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OpenTrials
Completed

NCT Number: NCT04088305

Vancomycin Dosage Strategy Based on a Trough Concentration Model

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.

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Key information

Conditions

Pneumonia, Staphylococcal Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Lung Diseases Pneumonia Pneumonia, Bacterial Respiratory Tract Diseases Respiratory Tract Infections Staphylococcal Infections

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Peking University Third Hospita

Beijing, Beijing Municipality, 100191, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Individualized therapy

Drug

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

Other names: Vancomycin

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

Clinical Evaluation of a Vancomycin Dosage Strategy Based on a Serum Trough Concentration Model in Elderly Patients With Severe Pneumonia

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Sep 12, 2019
Registry last updated
Aug 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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