This study is a clinical trial on 100 children aged 2 months to 12 years admitted in Pediatrics Intensive Care Unit of Kashan Beheshti Hospital with complaints of fever, tachypnea and respiratory distress in 2015. Severe pneumonia is confirmed by chest radiography. Patients with the history of pulmonary disease including asthma, documented heart disease or other chronic disease, renal disease, immunodeficiency and malnutrition or growth failure are excluded from the study. Patients randomly assign into two groups. The first group receives vancomycin prepared by Jaber Pharma Company 10 milligram per kilogram of body weight every 6 hours and the second group will receive teicoplanin prepared by Aventis Pharma Company 10 milligram per kilogram of body weight daily. Other treatment protocols for pneumonia shall be conducted in two groups. Creatinine measurements will be performed daily. Duration of fever, tachypnea and respiratory distress, adverse events (nephrotoxicity and red man syndrome) and Length of hospital stay will be recorded by the question of nurses and study of dossier.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015030111145N13
Registration date:2015-03-16, 1393/12/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-03-16, 1393/12/25
Registrant information
Name
Mohammad Reza Sharif
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0026
Email address
sharif_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2015-03-16, 1393/12/25
Expected recruitment end date
2016-03-15, 1394/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of efficacy and safety of vancomycin and teicoplanin in hospitalized children with severe pneumonia
Public title
The comparison of vancomycin and teicoplanin in treatment of hospitalized children with severe pneumonia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: children 2 months to 12 years old hospitalized in Pediatrics Intensive Care Unit of Kashan Beheshti Hospital; fever (axillary temperature 37.5° C or more); tachypnea; respiratory distress. Exclusion criteria: the history of pulmonary disease including asthma; documented heart disease or other chronic disease; renal disease; immunodeficiency; malnutrition or growth failure.
Age
From 2 months old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences, Ghotbe Ravandi Blvd, Kashan, Iran
City
Kashan
Postal code
Approval date
2015-03-05, 1393/12/14
Ethics committee reference number
5750
Health conditions studied
1
Description of health condition studied
Pneumonia
ICD-10 code
J18.9
ICD-10 code description
Pneumonia, unspecified
Primary outcomes
1
Description
Fever improvement
Timepoint
Every 6 hours
Method of measurement
Mercury thermometer with axillary method
2
Description
Tachypnea improvement
Timepoint
Daily
Method of measurement
Breathing rate
3
Description
Improvment of respiratory distress
Timepoint
Daily
Method of measurement
Observed breathing
Secondary outcomes
1
Description
Renal failure
Timepoint
Daily
Method of measurement
creatinin measurement (milligram/deciliter)
2
Description
Red man syndrome
Timepoint
During injection.
Method of measurement
Observed by nurse
3
Description
Duration of hospital stay
Timepoint
At discharge
Method of measurement
Days recorded in dossier
Intervention groups
1
Description
Intervention group 1: Intravenous infusion of vancomycin 10 mg/kg every 6 hours
Category
Treatment - Drugs
2
Description
Intervention group 2: Intravenous infusion of teicoplanin 10 mg/kg daily