This study will be performed on 80 patients with Otomycosis accompanied ruptured tympanic membrane in ENT clinic of Ayatollah Rouhani Hospital, Babol. After sampling, the expansions of ear pus will be performed on slides, immediately; and then will be stained by Gram method. In addition; Samples will be inoculated on the blood agar and chocolate agar medium, respectively at 37 °. The negative result for bacteria and a positive direct smear result (true or false mycelium and yeast) infection will be inserted in the otomycosis. Fungi will be diagnosed by conventional methods. Patients randomly will be divided into two groups, group 1: topical clotrimazole in the ear canal, after suction clearance. Group 2: topical clotrimazole and ceftizoxime powder in the ear canal, after suction clearance. All patients re exam after 2 weeks. Both Clinical specialist and laboratory scientists will not be informed the results of them.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016082313136N4
Registration date:2016-10-13, 1395/07/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-13, 1395/07/22
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
Babol University of Medical Sciences, Vice president for research and technology
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The treatment effect of Ceftizoxime powder and clotrimazole ointment on fungal otitis media
Public title
The effect clotrimazole ointment comparison to Ceftizoxime powder and clotrimazole ointment in the treatment of patients with fungal otitis media
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with otomycosis accompanied with ruptured tympanic membrane.
Exclusion criteria: Patients with immunosuppresion; Uncontrolled diabetic patients; Bacterial otitis
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Grouping can be done using random numbers table.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Ganjafrooz St.
City
Babol
Postal code
47176-47745
Approval date
2016-05-17, 1395/02/28
Ethics committee reference number
mubabol.Rec.1395.28
Health conditions studied
1
Description of health condition studied
Middle ear infection
ICD-10 code
H66
ICD-10 code description
Acute suppurative otitis media
Primary outcomes
1
Description
The survay of clinical symptoms (pain, swelling, discharge and itching
Timepoint
2 weeks after start of treatment
Method of measurement
Clinical and Laboratory
Secondary outcomes
1
Description
Sensitivity to drug(s)
Timepoint
2 weeks after start of treatment
Method of measurement
Patient complaints and investigation by a physician
Intervention groups
1
Description
Group 1: Suction clearance and once a layer of topical Clotrimazole cream 1% made by Pars Daru pharmaceutical corporation in the ear canal
Category
Treatment - Drugs
2
Description
Group 2: Use of suction clearance and once a layer of topical clotrimazole (made by Pars Daru Pharmaceutical Corporation) and Ceftizoxime powder (made by Jaber ebn e Hayan Pharmaceutical corporation) in the ear canal by insuflation (after the use of clotrimazole)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Rouhani Hospital, Babol
Full name of responsible person
Dr. Keyvan Kiakojuri, ENT specialist
Street address
Ganj Afrooz St.
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Babol University of Medical Sciences
Full name of responsible person
Dr. Ali Bijani
Street address
Ganj Afrooz St.
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Saeid Mahdavi Omran
Position
Ph. D and Scientific Board
Other areas of specialty/work
Street address
Ganj afrooz St.
City
Babol
Postal code
4717647745
Phone
+98 11 3219 9936
Fax
Email
s.mahdavi@mubabol.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Keyvan Kiakojuri
Position
Fellow on Otolgy
Other areas of specialty/work
Street address
Ganj Afrooz St.
City
Babol
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
Ph. D and Scientific Board
Other areas of specialty/work
Street address
Ganj Afrooz St.
City
Babol
Postal code
4717647745
Phone
+98 11 3219 9936
Fax
Email
s.mahdavi@mubabol.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)