Individualized vancomycin dosing for severe infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Central South University
  Changsha, Hunan, China Recruiting

Study contacts

• Principal investigator: Hainan Zhang, Doctor — Central South University
• Study coordinator: Hainan Zhang, Doctor
• Email: hainanzhang@csu.edu.cn
• Phone: 13508474343

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.