Vancomycin Dosage Strategy Based on a Trough Concentration Model

NCT ID: NCT04088305

Last Updated: 2022-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2022-06-30

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.

Conditions

Pneumonia, Staphylococcal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study group

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

Group Type: EXPERIMENTAL

Individualized therapy

Intervention Type: DRUG

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

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Individualized therapy

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

Intervention Type: DRUG

Other Intervention Names

Vancomycin

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Qingtao Zhou

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Qingtao Zhou, Dr.

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Locations

Peking University Third Hospita

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

Y75505-03

Identifier Type: -

Identifier Source: org_study_id