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Antibiotics Causing Adverse Effects in Therapeutic UseNCT05224687

Utility Assessment of a Pharmacy-to-Dose Daptomycin

An observational study of Antibiotics Causing Adverse Effects in Therapeutic Use, run by Methodist Health System at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A pharmacy-to-dose (PTD) service, also referred to as pharmacy-based dosing, describes an established practice where providers can consult pharmacists for the dosing of various medications. Read more about this study

Who is it for?
Any age
What is being tested?
Retroactive review of patient data of those receiving a dose of daptomycin
How many people
100 participants
Where
1 siteUnited States
Study dates
15 Dec 2021to 15 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 Any age
  • Child, Adult, Older adult

Study population: Patients receiving a dose of daptomycin at MCMC, Methodist Dallas Medical Center, Methodist Richardson Medical Center, or Methodist Mansfield Medical Center.

Who may be able to join

  • ≥ 18 years old
  • Have weight and renal function documented prior to daptomycin order entry
  • Received at least one dose of daptomycin at any MHS facility

Who cannot join

  • Patients will be excluded if daptomycin was started at an outside facility and their dose was continued during their inpatient stay.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Methodist Dallas Medical Center

    Dallas, Texas, 75203

Other trials in United States

About this study

Official title: Utility Assessment of a Pharmacy-to-Dose Daptomycin Protocol: A Retrospective Cohort Study

A pharmacy-to-dose (PTD) service, also referred to as pharmacy-based dosing, describes an established practice where providers can consult pharmacists for the dosing of various medications. Consulted pharmacists develop a treatment regimen utilizing protocols that are evaluated and approved by the relevant multidisciplinary committees of an institution.

Delegating tasks of therapy monitoring and dose selection to pharmacists resolves providers from this burden and ensures necessary changes are not unnoticed. Daptomycin was a medication that our facility included in PTD because of the required adjustments for renal dysfunction, indication dependent dosing, and its impact on clinical outcomes.

In 2019, our institution approved a PTD daptomycin protocol which allowed pharmacists to select a dose based on provider-selected indications, patient renal function, and body mass index. Pharmacists were also authorized to order creatine phosphokinase (CPK) levels at baseline and every 7 days, if the patient remained on daptomycin. Rounding the dose to the nearest 50 mg or vial size, as deemed appropriate, was also allowed. Daptomycin was one antimicrobial to be added to our growing list of PTD-approved medications. As such, pharmacists were already well acclimated to PTD processes by the time daptomycin was approved for this service.

Read the detailed description

A pharmacy-to-dose (PTD) service, also referred to as pharmacy-based dosing, describes an established practice where providers can consult pharmacists for the dosing of various medications. Consulted pharmacists develop a treatment regimen utilizing protocols that are evaluated and approved by the relevant multidisciplinary committees of an institution. The Institute for Healthcare Improvement (IHI) recommends implementing pharmacy-based dosing to improve core processes for ordering medications.

Consults for PTD services that require a provider to enter the desired medication and indication have been evaluated in prior studies. This type of consultation requires a clinical or staff pharmacist to implement a patient-specific dosing regimen in addition to ordering of pertinent labs for therapeutic monitoring. Literature on PTD is most prominent regarding pharmacist led services for the dosing and monitoring of vancomycin and aminoglycosides. This is expected because appropriate use of both vancomycin and aminoglycosides relies on ordering and assessment of pharmacokinetic (PK) measurements. As new recommendations for vancomycin dosing and monitoring evolve in complexity, these services are becoming even more valuable. Hospitals with pharmacist-managed vancomycin and aminoglycoside therapy have shown lower drug costs, hearing and renal impairment, and death rates in Medicare patients compared to hospitals without these services.

