Back to resultsVancomycin Dosage Strategy Based on a Trough Concentration Model
Primary Purpose
Pneumonia, Staphylococcal
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Individualized therapy
Sponsored by
About this trial
This is an interventional treatment trial for Pneumonia, Staphylococcal focused on measuring pneumonia, vancomycin, trough concentration, elderly patients
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.
Sites / Locations
- Peking University Third Hospita
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Study group
Control group
Arm Description
Patients of study group will accept vancomycin strategies decided by a serum trough concentration model.
Patients of control group will accept vancomycin dosages decided by attending physician.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Clinical success rate
the proportion of patients with clinical success
Vancomycin doses
Vancomycin daily doses and totally doses
Incidence of acute kidney injury
The incidence of vancomycin-associated acute kidney injury
Full Information
NCT ID
NCT04088305
First Posted
September 7, 2019
Last Updated
August 29, 2022
Sponsor
Peking University Third Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04088305
Brief Title
Vancomycin Dosage Strategy Based on a Trough Concentration Model
Official Title
Clinical Evaluation of a Vancomycin Dosage Strategy Based on a Serum Trough Concentration Model in Elderly Patients With Severe Pneumonia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Third Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Staphylococcal
Keywords
pneumonia, vancomycin, trough concentration, elderly patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
Patients of study group will accept vancomycin strategies decided by a serum trough concentration model.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients of control group will accept vancomycin dosages decided by attending physician.
Intervention Type
Drug
Intervention Name(s)
Individualized therapy
Other Intervention Name(s)
Vancomycin
Intervention Description
Dosage of Vancomycin decided by a serum trough concentration model, instead of decided by attending physician
Primary Outcome Measure Information:
Title
The incidence of vancomycin therapeutic serum trough concentrations
Description
The proportion of patients with vancomycin serum trough concentrations reaching target concentrations (≥15mg/L)will be compared between study group and control group
Time Frame
before the fifth vancomycin dosage
Secondary Outcome Measure Information:
Title
Clinical success rate
Description
the proportion of patients with clinical success
Time Frame
Seven days after vancomycin withdrawal.
Title
Vancomycin doses
Description
Vancomycin daily doses and totally doses
Time Frame
At the end of vancomycin therapy, an average of 10 days.
Title
Incidence of acute kidney injury
Description
The incidence of vancomycin-associated acute kidney injury
Time Frame
At the end of vancomycin treatment, an average of 10 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qingtao Zhou, Dr.
Organizational Affiliation
Peking University Third Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Third Hospita
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
12. IPD Sharing Statement
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Vancomycin Dosage Strategy Based on a Trough Concentration Model
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