Effectiveness of Oral Acyclovir in Treatment of Infectious Mononucleosis in Children, Iran, Gorgan, Taleghani Hospital ,2021; A Double Blind Placebo Controlled Clinical Trial
Reduce the duration of treatment and the severity of the disease
Design
Randomized, superiority, parallel group trial design of 46 patients with blinded outcome assessment. Randomization with block randomization method,
Settings and conduct
This double-blind clinical trial study was performed on children with infectious mononucleosis admitted to Taleghani Children's Hospital in Gorgan in 2021.
Participants/Inclusion and exclusion criteria
Inclusion criteria: children (1 to 16 years old) who have symptoms of the disease including sore throat, lymphadenopathy and fatigue; symptoms begin within the last 3 days; fever 38 c.
Exclusion criteria: no need for hospitalization; underlying diseases such as diabetes and asthma; antiviral and steroid treatment for the past 2 weeks; serum creatinine higher than 1.6.
Intervention groups
Intervention group: Acyclovir 80 mg / kg / 24hr recipients in 4 divided doses for 5 days (acyclovir tablets made by Amin Pharma, Iran).
Control group: starch tablet receivers for 5 days just like intervention groups( barij sansei,Iran)
Main outcome variables
Reduce the duration of treatment and the severity of the disease
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201201049554N1
Registration date:2021-02-21, 1399/12/03
Registration timing:prospective
Last update:2021-02-21, 1399/12/03
Update count:0
Registration date
2021-02-21, 1399/12/03
Registrant information
Name
Abdolmotalleb Mazidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3222 7720
Email address
dr.mazidi@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-05, 1399/12/15
Expected recruitment end date
2021-05-21, 1400/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Oral Acyclovir in Treatment of Infectious Mononucleosis in Children, Iran, Gorgan, Taleghani Hospital ,2021; A Double Blind Placebo Controlled Clinical Trial
Public title
Effectiveness of Oral Acyclovir in Treatment of Infectious Mononucleosis in Children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children (1 to 16 years old) who have symptoms of the disease including sore throat, lymphadenopathy and fatigue
Symptoms begin within the last 3 days
fever 38 c
Exclusion criteria:
No need for hospitalization
Underlying diseases such as diabetes and asthma
Antiviral and steroid treatment for the past 2 weeks
serum creatinine higher than 1.6
Age
From 1 year old to 16 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
We use the block randomization method to randomize subjects into groups that result in equal sample sizes.
We use the block size 4. From the following blocks, first select 1 by accident and divide the samples into 2 groups according to the order and fill the blocks
A for acyclovir and B placebo
Blinding (investigator's opinion)
Triple blinded
Blinding description
This study is double-blind and the medical examiner resident, medication provider and patients would not know about the type of treatment.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Golestan University of Medical Sciences
Street address
Golestan University of Medical Sciences, Gorgan,Shastkola road, Philosophical Higher Education Complex
City
Gorgan
Province
Golestan
Postal code
4934174515
Approval date
2021-01-24, 1399/11/05
Ethics committee reference number
IR.GOUMS.REC.1399.345
Health conditions studied
1
Description of health condition studied
Infectious Mononucleosis
ICD-10 code
B27.10
ICD-10 code description
Cytomegaloviral mononucleosis, without complications
Primary outcomes
1
Description
Reduce the hospitalization duration
Timepoint
The patient's general condition and the presence of respiratory distress will be assessed daily after starting treatment
Method of measurement
Medical assessment and physical examination
2
Description
Reduce severity of disease
Timepoint
The presence of fever, exudative sore throat, respiratory distress, stridor is evaluated daily after starting treatment
Method of measurement
Medical assessment and physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Acyclovir 80 mg / kg / 24hr recipients in 4 divided doses for 5 days (acyclovir tablets made by Amin Pharma, Iran)
Category
Treatment - Drugs
2
Description
Control group: Placebo group (starch placebo product of Barij Essential Company) in 4 divided doses for 5 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Dr. Jabar Parhiz
Street address
Philosophical Higher Education Complex, Shast Kola Road, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3220 2565
Email
drparhiz.jbr@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Honarvar
Street address
Philosophical Higher Education, Shast Kola Road, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 1660
Email
info@goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Abdolmotaleb Mazidi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Golestan University of Medical Sciences, Shast Kola Road, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3220 2565
Email
drmazidimd@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Abdolmotaleb Mazidi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Golestan University of Medical Sciences, Shast Kola Road, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3220 2565
Email
drmazidimd@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Abdolmotaleb Mazidi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Golestan University of Medical Sciences, Shast Kola Road, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3220 2565
Email
drmazidimd@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available