Other medications that either require renal adjustments, have a narrow therapeutic index, include a wide range of dosing for various indications, or require careful consideration of patient-specific factors are excellent candidates for expanded PTD services. Pharmacists serve as institutions' medication experts and are equipped with knowledge and references needed to apply patient specific characteristics to the selection of a dosing regimen. Medications that require monitoring for the prevention of adverse effects or changes in dosing, often due to the dynamic nature of hospitalized patients' renal function, sometimes go unaddressed. Delegating tasks of therapy monitoring and dose selection to pharmacists resolves providers from this burden and ensures necessary changes are not unnoticed. Daptomycin was a medication that our facility included in PTD because of the required adjustments for renal dysfunction, indication dependent dosing, and its impact on clinical outcomes.

Daptomycin is a cyclic lipopeptide antibiotic that exhibits rapid bactericidal activity against Gram-positive organisms, including various drug resistant isolates of Enterococcus and Staphylococcus. The mechanism does not involve entrance into the bacterial cytoplasm but rather the dissipation of the membrane potential, which occurs through permeable oligomeric lesions in a calcium-dependent fashion. Peak concentration (Cmax)/minimum inhibitory concentration (MIC) and area under the curve (AUC24h)/MIC ratios have been shown in vivo to correlate best with efficacy. Doses of 4 and 6 mg/kg/dose are Food and Drug Administration (FDA)-approved to treat complicated skin and skin structure infections and S. aureus bloodstream infections including right-sided infective endocarditis, respectively. The MICs of daptomycin for Gram-positive cocci differ. Enterococcus faecalis is marked susceptible with MICs ≤ 2 µg/mL; however, strains of Enterococcus faecium display intrinsically higher MICs, and dose-dependent susceptibility based on treatment doses of 8-12 mg/kg/day.

In 2019, our institution approved a PTD daptomycin protocol which allowed pharmacists to select a dose based on provider-selected indications, patient renal function, and body mass index. Pharmacists were also authorized to order creatine phosphokinase (CPK) levels at baseline and every 7 days, if the patient remained on daptomycin. Rounding the dose to the nearest 50 mg or vial size, as deemed appropriate, was also allowed. Daptomycin was one antimicrobial to be added to our growing list of PTD-approved medications. As such, pharmacists were already well acclimated to PTD processes by the time daptomycin was approved for this service.

Being tested
Retroactive review of patient data of those receiving a dose of daptomycin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Retroactive review of patient data of those receiving a dose of daptomycinOther

    A retrospective analysis will be conducted using patient data of those receiving a dose of daptomycin at MCMC, Methodist Dallas Medical Center, Methodist Richardson Medical Center, or Methodist Mansfield Medical Center.

Study groups in NCT05224687
Study groupRoleWhat they receive
Daptomycin are dosed solely by pharmacistsDaptomycin at two institutions are dosed solely by pharmacists
Receives: Other: Retroactive review of patient data of those receiving a dose of daptomycin
daptomycin protocol is not used and dose by the providerdaptomycin PTD is optional or not utilized at the other institutions.
Receives: Other: Retroactive review of patient data of those receiving a dose of daptomycin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the proportion of patients receiving appropriate dosing of daptomycin based on indication, weight

    Weight in pounds

    Measured: July 2019 to October 2021

  2. The primary endpoint is the proportion of patients receiving appropriate dosing of daptomycin based on indication renal function

    creatinine clearance

    Measured: July 2019 to October 2021

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2022
  2. Study start15 Dec 2021
  3. Primary completion15 Dec 2022 (estimated)
  4. Study completion15 Dec 2022 (estimated)

Resources

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
Cohort
Time perspective
Retrospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05224687
Sponsor's protocol ID
068.PHA.2021.A
Status last verified
Feb 2022
First submitted
3 Feb 2022
Last updated
4 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Antibiotics Causing Adverse Effects in Therapeutic Use, run by Methodist Health System 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 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: status not confirmed, as of the sponsor's last update on 4 Feb 2022. 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?

Results are not available in the source record.

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?

the proportion of patients receiving appropriate dosing of daptomycin based on indication, weight (time frame: July 2019 to October 2021). 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?
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 4 Feb 2022.

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