Vancomycin Dosage Strategy Based on a Trough Concentration Model
Clinical Evaluation of a Vancomycin Dosage Strategy Based on a Serum Trough Concentration Model in Elderly Patients With Severe Pneumonia
1 other identifier
interventional
66
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2019
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 7, 2019
CompletedFirst Posted
Study publicly available on registry
September 12, 2019
CompletedStudy Start
First participant enrolled
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedAugust 31, 2022
August 1, 2022
2.7 years
September 7, 2019
August 29, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Clinical success rate
Seven days after vancomycin withdrawal.
Vancomycin doses
At the end of vancomycin therapy, an average of 10 days.
Incidence of acute kidney injury
At the end of vancomycin treatment, an average of 10 days.
Study Arms (2)
Study group
EXPERIMENTALPatients of study group will accept vancomycin strategies decided by a serum trough concentration model.
Control group
NO INTERVENTIONPatients of control group will accept vancomycin dosages decided by attending physician.
Interventions
Dosage of Vancomycin decided by a serum trough concentration model, instead of decided by attending physician
Eligibility Criteria
You may qualify if:
- Patients with doubted or diagnosed Methicillin-resistant Staphylococcus aureus severe pneumonia, and need vancomycin treatment.
- Sixty years and older.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University Third Hospita
Beijing, Beijing Municipality, 100191, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Qingtao Zhou, Dr.
Peking University Third Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 7, 2019
First Posted
September 12, 2019
Study Start
October 1, 2019
Primary Completion
May 31, 2022
Study Completion
June 30, 2022
Last Updated
August 31, 2022
Record last verified: 2022-08