Compare therapeutic effect of Ceftazidime powder with ciprosonate drop in bacterial otitis externa
Design
Clinical trial with control group, randomized, total positive samples in 2 groups: 140 persons, beginning on April 2020
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
Inclusion criteria: All patients with bacterial otitis externa.
Exclusion criteria: Patients with suspected fungal or mixed infection as well as patients with otitis media
Intervention groups
Intervention group: After suction, 30 mg Ceftazidime powder (Exir pharmaceutical Company, Burojerd, Iran) will use for once, by insufflation in to middle ear space and the existing perforation accompanying the microscopic guide.
Control group: After suction, ciprosonate drop 0.3% (Sina Darou Pharmaceutical Company, Tehran, Iran) will use in the ear canal space for once. All patients will be visited after two weeks.
Main outcome variables
Pain; swelling; pus
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130427013136N6
Registration date:2020-02-13, 1398/11/24
Registration timing:prospective
Last update:2020-02-13, 1398/11/24
Update count:0
Registration date
2020-02-13, 1398/11/24
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
2020-04-03, 1399/01/15
Expected recruitment end date
2021-09-23, 1400/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of ceftazidime powder and Ciprosonate drop on treatment of external bacterial otitis
Public title
The efficacy of ceftazidime on bacterial otitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with bacterial otitis externa.
Exclusion criteria:
Patients who have fungal infections.
Patients who have tympanic membranous perforation
Patients with a history of ear surgery.
Patients with defective ear canal.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Investigator
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
According to inclusion and exclusion criteria, Sampling will be done by systematic random sampling way, such that patients who referred to the physician will fall into two groups, consecutively. So that the first eligible patients will be entered in group 1(Intervention) and the next one in group 2 (Control). Sampling will be continued till the desired number.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, except the secretary and laboratory colleagues, they are not aware of the placement of patients in either of these groups, the physician and patient are aware of the type of drug used.
Placebo
Not used
Assignment
Parallel
Other design features
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
2020-03-02, 1398/12/12
Ethics committee reference number
با توجه به اینکه طرح در دست بررسی در دانشکده می باشد، بنابراین تاریخ ثبت شده احتمالی است و به محض دریافت شماره و تاریخ آن اعلام خواهد شد.
Health conditions studied
1
Description of health condition studied
Bacterial otitis externa
ICD-10 code
H60.90
ICD-10 code description
Unspecified otitis externa, unspecified ear
Primary outcomes
1
Description
Pain
Timepoint
Before intervention and 2 weeks after intervention
Method of measurement
En 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
Secretion
Timepoint
Before intervention and 2 weeks after intervention
Method of measurement
Severity of secretion will determine based on the examination of the ear by the physician.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: En Intervention group: : After suction, 30 mg ciprofloxacin powder (Exir pharmaceutical company, Borujerd, 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: En Control group: After suction, ciprosonate drop 0.3% (Sina Darou Pharmaceutical company, Tehran, Iran) will use in the ear canal space for once.
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
4717647745
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
Babol University of Medical Sciences, 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
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
Fax
+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
Keyvan Kiakojouri
Position
Scientific Board (Associate Professor)
Latest degree
Specialist
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
Email
kia_ko13358@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Saeid Mahdavi Omran
Position
Scientific Board (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
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