Health Condition 1: null- Patients admitted to PICU with suspected or proven bacterial infection
Conditions
Interventions
Intervention1: Vancomycin: Vancomycin is a glycopeptide antibiotic used treat the suspected or proven gram positive bacterial infection. 20mg/kg/dose every 8 hours. 1 vial (500mg) will be diluted in 5
Sponsors
Seth GSMC and KEM Hospital
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| i. To assess the pharmacokinetics of intravenous vancomycin at steady state iii. To assess the association between AUC: MIC ratio of vancomycin with clinical outcome as assessed by survival or clinical cure. Timepoint: 1 | — |
Countries
India
Contacts
Public ContactNitin Mali
Seth GSMC and KEM Hospital
Outcome results
None listed