Vancomycin Dosage Strategy Based on a Trough Concentration Model

Phase 4

Completed

• Conditions: Pneumonia, Staphylococcal
• Interventions: Drug: Individualized therapy

• Registration Number: NCT04088305
• Lead Sponsor: Peking University Third Hospital

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.

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 Timeline

• Study First Submitted: 2019-09-07
• Study First Submitted QC: 2019-09-11
• Study First Posted: 2019-09-12
• Study Start: 2019-10-01
• Primary Completion: 2022-05-31
• Study Completion: 2022-06-30
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-29
• Last Update Posted: 2022-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	Individualized therapy	Patients of study group will accept vancomycin strategies decided by a serum trough concentration model.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Peking University Third Hospita; 🇨🇳 Beijing, Beijing, China