Comparison of Vancomycin Area Under the Curve (AUC) in Continuous and Intermittent Infusion Regimens in Pediatric Patients Admitted to the Intensive Care Unit
Comparison of Vancomycin Area Under the Curve (AUC) in Continuous and Intermittent Infusion Regimens in Pediatric Patients Admitted to the Intensive Care Unit
Design
A randomized, blinded, and controlled phase three clinical trial with a parallel-group design of 72 patients; Randomisation was centralised and computerised with block randomisation sequence carried out at an sealed envelope.com site.
Settings and conduct
Place of study: A Tertiary Teaching Children's Hospital
How to do the study: Seventy-two patients who are candidates for vancomycin therapy are randomly divided into intervention or control groups. Investigator, outcome assessor and data analyzer are blind to the study groups until the end of the study
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 2 months to 15 years old, weight under 67 kg, central venous access, obtaining written consent from a legal guardian
Exclusion criteria: Renal impairment, GFR<50 ml/min (Schwartz formula), required extracorporeal membrane oxygenation or plasmapheresis, discontinuation of vancomycin before 3 days after administration due to clinical judgment
Intervention groups
Intervention group: Vancomycin will be received as a loading dose of 15mg/kg and a continuous infusion of 60mg/kg over 24 hours. The Control group will receive vancomycin as an intermittent infusion of 15mg/kg every 6 hours.
Main outcome variables
Vancomycin area under the curve (AUC)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120415009475N12
Registration date:2022-07-05, 1401/04/14
Registration timing:prospective
Last update:2022-07-05, 1401/04/14
Update count:0
Registration date
2022-07-05, 1401/04/14
Registrant information
Name
Bahador Mirrahimi
Name of organization / entity
Shahid Beheshti University of Medical Sciences, Faculty of Pharmacy
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 0118
Email address
mirrahimi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-23, 1401/06/01
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Vancomycin Area Under the Curve (AUC) in Continuous and Intermittent Infusion Regimens in Pediatric Patients Admitted to the Intensive Care Unit
Public title
Comparison of continuous and intermittent infusion administration methods of Vancomycin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 2 months to 15 years old
Weight under 67 kg
Central venous access
Obtaining written consent from a legal guardian
Exclusion criteria:
Renal impairment, GFR<50 ml/min (Schwartz formula)
Need for hemodialysis or CRRT
Need for extracorporeal membrane oxygenation or plasmapheresis
Loss of Central venous access
Lysis of blood samples
Discontinuation of vancomycin before 3 days of administration due to clinical judgment
Retraction of consent by legal guardian
Age
From 2 months old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
72
More than 1 sample in each individual
Number of samples in each individual:
2
Two separate blood samples will be taken from the patient at different times within 24 hours
Randomization (investigator's opinion)
Randomized
Randomization description
The Block randomization method will be used in this study. Eighteen blocks including four patients will be generated with the online website (www.sealedenvelope.com/simple-randomiser/v1). In each block, two patients will be randomly assigned to the continuous infusion group and two patients will be assigned to the intermittent infusion group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient data will be in coded same packages; a designated person will provide the codes from permuted block randomization via phone. The same person will group the data at the end of the trial, and the expert will perform statistical analysis. After the results, the pocket with the randomization provider will be opened, and the data will be decrypted. The data regarding the harm and benefits of treatment groups will be provided to the patient and caregiver.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Schools of Pharmacy, Nursing and Midwifery Shahid Beheshti University of Medic
Street address
2nd floor, School of Nursing and Midwifery, Valiasr and Niayesh junction
City
Tehran
Province
Tehran
Postal code
1546815514
Approval date
2022-01-25, 1400/11/05
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1400.293
Health conditions studied
1
Description of health condition studied
Proven or suspected Infection with methicillin resistant staphylococcus aureus candidate for Vancomycin Treatment
ICD-10 code
A49.02
ICD-10 code description
Methicillin resistant Staphylococcus aureus infection, unspecified site
Primary outcomes
1
Description
Serum level of vancomycin
Timepoint
Third day of receiving vancomycin
Method of measurement
Fluorescence Polarization Immunoassays
Secondary outcomes
1
Description
Clinical response
Timepoint
5 Days
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
2
Description
Duration of ICU stay
Timepoint
1 Month
Method of measurement
Day
Intervention groups
1
Description
Intervention group: Vancomycin will be given as a loading dose of 15 mg/kg followed by a continuous infusion of 60 mg/kg over 24 hours
Category
Treatment - Drugs
2
Description
Control group: Vancomycin will be given at a dose of 15 mg/kg every 6 hours.