SepsisNCT07287332
BLOOM: Pragmatic Feasibility Trial
A study testing Up-front individualized dosing algorithm in people with Sepsis and Infection, run by Mayo Clinic at 1 site in United States.
Trial summary
The goal of this study is to compare two different ways of dosing cefepime, an antibiotic for very sick patients - the usual approach to dosing or a new dosing method. The new dosing method uses only doses that are available in normal care, but choosing between the different doses is based on more information about… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Up-front individualized dosing algorithm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥18 years of age
- Admitted to one of the ICUs at the study center
- Prescribed cefepime therapy by the care team
Who cannot join
- Individuals will be those with a cephalosporin allergy
- Received >1 dose of cefepime in the 24 hours before ICU admission
- Transferred from an external hospital without compatible EHR
- Does not have a cystatin C and a creatinine available for drug dosing
- Acute kidney injury stage 2 or higher
- Receiving renal replacement therapy
Show all 11Show fewer
- Treated with extracorporeal membrane oxygenation
- Undergoing molecular adsorbent recirculating therapy at the time of beta-lactam initiation
- Pregnant
- Incarcerated
- Declined Minnesota research authorization
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Gerald W. Flaby Jr., LRT, RRT, 507-422-3462, flaby.gerald@mayo.edu
About this study
The goal of this study is to compare two different ways of dosing cefepime, an antibiotic for very sick patients - the usual approach to dosing or a new dosing method. The new dosing method uses only doses that are available in normal care, but choosing between the different doses is based on more information about the patient's body including their kidney function. The primary purpose of this study is to test how easy it is for healthcare professionals to use the new dosing method and how best to conduct the trial. The study will also assess if the new dosing method helps patients recover faster and reduces side effects.
- Being tested
- Up-front individualized dosing algorithm, Usual Care
- Keywords
- Beta-lactam antibiotics, Sepsis, Septic shock, Pharmacokinetics, Personalized medicine, Therapeutic drug monitoring, Infectious disease
- Medical subject headings
- Sepsis, Infections, Shock, Septic, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Up-front individualized dosing algorithmOther
An individualized cefepime dosing algorithm will be used to determine the cefepime dose and interval. The dose recommendation will be provided using the EHR-prompts to the clinical care team and ordered and/or verified by the ICU pharmacist using an established collaborative practice agreement. As a pragmatic trial, at any point care teams may modify the empiric or subsequent dose based on their clinical judgement.
Usual CareOther
The standard of care group will receive empiric dosing guided by an institutional antimicrobial guide. Cefepime is typically dosed at 0.5-2 g every 8-24 h according to categorical thresholds of estimated creatinine clearance (eGFRcr). Cystatin C and eGFRcr-cys can be calculated and used at clinicians' discretion to aid in drug dose determination.
| Study group | Role | What they receive |
|---|---|---|
| Up-front individualized dosing algorithm | Experimental | Clinical decision support to encourage use of an individualized cefepime dosing algorithm based on eGFRcr-cysC and weight. Receives: Other: Up-front individualized dosing algorithm |
| Usual Care | Active comparator | The standard of care group will receive empiric dosing of cefepime, using an institutional antimicrobial guide based on four categories of eGFRcr. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients screened who qualified for the study
Number of patients who quality for the study out of total number of patients screened, reported as a percentage
Measured: 1 year or once the sample size is achieved
Distribution of qualified patients across care teams
Number of patients from each ICU care team who qualify for the study
Measured: 1 year or once the sample size is achieved
Adherence to dosing recommendations
Total number of patients randomized to the up-front individualized dosing algorithm who are prescribed the algorithm's recommended dosage
Measured: 1 year or once the sample size is achieved
Secondary outcomes (6)
Number of antibiotic-free days
Number of antibiotic-free days for the first 28 days
Measured: 28-days
ICU length of stay
Number of days of initial ICU stay
Measured: 1 year
Proportion of patients who experience new anti-Pseudomonal beta-lactam resistance
New anti-Pseudomonal beta-lactam resistance which develops within the 6 months following initial treatment
Measured: 6 months
Proportion of patients who experience clinical success
Complete or partial resolution of clinical signs and symptoms attributed to infection across 8 days of therapy.
Measured: 8 days
Proportion of patients who experience microbiologic success
Presumed or documented eradication of causative microorganisms
Measured: 8 days
Mortality
All cause death
Measured: 28-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start15 Jan 2026
- Primary completionMar 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erin Barreto, Mayo Clinic
- Investigators
- Erin Barreto, PharmD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07287332
- Sponsor's protocol ID
- 25-004564
- Status last verified
- Feb 2026
- First submitted
- 20 Nov 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barreto EF, Scheetz MH, Chang J, Cole KC, Fogelson LA, Paul J, Jannetto PJ, Gajic O, Rule AD; Beta Lactam Optimization and Outcomes Management (BLOOM) Study Group. Cystatin C-Guided Dosing Nomogram Improves Target Attainment for Cefepime in the Critically Ill. Crit Care Med. 2025 Apr 1;53(4):e941-e952. doi: 10.1097/CCM.0000000000006622. Epub 2025 Feb 27.
