Cefepime Dosing for Infections

Overseen By Gerald W. Flaby Jr., LRT, RRT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must be taking: Cefepime

Disqualifiers: Cephalosporin allergy, Acute kidney injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 days

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods of administering cefepime, an antibiotic, to critically ill patients. One group receives the usual dosing, while the other receives doses tailored to kidney function and weight. The main goal is to assess the ease of use for doctors and whether it helps patients recover faster with fewer side effects. This trial suits adults in the ICU who are prescribed cefepime and have no allergy to it. As an unphased trial, it provides a unique opportunity to contribute to research that could enhance antibiotic treatment for ICU patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this new dosing method is safe for patients?

Research shows that cefepime, the antibiotic under study, is generally safe for people. One study tested a new dosing method based on kidney function and weight, finding it safe and effective. In this study, patients with pneumonia who received cefepime doses adjusted by cystatin C (a protein that checks kidney function) had safety results similar to the usual dosing method.

Another study found that using cystatin C to guide dosing occurs mostly in intensive care units and has been used without major safety problems. Cefepime is also FDA-approved for other infections, indicating its safety in many cases. Overall, research shows that cefepime is well-tolerated, with no unexpected safety issues reported in these studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way of dosing cefepime for infections. Unlike the usual care, which relies on a broad, empiric dosing method based on a few kidney function categories, this trial uses an individualized dosing algorithm. This algorithm takes into account more detailed factors like eGFRcr-cysC and a patient's weight, aiming for more precise and potentially more effective treatment. By tailoring the dose more closely to each patient's needs, the trial hopes to improve outcomes and reduce side effects, making treatment with cefepime safer and more efficient.

What evidence suggests that this new dosing method for cefepime is effective for infections?

Research has shown that using a personalized method to determine cefepime doses, which considers both cystatin C and creatinine levels, can enhance the drug's effectiveness for very sick patients. In this trial, participants in the "Up-front individualized dosing algorithm" arm will receive cefepime doses adjusted based on this personalized approach, which accounts for kidney function to provide more precise treatment. Studies have found that this method helps achieve the right drug levels in the body, leading to faster recovery and fewer side effects. For instance, patients with pneumonia have experienced better outcomes with this tailored dosing compared to the standard method. This personalized approach shows promise, especially for critically ill patients. Meanwhile, participants in the "Usual Care" arm will receive cefepime based on standard empiric dosing guidelines. ^{1 2 3 6 7}

Who Is on the Research Team?

Erin Barreto, PharmD, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for very sick patients with severe bacterial skin infections or sepsis, which is a dangerous body response to infection. Participants must have certain conditions like acute bacterial skin and skin structure infections or septic shock. The study excludes specific details not provided.

Inclusion Criteria

Admitted to one of the ICUs at the study center

I am prescribed cefepime by my doctor.

I am 18 years old or older.

Exclusion Criteria

Declined Minnesota research authorization

Individuals with a cephalosporin allergy

I was given cefepime before being admitted to the ICU.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the usual dosing or the new individualized dosing method of cefepime

8 days

Daily monitoring during ICU stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of antibiotic resistance and clinical success

6 months

Periodic assessments

What Are the Treatments Tested in This Trial?

Interventions

• Cefepime

Trial Overview

The BLOOM trial compares usual antibiotic dosing with a new individualized method based on patient information such as kidney function. It aims to see if healthcare professionals can easily use the new method and how it affects patient recovery and side effects.

How Is the Trial Designed?

Group I: Up-front individualized dosing algorithm Experimental Treatment 1 Intervention

Clinical decision support to encourage use of an individualized cefepime dosing algorithm based on eGFRcr-cysC and weight.

Group II: Usual Care Active Control 1 Intervention

The standard of care group will receive empiric dosing of cefepime, using an institutional antimicrobial guide based on four categories of eGFRcr.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12620034/

Cystatin C-Guided Dosing Nomogram Improves Target ...

The purpose of this study was to create and evaluate a cefepime dosing nomogram based on both creatinine and cystatin C to estimated glomerular ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07287332

NCT07287332 | BLOOM: Pragmatic Feasibility Trial

An individualized cefepime dosing algorithm will be used to determine the cefepime dose and interval.

3.

mdpi.com

mdpi.com/2077-0383/9/9/2803

Efficacy and Safety of Cystatin C-Guided Renal Dose ...

We investigated the efficacy and safety of CysC-guided cefepime dosing compared with SCr-guided dosing in hospitalized patients with pneumonia.

4.

researchgate.net

researchgate.net/publication/389400281_Cystatin_C-Guided_Dosing_Nomogram_Improves_Target_Attainment_for_Cefepime_in_the_Critically_Ill

Cystatin C-Guided Dosing Nomogram Improves Target ...

This study created and evaluated a cefepime dosing nomogram based on eGFR cr-cys for initial dosing in the critically ill. Design ...

5.

astctjournal.org

astctjournal.org/article/S2666-6367(24)00296-3/fulltext

Cystatin C Outperforms Creatinine in Predicting Cefepime ...

Cefepime is used for empiric coverage post-HSCT and requires dose adjustment based on kidney function.

6.

researchgate.net

researchgate.net/publication/343991868_Efficacy_and_Safety_of_Cystatin_C-Guided_Renal_Dose_Adjustment_of_Cefepime_Treatment_in_Hospitalized_Patients_with_Pneumonia

(PDF) Efficacy and Safety of Cystatin C-Guided Renal ...

We investigated the efficacy and safety of CysC-guided cefepime dosing compared with SCr-guided dosing in hospitalized patients with pneumonia.

7.

accpjournals.onlinelibrary.wiley.com

accpjournals.onlinelibrary.wiley.com/doi/full/10.1002/jac5.70035

Implementing use of cystatin C‐guided estimated glomerular ...

An audit revealed that cystatin C was primarily used in intensive care units for dosing antibiotics like cefepime and vancomycin. In response, ...