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Vancomycin Dosage Strategy Based on a Trough Concentration Model

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04088305
Recruitment Status : Not yet recruiting
First Posted : September 12, 2019
Last Update Posted : September 12, 2019
Information provided by (Responsible Party):
Qingtao Zhou, Peking University Third Hospital

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.

Condition or disease Intervention/treatment Phase
Pneumonia, Staphylococcal Drug: Dose Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of a Vancomycin Dosage Strategy Based on a Serum Trough Concentration Model in Elderly Patients With Severe Pneumonia
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: Study group
Patients of study group will accept vancomycin strategies decided by a serum trough concentration model.
Drug: Dose
Dosage of Vancocin decided by a serum trough concentration, instead of decided by attending physician

No Intervention: Control group
Patients of control group will accept vancomycin dosages decided by attending physician.

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Clinical success rate [ Time Frame: Seven days after vancomycin withdrawal. ]
    the proportion of patients with clinical success

  2. Vancomycin doses [ Time Frame: At the end of vancomycin therapy, an average of 10 days. ]
    Vancomycin daily doses and totally doses

  3. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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Responsible Party: Qingtao Zhou, Professor, Peking University Third Hospital Identifier: NCT04088305    
Other Study ID Numbers: Y75505-03
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Qingtao Zhou, Peking University Third Hospital:
trough concentration
elderly patients
Additional relevant MeSH terms:
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Pneumonia, Staphylococcal
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Pneumonia, Bacterial
Anti-Bacterial Agents
Anti-Infective Agents