Individualized vancomycin dosing for severe infections

Clinical Study of Individualized Vancomycin Dosing Based on Population Pharmacokinetic Model for Severe Infections

This study tests if giving personalized doses of vancomycin can help people with severe infections do better than the standard dosing method.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 112 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Central South University (Academic / other)
• Locations: 1 site (Changsha, Hunan)
• Trial ID: NCT06161870 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the effectiveness of individualized vancomycin dosing based on a population pharmacokinetic model against standard empirical dosing in patients with severe infections. Participants will be randomly assigned to either the experimental group, which receives individualized dosing, or the control group, which receives empirical dosing. The study will collect data on demographic and clinical characteristics, as well as vancomycin concentration levels, to evaluate the clinical efficacy and safety of the individualized approach. The trial will involve 112 subjects treated for severe infections caused by gram-positive cocci during hospitalization.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older admitted to a neurological intensive care unit with severe gram-positive infections.

Not a fit: Patients with absolute renal impairment or those with non-neurological primary diagnoses may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective treatment of severe infections, improving patient outcomes and safety.

How similar studies have performed: Other studies have shown promise in using population pharmacokinetic models for drug dosing, suggesting potential success for this approach.

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.

Where this trial is running

Changsha, Hunan

• Central South University — Changsha, Hunan, China (Recruiting)

Study contacts

• Principal investigator: Hainan Zhang, Doctor — Central South University
• Study coordinator: Hainan Zhang, Doctor

Conditions Severe Infection; vancomycin; population pharmacokinetic model; severe infection