Comparison of vancomycin administration with and without loading dose

Phase 3

• Conditions: Proven or suspected Infection with methicillin resistant staphylococcus aureus candidate for Vancomycin Treatment.; Methicillin resistant Staphylococcus aureus infection, unspecified site; A49.02

• Registration Number: IRCT20120415009475N13
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Age 2 months to 15 years old
Weight under 33 kg
Obtaining written consent from a legal guardian

Exclusion Criteria

Renal impairment, GFR<50 ml/min (Schwartz formula)
Need for hemodialysis or CRRTNeed for extracorporeal membrane oxygenation or plasmapheresis
Discontinuation of vancomycin before 3 days of administration due to clinical judgment
Retraction of consent by the legal guardian
Lysis of blood samples

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum level of vancomycin. Timepoint: Third day of receiving vancomycin. Method of measurement: Fluorescence Polarization Immunoassays.;Clinical response. Timepoint: 5 Days after intervention. Method of measurement: Use the Pediatric Sequential Organ Failure Assessment score and Pediatric Risk of Mortality III score to predict mortality in the pediatric intensive care unit.;Infusion-related reactions. Timepoint: 5 Days after intervention. Method of measurement: Sign and symptoms of the red man syndrome.;Nephrotoxicity. Timepoint: 8 days after intervention. Method of measurement: Serum creatinine measurement and daily urine output.