This was a single blind clinical trial on 78 patients with acute bacterial sinusitis.Beacause of continues changing in bacterial resistance to drugs these studise are necessary.This study has done to compare the effect of Azithromycin and Amoxicillin-Clavulanate on treatment of acute bacterial sinusitis. Inclusion criterias were at least two major or one major and two minor criterias for diagnosis of acute bacterial sinusitis. Exclusion criterias were: choronic sinusitis; recurrent sinusitis; drugs consumption and... . One group was administered Azithromycin500mg daily for three days and another group was administered Amoxicillin-Clavulanate 625 mg three times daily for ten days.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201401046252N5
Registration date:2014-02-11, 1392/11/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-02-11, 1392/11/22
Registrant information
Name
Soroush Amani
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1226 4834
Email address
samani@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Sciences
Expected recruitment start date
2013-04-04, 1392/01/15
Expected recruitment end date
2013-09-21, 1392/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparsion of efficacy and safety of Azithromycin and Amoxicillin-Clavulante in the treatement of acute bacterial sinusitis in adults.
Public title
Comparison effect of Azithromycin and Amoxiclave in treatment of acute sinusitis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Having at least two major or one major and two minor sinusitis criterias that have lasted 7to28days. Major criterias included: pain or feeling of fullness in face; nasal obstruction; nasal or postnasal discharge; anosmia or hyposmia; fever. Minor criterias included: headache; halitosis; fatigue; toothache; cough; otalgia or feeling of fullness in the ears.
Exclusion criterias: choronic sinusitis; recurrent sinusitis; anatomic deformitis(severe septal deviation; cleft palate); choronic disease(hepatic; renal; cardiac and ashtma); pregnancy and breast feeding; allergy to drugs; cilliary dysfunction; cystic fibrosis; HIV infection; diabetes; using of steroid; complication of sinusitis like orbital cellulitis; using of antibiotics in last 30 days; having less12 years old or more than 65 years old.
Age
From 12 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
78
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahrekord University of Medical Sciences
Street address
Kashani Avenue, Shahrekord
City
Shahrekord
Postal code
8815713471
Approval date
2013-09-15, 1392/06/24
Ethics committee reference number
1392-6-24
Health conditions studied
1
Description of health condition studied
Sinusitis
ICD-10 code
JO1.9
ICD-10 code description
Diseases of respiratory system
Primary outcomes
1
Description
Facial pain
Timepoint
First day- fifth day- tenth day
Method of measurement
Visual
2
Description
Nasal obstruction
Timepoint
First day- fifth day- tenth day
Method of measurement
Visual
3
Description
Nasal or postnasal discharge
Timepoint
First day- fifth day- tenth day
Method of measurement
Visual
4
Description
Anosmia or hyposmia
Timepoint
First day- fifth day- tenth day
Method of measurement
Visual
5
Description
Fever
Timepoint
First day- fifth day- tenth day
Method of measurement
With termometer
Secondary outcomes
1
Description
Headache
Timepoint
First day- fifth day- tenth day
Method of measurement
Visual
2
Description
Halitosis
Timepoint
First day- fifth day- tenth day
Method of measurement
Visual
3
Description
Fatigue
Timepoint
First day- fifth day- tenth day
Method of measurement
Visual
4
Description
Toothache
Timepoint
First day- fifth day- tenth day
Method of measurement
Visual
5
Description
Cough
Timepoint
First day- fifth day- tenth day
Method of measurement
Visual
6
Description
Otalgia or feeling of fullness in ears
Timepoint
First day- fifth day- tenth day
Method of measurement
Visual
7
Description
Diarrhea
Timepoint
First day- fifth day- tenth day
Method of measurement
Visual
8
Description
Vomiting
Timepoint
First day- fifth day- tenth day
Method of measurement
Visual
Intervention groups
1
Description
In first group Azithromycin was administered 500mg daily for three days.
Category
Treatment - Drugs
2
Description
In second group Amoxicillin-Clavulante was administered 625mg three times daily for ten days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahrekord kashani hospital
Full name of responsible person
Soroush Amani MD
Street address
Kashani hospital,Shariati Avenue,Shahrekord
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Dr Mahmood Mobashery
Street address
Shahrekord University of Medical Sciences, Kashani Aveni ue,Shahrekord
City
Shahrekord
Grant name
ندارد
Grant code / Reference number
Do not have
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord 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
Shahrekord Unhversity of Medical Sciences
Full name of responsible person
Soroush Amani MD
Position
Otolaryngologist
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences,Kashani Avenue,Shahrekord
City
Shahrekord
Postal code
8815713471
Phone
+98 38 1333 0061
Fax
+98 38 1334 3004
Email
info@Skums.ac.ir
Web page address
http://www.SKUMS.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Soroush Amani MD
Position
Otolaryngologist
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences,Kashani Avenue,Shahrekord
City
Shahrekord
Postal code
8815713471
Phone
+98 38 1333 0061
Fax
+98 38 1334 3004
Email
info@Skums.ac.ir
Web page address
http://www.SKUMS.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Soroush Amani MD
Position
Otolaryngologist
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences,Kashani Avenue,Shahrekord
City
Shahrekord
Postal code
8815713471
Phone
+98 38 1333 0061
Fax
+98 38 1334 3004
Email
info@Skums.ac.ir
Web page address
http://www.SKUMS.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)