Vancomycin Dosage Strategy Based on a Trough Concentration Model

Peking University

Status and phase

Completed

Phase 4

Conditions

Pneumonia, Staphylococcal

Treatments

Drug: Individualized therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04088305

Y75505-03

Details and patient eligibility

About

Study design:

Allocation: Randomized Endpoint classification: Efficacy study Masking: Open label Primary purpose: Treatment Primary endpoint: Incidence of reaching the target serum trough concentration Secondary endpoint: Clinical efficiency, Antibiotic use, acute kidney injury.

Full description

This is a prospective randomized control trial. There are two groups, study group and control group. Patients of study group accepted vancomycin strategies decided by a serum trough concentration model, and patients of control group accepted vancomycin dosage decided by attending physician. The primary endpoint is the incidence of reaching the target serum trough concentration, the secondary endpoint are clinical efficiency, antibiotic use and side effects such as acute kidney injury, etc.

Enrollment

66 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with doubted or diagnosed Methicillin-resistant Staphylococcus aureus severe pneumonia, and need vancomycin treatment.
Sixty years and older.

Exclusion criteria

younger than 60 years old
Accepted blood purification therapy
Pregnancy
Positive HIV antibody titre
Had known or suspected tuberculosis or other infections caused by fungi at baseline.