Pharmacokinetics Clinical Trial
Official title:
Prospective Individualization of the First Vancomycin Dose Using Population Pharmacokinetic Models.
| NCT number | NCT05964114 |
| Other study ID # | 7646 |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | October 2023 |
| Est. completion date | June 2026 |
| Verified date | July 2023 |
| Source | Erasmus Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
In 2020, only 16% of the Intensive Care Unit (ICU) patients achieved therapeutic drug concentrations after continuous administration of the first vancomycin dose. Many beneficial population pharmacokinetic (PPK) models are available however these are prevented from being widely implemented in daily practice due to the complexity. The aim of this study is to evaluate the effectiveness of individualized dosing with PPK models using a newly developed user-friendly pharmacokinetic (PK) tool. In a preceding retrospective study, the percentage of patients within the target range after initiation of continuous vancomycin increased from 28% to 39% (excluding CRRT and ECMO patients) with calculated concentrations based on theoretical dose adjustments. In this study we want to prospectively evaluate the concentration of vancomycin at 24, 28 and 72 hours after the start of treatment with individualized dosages based on (a combination) of available PPK models in 134 adult ICU and orthopedic patients.
| Status | Not yet recruiting |
| Enrollment | 134 |
| Est. completion date | June 2026 |
| Est. primary completion date | October 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Adult patients who receive continuous vancomycin treatment at the ICU or orthopaedic department - Patient or their legal representative is able and willing to sign the Informed Consent Form Exclusion Criteria: - Pregnant woman - Children - Patients with a transplantation history - Patients on continuous renal replacement therapy (CRRT) - Patients receiving extracorporeal membrane oxygenation (ECMO) |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Erasmus Medical Center |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of patients within target range of vancomycin for standard treatment versus treatment using MIPD within the first three days of treatment. | The percentage of patients with a vancomycin concentration within the therapeutic range (20-25 mg/L) in the first three days after start of treatment for standard of care (flat dose adjusted for renal function) versus MIPD dosing (starting dose determined using pharmacokinetic models). | two years |
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