To study the vancomycin drug levels and its effect in patients in patients admitted to Pediatric Intensive Care Unit of Major hospital
Phase 4
Completed
- Conditions
- Health Condition 1: null- Patients admitted to PICU with suspected or proven bacterial infection
- Registration Number
- CTRI/2016/01/006527
- Lead Sponsor
- Seth GSMC and KEM Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
Inclusion Criteria
1.Voluntarily given written, signed, informed consent from legally acceptable representative and assent from patientâ??s aged >= 7 to 12 years before performing any screening procedures.
2.Either gender of aged 3 - 12 years and weight of >= 8 kg
3.Patients with suspected or proven Gram â?? positive bacterial infection
4.Patient receiving vancomycin therapy for at least 2 days
Exclusion Criteria
1.Patients with hypersensitivity to vancomycin hydrochloride or any excipients of its formulation or other drugs
2.Participation in any investigational study within 30 days prior to screening.
3.Patients whose Creatinine clearance <50ml/min
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method TPharmacokinetics-Pharmacodynamics relationship of vancomycin in children with suspected or proven Gram-positive bacterial infection admitted to Pediatric intensive care unit of tertiary care hospitalTimepoint: 1
- Secondary Outcome Measures
Name Time Method i. To assess the pharmacokinetics of intravenous vancomycin at steady state <br/ ><br> <br/ ><br>iii. To assess the association between AUC: MIC ratio of vancomycin with clinical outcome as assessed by survival or clinical cure. <br/ ><br>Timepoint: 1