- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04088305
Vancomycin Dosage Strategy Based on a Trough Concentration Model
August 29, 2022 updated by: Qingtao Zhou, Peking University Third Hospital
Clinical Evaluation of a Vancomycin Dosage Strategy Based on a Serum Trough Concentration Model in Elderly Patients With Severe Pneumonia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
66
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100191
- Peking University Third Hospita
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Study group
Patients of study group will accept vancomycin strategies decided by a serum trough concentration model.
|
Dosage of Vancomycin decided by a serum trough concentration model, instead of decided by attending physician
Other Names:
|
No Intervention: Control group
Patients of control group will accept vancomycin dosages decided by attending physician.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incidence of vancomycin therapeutic serum trough concentrations
Time Frame: 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
|
before the fifth vancomycin dosage
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical success rate
Time Frame: Seven days after vancomycin withdrawal.
|
the proportion of patients with clinical success
|
Seven days after vancomycin withdrawal.
|
Vancomycin doses
Time Frame: At the end of vancomycin therapy, an average of 10 days.
|
Vancomycin daily doses and totally doses
|
At the end of vancomycin therapy, an average of 10 days.
|
Incidence of acute kidney injury
Time Frame: At the end of vancomycin treatment, an average of 10 days.
|
The incidence of vancomycin-associated acute kidney injury
|
At the end of vancomycin treatment, an average of 10 days.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Qingtao Zhou, Dr., Peking University Third Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2019
Primary Completion (Actual)
May 31, 2022
Study Completion (Actual)
June 30, 2022
Study Registration Dates
First Submitted
September 7, 2019
First Submitted That Met QC Criteria
September 11, 2019
First Posted (Actual)
September 12, 2019
Study Record Updates
Last Update Posted (Actual)
August 31, 2022
Last Update Submitted That Met QC Criteria
August 29, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Staphylococcal Infections
- Pneumonia, Bacterial
- Pneumonia
- Pneumonia, Staphylococcal
- Anti-Infective Agents
- Anti-Bacterial Agents
- Vancomycin
Other Study ID Numbers
- Y75505-03
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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