Compare the efficacy of ciprofloxacin drop with a drop of levofloxacin in patients with chronic supprative otitis media (csom) clients to Zahedan Khatam-al-anbia hospital during 2016-2018
Comparing the efficacy of ciprofloxacin drop with a drop of levofloxacin in pateints with chronic suppurative otitis media clients Khatam hospital, Zahedan, Iran during 2017-2019
Design
In this study, 160 patients were randomly divided into groups of less than 20 years of age, 20 to 40 years, and 40 to 60 consecutive weeks, treated with ciprofloxacin and drops of levofloxacin. Groups are matched according to age and gender.
Settings and conduct
This study was conducted as an interventional intervention-clinical trial in ENT of Khatam-ol-Anbia Hospital in Zahedan for all patients with chronic otitis media with atherosclerosis for at least 12 weeks admitted to Khatam-ol-Anbia Hospital in Zahedan, Iran. Years 2016-2018, which are diagnosed with the history and clinical findings and are treated by an ENT doctor.
In this study, patients were randomly assigned into two treatment groups,
the first group received ciprofloxacin- betamethasone and the second group of levofloxacin- betamethasone drop.
Two weeks after treatment, all patients are evaluated to evaluate the response to treatment.
Participants/Inclusion and exclusion criteria
Entrance conditions include patients with chronic suppurative otitis media.
Intervention groups
The intervention group included recipients betamethasone drop (0.1%) (4 times daily for 2 minutes) and after discharge of ciprofloxacin drop 4% (every 6 hours 4 drops for 2-3 minutes)
The intervention group included recipients betamethasone drop (0.1%) and then levofloxacin 0.5% drop, as in the above procedure
People who participated in the study after cleaning the ear canal by suction and performing an audiometry before and after treatment to assess hearing, Every day, the entire ear canal is filled up with drops 4 times a day and completely discharged after 2 minutes
Main outcome variables
Treatment of chronic suppurative otitis media
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170731035409N2
Registration date:2018-05-05, 1397/02/15
Registration timing:retrospective
Last update:2018-05-05, 1397/02/15
Update count:0
Registration date
2018-05-05, 1397/02/15
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 0669
Email address
mostafa.nakhaei@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the efficacy of ciprofloxacin drop with a drop of levofloxacin in patients with chronic supprative otitis media (csom) clients to Zahedan Khatam-al-anbia hospital during 2016-2018
Public title
Compare the efficacy of ciprofloxacin drop with a drop of levofloxacin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Not use cigarette drugs
Not pregnancy
Lack of hospitalization in the last three weeks
No history of other ear diseases and ear surgery
The recent lack of topical or systemic antibiotics (last three weeks)
Absence of viral infections in the last three weeks
Insensitivity to the fluoroquinolone group
Lack of simultaneous use of systemic drugs with auto-toxic effects
Non-fungal infection of the outer and middle ear simultaneously
Do not use concomitant immunosuppressive drugs
Exclusion criteria:
Patients who did not complete the prescribed treatment for any reason during the study
Use of other medicines for treatment
Exposed to ototoxic materials
Age
To 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
The method of randomization is such that after the arrival of patients, patients are classified into two groups according to gender and age matched
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zahedan University Ethics Committee
Street address
No. 47, Alborz Ave., Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817987741
Approval date
2017-04-16, 1396/01/27
Ethics committee reference number
IR.ZAUMS.REC.1396. 11
Health conditions studied
1
Description of health condition studied
Chronic Suppurative Otitis media
ICD-10 code
H66.3
ICD-10 code description
Chronic suppurative otitis media NOS
Primary outcomes
1
Description
Recovery situation
Timepoint
2 weeks after the first visit
Method of measurement
The symptoms of the illness that the patient is referring to include pain, discharge, and hearing loss are resolved.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients receiving betamethasone drop 0.1% (4 times daily for 2 minutes) and after discharge of ciprofloxacin 0.4% (every 6 hours 4 drops for 2-3 min) for 2 weeks
Category
Treatment - Drugs
2
Description
Intervention group: Patients receiving betamethasone drop 0.1% (4 times daily for 2 minutes) and after discharge of Levofloxacin 0.5% (every 6 hours 4 drops for 2-3 min) for 2 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam-Ol-Anbia Hospital
Full name of responsible person
Dr Reza Ghariby
Street address
Khatam-Ol-Anbia Hospital, Jam e Jam Avenue, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3323 9762
Email
khatamhospital_zah@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr Hushang Rafighdust
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5715
Email
public@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Dr Reza Ghariby
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3322 0501
Email
Khatamhospital_zah@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr Reza Ghariby
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3322 0501
Email
khatamhospital_zah@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr Reza Ghariby
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816746175
Phone
+98 54 3329 5718
Email
khatamhospital_zah@yahoo.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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
proposal
When the data will become available and for how long
2018
To whom data/document is available
public
Under which criteria data/document could be used
In order to do research
From where data/document is obtainable
Zahedan University of Medical Sciences website
What processes are involved for a request to access data/document
By accessing the relevant sites, you can access the materials.