PubMed 40013864
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BLOOM: Pragmatic Feasibility Trial
- ClinicalTrials.gov ID
- NCT07287332
- Acronym / sponsor ID
- 25-004564
- Keywords
- Beta-lactam antibiotics, Sepsis, Septic shock, Pharmacokinetics, Personalized medicine, Therapeutic drug monitoring, Infectious disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 17 Dec 2025 (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 goal of this study is to compare two different ways of dosing cefepime, an antibiotic for very sick patients - the usual approach to dosing or a new dosing method. The new dosing method uses only doses that are available in normal care, but choosing between the different doses is based on more information about the patient's body including their kidney function. The primary purpose of this study is to test how easy it is for healthcare professionals to use the new dosing method and how best to conduct the trial. The study will also assess if the new dosing method helps patients recover faster and reduces side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Up-front individualized dosing algorithm | Experimental | Other: Up-front individualized dosing algorithmClinical decision support to encourage use of an individualized cefepime dosing algorithm based on eGFRcr-cysC and weight. |
| Usual Care | Active comparator | Other: Usual CareThe standard of care group will receive empiric dosing of cefepime, using an institutional antimicrobial guide based on four categories of eGFRcr. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults ≥18 years of age
- Admitted to one of the ICUs at the study center
- Prescribed cefepime therapy by the care team
Key exclusion criteria (11 listed)
- Individuals will be those with a cephalosporin allergy
- Received >1 dose of cefepime in the 24 hours before ICU admission
- Transferred from an external hospital without compatible EHR
- Does not have a cystatin C and a creatinine available for drug dosing
- Acute kidney injury stage 2 or higher
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Up-front individualized dosing algorithmAn individualized cefepime dosing algorithm will be used to determine the cefepime dose and interval. The dose recommendation will be provided using the EHR-prompts to the clinical care team and ordered and/or verified by the ICU pharmacist using an established collaborative practice agreement. As a pragmatic trial, at any point care teams may modify the empiric or subsequent dose based on their clinical judgement. | Other | Up-front individualized dosing algorithm |
| Usual CareThe standard of care group will receive empiric dosing guided by an institutional antimicrobial guide. Cefepime is typically dosed at 0.5-2 g every 8-24 h according to categorical thresholds of estimated creatinine clearance (eGFRcr). Cystatin C and eGFRcr-cys can be calculated and used at clinicians' discretion to aid in drug dose determination. | Other | Usual Care |
Primary outcome
Proportion of patients screened who qualified for the study
Time frame: 1 year or once the sample size is achieved
Number of patients who quality for the study out of total number of patients screened, reported as a percentage
Distribution of qualified patients across care teams
Time frame: 1 year or once the sample size is achieved
Number of patients from each ICU care team who qualify for the study
Adherence to dosing recommendations
Time frame: 1 year or once the sample size is achieved
Total number of patients randomized to the up-front individualized dosing algorithm who are prescribed the algorithm's recommended dosage
6 secondary outcomes
Number of antibiotic-free days
Time frame: 28-days
ICU length of stay
Time frame: 1 year
Proportion of patients who experience new anti-Pseudomonal beta-lactam resistance
Time frame: 6 months
Proportion of patients who experience clinical success
Time frame: 8 days
Proportion of patients who experience microbiologic success
Time frame: 8 days
Mortality
Time frame: 28-days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Background: PubMed 40013864Barreto EF, Scheetz MH, Chang J, Cole KC, Fogelson LA, Paul J, Jannetto PJ, Gajic O, Rule AD; Beta Lactam Optimization and Outcomes Management (BLOOM) Study Group. Cystatin C-Guided Dosing Nomogram Improves Target Attainment for Cefepime in the Critically Ill. Crit Care Med. 2025 Apr 1;53(4):e941-e952. doi: 10.1097/CCM.0000000000006622. Epub 2025 Feb 27.
- Individual participant dataSharing planned: No
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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.
Erin Barreto, PharmD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Up-front individualized dosing algorithm in people with Sepsis and Infection, run by Mayo Clinic at 1 site in United States.
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 3 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gerald W. Flaby Jr., LRT, RRT (507-422-3462, flaby.gerald@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients screened who qualified for the study (time frame: 1 year or once the sample size is achieved). The study lists 3 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 NCT07287332, which also lists 1 linked publication.
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 6 Feb 2026.