients
Who cannot join
- None
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
UF Health Shands
Gainesville, Florida, 32610
Mayo Clinic
Rochester, Minnesota, 55902
Australia1 site
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029
About this study
Official title: Provider Perspectives on Beta-lactam Therapeutic Drug Monitoring Programs in the Critically Ill: a Multicenter Mixed-methods Study
The purpose of the study is to characterize various healthcare practitioners' perspectives on implementation of beta-lactam therapeutic drug monitoring in critical care practice.
- Conditions
- Sepsis, Critical Illness
- Keywords
- pharmacokinetics, therapeutic drug monitoring, mixed methods, implementation science, beta-lactam antibiotic
- Medical subject headings
- Sepsis, Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of drug level testing recommended
Indication of how many critically ill patients treated with beta-lactams should receive TDM.
Measured: Baseline
Nature of drug level testing recommended
Indication of which types of critically ill patients treated with beta-lactams should receive TDM
Measured: Baseline
Secondary outcomes (1)
Determinants of beta-lactam TDM implementation
List of factors associated with successful beta-lactam TDM implementation
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start22 Oct 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erin Barreto, Mayo Clinic
- Investigators
- Erin Barreto, Pharm. D.,R.Ph., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755777
- Sponsor's protocol ID
- 20-007528
- Status last verified
- Feb 2023
- First submitted
- 10 Feb 2021
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ausman S, Boehmer K, et al. Open Forum Infectious Diseases. 2022;9(Supplement 2):ofac492.034.
Barreto EF, Chitre PN, Pine KH, Shepel KK, Rule AD, Alshaer MH, Abdul Aziz MH, Roberts JA, Scheetz MH, Ausman SE, Moreland-Head LN, Rivera CG, Jannetto PJ, Mara KC, Boehmer KR. Why is the Implementation of Beta-Lactam Therapeutic Drug Monitoring for the Critically Ill Falling Short? A Multicenter Mixed-Methods Study. Ther Drug Monit. 2023 Aug 1;45(4):508-518. doi: 10.1097/FTD.0000000000001059. Epub 2023 Mar 21.
PubMed 37076424Barreto 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.
PubMed 33762025
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Provider Perspectives on Beta-lactam Therapeutic Drug Monitoring Programs in the Critically Ill: a Multicenter Mixed-methods Study
- ClinicalTrials.gov ID
- NCT04755777
- Acronym / sponsor ID
- 20-007528
- Conditions
- Sepsis, Critical Illness
- Keywords
- pharmacokinetics, therapeutic drug monitoring, mixed methods, implementation science, beta-lactam antibiotic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 16 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to characterize various healthcare practitioners' perspectives on implementation of beta-lactam therapeutic drug monitoring in critical care practice.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Data will be obtained from ICU clinicians at three hospitals with distinct beta-lactam dosing and monitoring practices: Royal Brisbane and Women's Hospital in Queensland Australia, University of Florida Health Shands Hospital, Gainesville, Florida, United States, and the Mayo Clinic Hospital in Rochester, Minnesota, United States. The sampling frame will include key clinician stakeholders likely to be involved with beta-lactam TDM in the intensive care unit (i.e., pharmacists, intensivists, infectious diseases experts, medical/surgical trainees, and advanced practice providers).
Key inclusion criteria (1 listed)
- Providers involved with beta-lactam TDM for critically ill patients
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of drug level testing recommended
Time frame: Baseline
Indication of how many critically ill patients treated with beta-lactams should receive TDM.
Nature of drug level testing recommended
Time frame: Baseline
Indication of which types of critically ill patients treated with beta-lactams should receive TDM
1 secondary outcome
Determinants of beta-lactam TDM implementation
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- BackgroundAusman S, Boehmer K, et al. Open Forum Infectious Diseases. 2022;9(Supplement 2):ofac492.034.
- Derived from this study: PubMed 37076424Barreto EF, Chitre PN, Pine KH, Shepel KK, Rule AD, Alshaer MH, Abdul Aziz MH, Roberts JA, Scheetz MH, Ausman SE, Moreland-Head LN, Rivera CG, Jannetto PJ, Mara KC, Boehmer KR. Why is the Implementation of Beta-Lactam Therapeutic Drug Monitoring for the Critically Ill Falling Short? A Multicenter Mixed-Methods Study. Ther Drug Monit. 2023 Aug 1;45(4):508-518. doi: 10.1097/FTD.0000000000001059. Epub 2023 Mar 21.
- Derived from this study: PubMed 33762025Barreto 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.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin Barreto, Pharm. D.,R.Ph. principal investigator
Mayo Clinic
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Critical Illness, run by Mayo Clinic at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of drug level testing recommended (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04755777, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.