This is a study to optimise the dosing regimen for Vancomycin so that patient response to the drug can be improved.

Not yet recruiting

• Conditions: Unspecified staphylococcus as thecause of diseases classified elsewhere,

• Registration Number: CTRI/2023/02/049473
• Lead Sponsor: Prof Nusrat Shafiq

Brief Summary

A study to compare efficacy, safety, pharmacokinetic and pharmacodynamic parameters between conventional dosing regimen and optimised or alternate dosing regime in critically ill patients is planned to be carried out in our institute. We are comparing 1gram twice daily with 500 milligram four times daily. Vancomycin when administered at a dose of 1 gram twice daily may not reach adequate therapeutic concentration in serum as has been shown by a previous study done in our institute. So by this study we are planning to estimate the target concentration attainment of vancomycin in blood and to check if it leads to therapeutic efficacy, reduced mortality, reduction in treatment failure. The study is planned as a two arm parallel open label randomised control trial followed by single arm validation study. The allocation ratio is 1:1. The study will be conducted in Intensive care unit and Emergency wards in PGIMER, Chandigarh. The ethical clearance for this study has been obtained. Informed consent will be taken from the patients or legal attendants before enrolment in the study.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-01-02
• Study Start: 2023-07-02

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 36

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.	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
Proportion of patients alive at Day 28 in the treatment groups.	At the end of 28 days.
Proportion of patients requiring substitution of or addition to vancomycin with other antibiotics for the same indication.	5 days of therapy.
Number of days from vancomycin initiation to intensive care unit discharge.	5 days of therapy.
Duration of vasopressor support.	5 days of therapy.
Proportion of patients achieving trough concentration of 15-20 in both the treatment groups.	Second day after starting therapy.
Proportion of patients alive at the end of treatment in both the treatment groups.	5 days of therapy.
Proportion of clinical failure at the end of treatment in both the treatment groups.	5 days of therapy.
To compare the frequency of patient readmission between the treatment groups.	At the end of 28 days.

Trial Locations

Locations (1)

Post Graduate Institute of Medical Education and Research; 🇮🇳 Chandigarh, CHANDIGARH, India

Post Graduate Institute of Medical Education and Research

🇮🇳Chandigarh, CHANDIGARH, India

Prof Nusrat Shafiq

Principal investigator

9478000822

nusrat.shafiq.pgi@gmail.com