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NCT05224687
Utility Assessment of a Pharmacy-to-Dose Daptomycin
trial testing Retroactive review of patient data of those receiving a dose of daptomycin in Antibiotics Causing Adverse Effects in Therapeutic Use in 100 participants. Status unknown.
15 December 2022
Quick facts
| Lead sponsor | Methodist Health System |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 100 |
| Start date | 15 December 2021 |
| Primary completion | 15 December 2022 |
| Estimated completion | 15 December 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Retroactive review of patient data of those receiving a dose of daptomycin
Conditions studied
- Antibiotics Causing Adverse Effects in Therapeutic Use — all drugs for Antibiotics Causing Adverse Effects in Therapeutic Use →
Sponsor
Methodist Health System — full company profile →
Who can join
Eligibility, any sex, with Antibiotics Causing Adverse Effects in Therapeutic Use. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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. 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05224687
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05224687 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Methodist Health System
- Last refreshed: 4 February 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05224687.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing