This is a study to optimise the dosing regimen for Vancomycin so that patient response to the drug can be improved.
Not Applicable
- Conditions
- Health Condition 1: B958- Unspecified staphylococcus as thecause of diseases classified elsewhere
- Registration Number
- CTRI/2023/02/049473
- Lead Sponsor
- Prof Nusrat Shafiq
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Critically ill adults admitted to intensive care unit or emergency ward where intravenous vancomycin therapy is deemed necessary based on suspected or confirmed infectious aetiology.
Exclusion Criteria
Patients less than 18 years.
Patients requiring renal replacement therapy.
Patients with end stage renal disease.
Patients with end stage hepatic failure.
Any contraindication or history of hypersensitivity with use of vancomycin.
Pregnant and lactating women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients achieving AUC 0-24 hours/MIC ratio more than 400 in both the treatment groups.Timepoint: Time points considered will be 15 minutes, 30 minutes, 2 hours, 6 hours, 23.5 hours after administration of dose.
- Secondary Outcome Measures
Name Time Method Duration of vasopressor support.Timepoint: 5 days of therapy.;Number of days from vancomycin initiation to intensive care unit discharge.Timepoint: 5 days of therapy.;Proportion of clinical failure at the end of treatment in both the treatment groups.Timepoint: 5 days of therapy.;Proportion of patients achieving trough concentration of 15-20 in both the treatment groups.Timepoint: Second day after starting therapy.;Proportion of patients alive at Day 28 in the treatment groups.Timepoint: At the end of 28 days.;Proportion of patients alive at the end of treatment in both the treatment groups.Timepoint: 5 days of therapy.;Proportion of patients requiring substitution of or addition to vancomycin with other antibiotics for the same indication.Timepoint: 5 days of therapy.;To compare the frequency of patient readmission between the treatment groups.Timepoint: At the end of 28 days.