The aim of this study is to compare therapeutic effect of ciprofloxacin powder with ciprofloxacin drop in chronic bacterial otitis media
Design
Clinical trial with control group, randomized, total positive samples in 2 groups: 80 persons, beginning on October 2018
Settings and conduct
Patients with ear problems refereed to ENT department of Ayatollah Rouhani Hospital in Babol, Iran. At the clinic, patients are examined by a specialist in otolaryngology. A questionnaire including demographic and disease information is filled out for all patients who have inclusion criteria. Two samples of pus and ear discharge will be taken by the specialist (one for direct examination and the other for culture). After suction, the patient will be randomly assigned to one of the intervention or control groups. They are treated according to the assigned group. Samples will be sent to the mycology and microbiology laboratories in Babol University of Medical Sciences. Laboratory colleagues without being aware of grouping will perform the necessary tests to confirm the organism causing the disease and then obtained data will be analyzed.
Participants/Inclusion and exclusion criteria
All patients with chronic bacterial otitis media will enter the study.
Patients with suspected mixed infection as well as patients with external otitis infection will exclude in the study
Intervention groups
Intervention group: After suction, 30 mg ciprofloxacin powder (Ronak pharmaceutical company, Kaveh industrial town, Iran) will use for once, by insufflation in to middle ear space and the existing perforation accompanying the microscopic guide.
Control group: After suctioning of the ear canal, 3 drops of ciprofloxacin 0.3% (Sina Darou Pharmaceutical Company, Tehran, Iran) are poured once into the ear canal.
All patients will be visited after two weeks.
Main outcome variables
Pain; swelling; discharge
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130427013136N7
Registration date:2020-03-11, 1398/12/21
Registration timing:registered_while_recruiting
Last update:2020-03-11, 1398/12/21
Update count:0
Registration date
2020-03-11, 1398/12/21
Registrant information
Name
Saeid Mahdavi Omran
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1219 9936
Email address
s.mahdavi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of therapeutic effect of ciprofloxacin powder and drops in the chronic bacterial otitis media
Public title
The effects of ciprofloxacin on the treatment of bacterial otitis media
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with chronic bacterial otitis media
Exclusion criteria:
Suspected Patients to mixed bacterial and fungal otitis
Suspected Patients to otomycosis
patients with external otitis
patients without rupture of the eardrum
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Investigator
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
According to inclusion and exclusion criteria, patients who referred to the physician will fall into two groups, consecutively. So that the first eligible patients will be entered in group 1 and the next one in group 2. Sampling will be continued till the desired number.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the primary specialist is informed about the type of drug, due to the apparent difference between the packaging and its application of them, but another otolaryngologist will be evaluate the patients at the follow-up stage.Therefore, the judgment about the effectiveness of these drugs will be based only on the clinical findings of the disease at this stage, by the second specialist. Laboratory experts who make the final diagnosis according to direct examination and culture on media results, also will perform the necessary tests according to a patient code; and they are not aware of the patient group. All patients also aware of the type of treatment, depending on the form and how the drug is used.
Placebo
Not used
Assignment
Parallel
Other design features
Ciprofloxacin powder is not available in Iran's drug store, thus the tablet form of this drug is converted into powder by a pharmacologist.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
School of Medicine, Babol University of Medical Sciences, University Square, Ganj afrouz Street
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2018-02-26, 1396/12/07
Ethics committee reference number
MUBABOL.HRI.REC.1396.202
Health conditions studied
1
Description of health condition studied
Chronic bacterial otitis media
ICD-10 code
H65.3
ICD-10 code description
Chronic mucoid otitis media
Primary outcomes
1
Description
Pain
Timepoint
Before intervention and 2 weeks after intervention
Method of measurement
Severity of pain will determined by the patient's expression or pain index (Visual Analog Scale-VAS) which are between 0-10.
2
Description
Swelling
Timepoint
Before intervention and 2 weeks after intervention
Method of measurement
Severity of swelling will determine based on the examination of the ear by the physician.
3
Description
Discharge
Timepoint
Before intervention and 2 weeks after intervention
Method of measurement
Severity of discharge will determine based on the examination of the ear by the physician.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After suction, 30 mg ciprofloxacin powder (Ronak pharmaceutical company, Kaveh industrial town, Iran) will use for once, by insufflation in to middle ear space and the existing perforation accompanying the microscopic guide.
Category
Treatment - Drugs
2
Description
Control group: After suctioning of the ear canal, 3 drops of ciprofloxacin 0.3% (Sina Darou Pharmaceutical Company, Tehran, Iran) are poured once into the ear canal.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
ENT clinic, Aytollah Rouhani Hospital
Full name of responsible person
Dr Keyvan Kiakojuri
Street address
ENT Clinic, Aytollah Rouhani Hospital, Ganj Afrooz st.
City
Babol
Province
Mazandaran
Postal code
47176-47745-
Phone
+98 11 3223 8301
Fax
+98 11 3219 9936
Email
info@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Reza Ghadimi
Street address
School of Medicine, Babol University of Medical Sciences, University Square, Ganj afrouz Street
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9936
Email
rezaghadimi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Saeid Mahdavi Omran
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Mycology
Street address
School of Medicine, Babol University of Medical Sciences, University Square, Ganj afrouz Street
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9936
Email
s.mahdavi@mubabol.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
سعید مهدوی عمران
Position
Associate Professor
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
School of Medicine, Babol University of Medical Sciences, University Square, Ganj afrouz Street
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9936
Fax
Email
kia_ko13358@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Saeid Mahdavi Omran
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Microbiology
Street address
School of Medicine, Babol University of Medical Sciences, University Square, Ganj afrouz Street
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9936
Email
s.mahdavi@mubabol.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD