NCT06161870 Clinical Study of Individualized Vancomycin Dosing Based on Population PK Model
| NCT ID | NCT06161870 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Central South University |
| Condition | Severe Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 112 participants |
| Start Date | 2021-01-01 |
| Primary Completion | 2024-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 112 participants in total. It began in 2021-01-01 with a primary completion date of 2024-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to compare the clinical efficacy of individualized dosing based on the population pharmacokinetics (PK) model and empirical dosing of vancomycin in participants with severe infections. It aims to answer whether individual vancomycin dosing based on population PK model is superior to empirical dosing in terms of clinical efficacy and safety. Participants will be randomly divided into experimental group and control group. The experimental group will be guided by the population PK model for individual dosing, and the control group will be given empirical dosing. Demographic data, clinical characteristics of participants, and their trough concentrations (Cmin) and peak concentrations (Cmax) of vancomycin will be collected. Area under the concentration curve (AUC24) of participants will be calculated using the first-order PK equation. Researchers will compare experimental group and control group to see if individual vancomycin dosing based on population PK model is superior to empirical dosing in terms of clinical efficacy and safety.
Eligibility Criteria
Inclusion Criteria: 1. Admission to neurological intensive care unit (NICU). 2. Age ≥18 years old. Participants will be eligible if they meet both of these criteria. Exclusion Criteria: 1. Evidence of absolute renal impairment, which included Serum creatinine (SCR) ≥133 μmol/L at admission, development of acute kidney injury (AKI) after admission, need for renal replacement therapy during hospitalization, renal related tests suggestive of renal disease, and previous history of renal replacement therapy or chronic kidney disease. 2. Pregnant participants. 3. Primary diagnosis is non-neurological disease. 4. The height or weight of participants is not recorded in the medical record system. 5. The frequency of SCR monitoring was less than 3 times. Participants who meet any of these criteria will be excluded.
Contact & Investigator
Hainan Zhang, Doctor
PRINCIPAL INVESTIGATOR
Central South University
Frequently Asked Questions
Who can join the NCT06161870 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Severe Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06161870 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06161870 currently recruiting?
Yes, NCT06161870 is actively recruiting participants. Contact the research team at hainanzhang@csu.edu.cn for enrollment information.
Where is the NCT06161870 trial being conducted?
This trial is being conducted at Changsha, China.
Who is sponsoring the NCT06161870 clinical trial?
NCT06161870 is sponsored by Central South University. The principal investigator is Hainan Zhang, Doctor at Central South University. The trial plans to enroll 112 participants.