Comparison of vancomycin administration with and without loading dose

Comparison of the Area Under the Curve (AUC) of Vancomycin Administration With and Without Loading Dose in Patients Admitted to the Intensive Care Unit

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20120415009475N13

Enrollment

Registered

2022-11-17

Start date

2022-12-22

Completion date

Unknown

Last updated

2022-11-21

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

Conditions

Proven or suspected Infection with methicillin resistant staphylococcus aureus candidate for Vancomycin Treatment. Methicillin resistant Staphylococcus aureus infection, unspecified site

Interventions

Intervention 1: Intervention group: Vancomycin will be given at a loading dose of 30 mg/kg and continued at a dose of 15 mg/kg every 6 hours. Intervention 2: Control group: Vancomycin will be given at

Eligibility

Sex/Gender

All

Age

2 Months to 15 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactElahe Gholizade

Islamic Azad University

elahegholizadehm96@gmail.com+98 21 2222 7029

Outcome results

None listed

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