Vancomycin Dosage Strategy Based on a Trough Concentration Model

Pneumonia, Staphylococcal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04088305
• Other study ID #: Y75505-03
• Status: Completed
• Phase: Phase 4
• Start date: October 1, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2022
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: June 30, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Staphylococcal

Intervention

Drug:
• Individualized therapy
Dosage of Vancomycin decided by a serum trough concentration model, instead of decided by attending physician

Locations

Country	Name	City	State
China	Peking University Third Hospita	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of vancomycin therapeutic serum trough concentrations	The proportion of patients with vancomycin serum trough concentrations reaching target concentrations (=15mg/L)will be compared between study group and control group	before the fifth vancomycin dosage
Secondary	Clinical success rate	the proportion of patients with clinical success	Seven days after vancomycin withdrawal.
Secondary	Vancomycin doses	Vancomycin daily doses and totally doses	At the end of vancomycin therapy, an average of 10 days.
Secondary	Incidence of acute kidney injury	The incidence of vancomycin-associated acute kidney injury	At the end of vancomycin treatment, an average of 10 days.