1-Objectives: The aim of this study was to compare the efficacy of single dose and three days course of Cefixime in women with uncomplicated acute cystitis.
2-Design: The method of this study is 2to3 phases of clinical trial.
3- Setting and conduct: The subjects were referred to urologic and gynecologic clinic at Bou Ali Hospital in Tehran (Iran)due tourinary tract diseases symptoms.
4- Participants including major eligibility criteria:70 eligible women referring to following criteria had been selected: Inclusion criteria : fertility age( 50-15 age); fully functional immunity system
Exclusion criteria : menopause; pregnancy; abnormality of Urinary Tract; history of Urinary Tract surgery& Sondage ; systemic symptoms (e.g,fever, lumbar pain); use of Intra Uterine Device; sensitivity to Penicillins&Cephalosperins; history of Diabetis Mellitus
5- Intervention: subjects had been randomly divided in two groups (35 persons). The first group (Intervention group) was prescribed one 800 mg dose of Cefixime and the 2nd group (Control group) was treated with 400mg/day Cefixime for 3 days.
6- Main outcome variables: The main outcome which has been assessed was the positiveness of urine culture test after one and two weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204189505N1
Registration date:2013-01-01, 1391/10/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-01-01, 1391/10/12
Registrant information
Name
Fatemeh Mohammadyari
Name of organization / entity
Islamic Azad univertsity Tehran Medical Branch
Country
Iran (Islamic Republic of)
Phone
+98 220066607009821
Email address
fmohammadyari@iautmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Islamic Azad University Tehran Medical Branch
Expected recruitment start date
2007-03-20, 1385/12/29
Expected recruitment end date
2008-03-19, 1386/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of single dose and three-day course of Cefixime in women with acute cystitis
Public title
Comparison of single dose and three-day course of Cefixime in women with acute cystitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : fertility age( 50-15 age); fully functional immunity system
Exclusion criteria : menopause; pregnancy; abnormality of Urinary Tract; history of Urinary Tract surgery& Sondage ; systemic symptoms (e.g,fever, lumbar pain); use of Intra Uterine Device; sensitivity to Penicillins&Cephalosperins; history of Diabetis Mellitus
Age
From 15 years old to 50 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
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
Ethic committee of Vice chancellor for research,Islamic Azad University Tehran Medical Branch
Street address
Tehran Medical Branch , Islamic Azad University, khaghani st, shariati Ave , Tehran, Iran
City
Tehran
Postal code
19168
Approval date
2007-04-21, 1386/02/01
Ethics committee reference number
2628
Health conditions studied
1
Description of health condition studied
Acute Cystitis
ICD-10 code
N30.0
ICD-10 code description
Acute Cystitis
Primary outcomes
1
Description
positiveness of urine culture test
Timepoint
after one and two weeks from finishing the prescribed antibiotics.
Method of measurement
Urine Culture test
Secondary outcomes
empty
Intervention groups
1
Description
The first group (Intervention group) was prescribed one dose/ 800 mg of Cefixime .
Category
Treatment - Drugs
2
Description
The 2nd group ( Control group) was treated with 400mg/day Cefixime for 3 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Urologic and Gynecologic clinic at Boo Ali Hospital in Tehran (Iran)
Full name of responsible person
Fatemeh Mohammadyari
Street address
Damavand St., Imam Hossein Sq., Tehran-Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Islamic Azad University Tehran Medical Branch
Full name of responsible person
Mr Naghipour
Street address
Tehran Medical Branch , Islamic Azad UniversityT, khaghani st, shariati Ave , Tehran, Iran
City
Tehran
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, Islamic Azad University Tehran Medical Branch
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
Islamic Azad university Tehran Medical Branch
Full name of responsible person
Dr Fatemeh Mohammadyari
Position
Gynecologist-Assistant professor ofIslamic Azad university Tehran Medical Branch
Other areas of specialty/work
Street address
Damavand St., Imam Hossein Sq., Tehran-Iran
City
Tehran
Postal code
Phone
+98 21 3334 8036
Fax
Email
fmohammadyari@iautmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad university Tehran Medical Branch
Full name of responsible person
Dr Fatemeh Mohammadyari
Position
Gynecologist-Assistant professor of Islamic Azad university Tehran Medical Branch
Other areas of specialty/work
Street address
Damavand St., Imam Hossein Sq., Tehran-Iran
City
Tehran
Postal code
Phone
+98 21 3334 8036
Fax
Email
fmohammadyari@iautmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University Tehran Medical Branch
Full name of responsible person
Dr Fatemeh Mousavi
Position
Community Medicine Specialist, Associate professor of Islamic Azad University Tehran Medical Branch
Other areas of specialty/work
Street address
Tehran Medical Branch , Islamic Azad University, khaghani st, shariati Ave , Tehran, Iran
City
Tehran
Postal code
19395
Phone
+98 21220066607
Fax
ati35983@yahoo.com
Email
ati35983@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)