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

Comparison of efficacy, safety, pharmacokinetic and pharmacodynamic parameters between conventional dosing regimen of vancomycin with novel optimized dosing regimen in critically ill patients.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/02/049473
Enrollment
36
Registered
2023-02-06
Start date
Unknown
Completion date
Unknown
Last updated
2023-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B958- Unspecified staphylococcus as thecause of diseases classified elsewhere

Interventions

Intervention1: Vancomycin 500 mg: The patients on intervention arm will be given 500 mg of Vancomycin 4 times daily intravenously at an interval of 6 hours for a period of 5 days. Control Intervention

Sponsors

Prof Nusrat Shafiq
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.—

Countries

India

Contacts

Public ContactProf Samir Malhotra

Postgraduate institute of medical education and research (PGIMER), Chandigarh

nusrat.shafiq.pgi@gmail.com9478000822

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026