Vancomycin Dosage Strategy Based on a Trough Concentration Model

Sponsor

Peking University Third Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04088305

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pneumonia, Staphylococcal	Drug: Individualized therapy	Phase 4

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Clinical Evaluation of a Vancomycin Dosage Strategy Based on a Serum Trough Concentration Model in Elderly Patients With Severe Pneumonia

Actual Study Start Date :

Oct 1, 2019

Anticipated Primary Completion Date :

May 31, 2022

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study group Patients of study group will accept vancomycin strategies decided by a serum trough concentration model.	Drug: Individualized therapy Dosage of Vancomycin decided by a serum trough concentration model, instead of decided by attending physician Other Names: Vancomycin
No Intervention: Control group Patients of control group will accept vancomycin dosages decided by attending physician.

Arm

Intervention/Treatment

Experimental: Study group

Patients of study group will accept vancomycin strategies decided by a serum trough concentration model.

Drug: Individualized therapy

Dosage of Vancomycin decided by a serum trough concentration model, instead of decided by attending physician

Other Names:

Vancomycin

No Intervention: Control group

Patients of control group will accept vancomycin dosages decided by attending physician.

Outcome Measures

Primary Outcome Measures

The incidence of vancomycin therapeutic serum trough concentrations [before the fifth vancomycin dosage]
The proportion of patients with vancomycin serum trough concentrations reaching target concentrations (≥15mg/L)will be compared between study group and control group

Secondary Outcome Measures

Clinical success rate [Seven days after vancomycin withdrawal.]
the proportion of patients with clinical success
Vancomycin doses [At the end of vancomycin therapy, an average of 10 days.]
Vancomycin daily doses and totally doses
Incidence of acute kidney injury [At the end of vancomycin treatment, an average of 10 days.]
The incidence of vancomycin-associated acute kidney injury

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts 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.