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Clinical trial of the effectiveness of comparing the treatment of acute otitis media with Amoxicillin and watchful waiting in 6 months to 6 years old children

Protocol summary

Study aim
Determining the effect of Amoxicillin and watchful waiting in 6 months to 6 years old children
Design
Clinical trial with control group, with parallel groups, simple blind and simple randomization. The sample size is estimated 200 people in each group.
Settings and conduct
In this clinical trial 6 months to 6 years old children referring to Infectious diseases clinic of Bouali hospital of Sari were evaluated prospectively. Only data analyser was blinded
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 6 months to 6 years, Acute otitis media with signs started within 48 hours, Not having severe symptoms and ear otorrhea, Unilateral or bilateral involvement Exclusion criteria: Severe otalgia, Fever higher than 39 oc, Underlying diseases such as immunodeficiency, Amoxicillin intake in the last 30 days, Concurrent conjunctivitis, Ear otorrhea
Intervention groups
For the intervention group, 80 mg/kg/day, Amoxicillin Suspension, made by Farabi Company with brand name of "Faramox BD" or Amoxicillin-Clavulanate Suspension made by the same Company with brand name of Pharmentin BD, with the same dose in children who receive Amoxicillin one month ago was used for 7 to 10 days, and the control group was followed and monitored without antibiotic treatment and symptoms were evaluated.
Main outcome variables
Fever, otalgia, mastoiditis and ottorhea were evaluated at first and third day following treatment. Middle ear effusion and frequency of acute otitis media were evaluated in one and three months after treatment. Any adverse drug reactions including diarrhea, vomiting and allergic reactions were also recorded on the checklist.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20111224008507N2
Registration date: 2018-07-09, 1397/04/18
Registration timing: retrospective

Last update: 2018-07-09, 1397/04/18
Update count: 0
Registration date
2018-07-09, 1397/04/18
Registrant information
Name
Mohammad Sadegh Rezai
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3334 2334
Email address
rezai@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2018-06-21, 1397/03/31
Actual recruitment start date
2017-08-23, 1396/06/01
Actual recruitment end date
2018-06-21, 1397/03/31
Trial completion date
empty
Scientific title
Clinical trial of the effectiveness of comparing the treatment of acute otitis media with Amoxicillin and watchful waiting in 6 months to 6 years old children
Public title
Comparing the treatment of acute otitis media with Amoxicillin and watchful waiting in 6 months to 6 years old children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 6 months to 6 years Acute otitis media with signs started within 48 hours Not having severe symptoms and ear otorrhea Unilateral or bilateral involvement
Exclusion criteria:
Severe otalgia Fever higher than 39 degrees Underlying diseases such as immunodeficiency (except asthma and allergy) Amoxicillin intake in the last 30 days Concurrent conjunctivitis Ear otorrhea
Age
From 6 months old to 6 years old
Gender
Both
Phase
3
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 200
Actual sample size reached: 375
Randomization (investigator's opinion)
Randomized
Randomization description
After obtaining informed consent for randomization form parents of children, patients were placed in intervention (amoxicillin) and control group (watchful waiting) by entering in blocks of four and randomized division
Blinding (investigator's opinion)
Single blinded
Blinding description
Data analyser was blinded
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Vice chancellor for Research, Moallem square, Sari
City
Sari
Province
Mazandaran
Postal code
47128-55689
Approval date
2017-08-01, 1396/05/10
Ethics committee reference number
IR.MAZUMS.REC.1395.2489

Health conditions studied

1

Description of health condition studied
Otitis media
ICD-10 code
H65.1
ICD-10 code description
Other acute nonsuppurative otitis media

Primary outcomes

1

Description
fever
Timepoint
At the beginning of the study (before the intervention), three days after treatment
Method of measurement
Thermometer

2

Description
Otalgia
Timepoint
At the beginning of the study (before the intervention), three days after treatment
Method of measurement
Observation

3

Description
Mastoiditis
Timepoint
At the beginning of the study (before the intervention), three days after treatment
Method of measurement
Examination

4

Description
Middle ear effusion
Timepoint
At the beginning of the study (before the intervention), three days after treatment
Method of measurement
Examination

Secondary outcomes

1

Description
Frequency of acute otitis media
Timepoint
One and three months after treatment
Method of measurement
Observation

2

Description
Middle ear effusion
Timepoint
One and three months after treatment
Method of measurement
Examination

Intervention groups

1

Description
Intervention group: For the intervention group, 80 mg/kg/day Amoxicillin suspension manufactured by Farabi co. with brand name of Faramox BD will be given for at least 7 days.
Category
Treatment - Drugs

2

Description
Control group: The control group is followed up without antibiotic therapy and with monitoring and evaluation of symptoms. In this group, only patients who are allowed not to use antibiotic treatment and can be expected with care are enrolled under AOM's guideline.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Bouali Hospital
Full name of responsible person
Mohammadsadegh Rezai
Street address
Bouali Hospital, Pasdaran boulevard, Sari
City
Sari
Province
Mazandaran
Postal code
47128-55689
Phone
+98 11 3334 2334
Email
rezai@mazums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saidi
Street address
Vice chancellor for Research, Moallem square, Sari
City
Sari
Province
Mazandaran
Postal code
47128-55689
Phone
+98 11 3334 2334
Email
msaidi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari 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
Mazandaran University of Medical Sciences
Full name of responsible person
Ensieh Talaei
Position
Pediatrics' resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Bouali Hospital, Pasdaran boulevard, Sari
City
Sari
Province
Mazandaran
Postal code
47128-55689
Phone
+98 11 3334 2334
Email
nasimmeh62@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mohammadsadegh Rezai
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Bouali Hospital, Pasdaran Boulevard, Sari
City
Sari
Province
Mazandaran
Postal code
47128-55689
Phone
+98 11 3334 2334
Email
drmsrezaii@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ensieh Talaei
Position
Pediatric Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Bouali Hospital, Pasdaran Boulevard
City
Sari
Province
Mazandaran
Postal code
47128-55689
Phone
+98 11 3334 2334
Email
nctalaie@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the data is available
When the data will become available and for how long
En starting in January 2020
To whom data/document is available
All people
Under which criteria data/document could be used
Nothing
From where data/document is obtainable
Contact Dr. Ensieh Talaei. E-mail: nctalaei@gmail.com
What processes are involved for a request to access data/document
After a call, information is sent within a few days
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