Utility Assessment of a Pharmacy-to-Dose Daptomycin

NCT05224687 | Unknown

• 1 other identifier: 068.PHA.2021.A
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Antibiotics Causing Adverse Effects in Therapeutic Use

Outcome Measures

Primary Outcomes (2)

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

  Weight in pounds

  July 2019 to October 2021

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

  creatinine clearance

  July 2019 to October 2021

Study Arms (2)

Daptomycin are dosed solely by pharmacists

Daptomycin at two institutions are dosed solely by pharmacists

Other: Retroactive review of patient data of those receiving a dose of daptomycin

daptomycin protocol is not used and dose by the provider

daptomycin PTD is optional or not utilized at the other institutions.

Other: Retroactive review of patient data of those receiving a dose of daptomycin

Interventions

Retroactive review of patient data of those receiving a dose of daptomycin OTHER

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.

Daptomycin are dosed solely by pharmacists; daptomycin protocol is not used and dose by the provider

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• ≥ 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

You may not qualify if:

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

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

Study Officials

• Ronda Akins, PharmD

  Methodist Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: February 4, 2022
• Study Start: December 15, 2021
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: February 4, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)