Background & objective : Brucellosis is one of the endemic diseases in Iran which has worldwide dissemination and is associated with chronic disabilities in humans. Combination therapy of brucellosis leads to recovery of symptoms, shortening of symptomatic interval and decrease in relapse rate and drug resistance.
Considering the usage of rifampin in treatment of tuberculosis and necessity of an alternative treatment in regions in which both tuberculosis and brucellosis are endemic, in this study we compare the standard regimen of the WHO rifampin - Doxycycline with the regimen of ciprofloxacin - Doxycycline in treatment of brucellosis.
Materials & Methods : This study is a RCT in which 90 patients with brucellosis who were elder than 17 years old and Negative inclusion criterial : pregnancy;age less than 17 years;endocarditis - meningitis ; spondy lities esophagitis ; consumption of ocp and phenytion; history of brucellosis (relapse) antimicrobial therapy for more than 7 day befor attending bad general condition attended between 1384- 1387 in the Two clinics of infectious disease in Arak university of medical sciences were evaluated on the basis of Inclusion criteria's.
The patients were randomly divided in two groups : Patients in DR groups, receiving Doxycycline 100 mg twice a day and rifampin 300 mg Bid daily for eight weeks, and the CD group , receiving Doxycycline 100 mg twice a day and ciprofloxacin 500 mg twice a day foot eight weeks.
The patients were checked for the relief of symptoms , drug side effects and labratory findings during the treatment .pationts evaluated for relapse , failure of treatment, drug side effects.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201103146056N1
Registration date:2012-03-10, 1390/12/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-03-10, 1390/12/20
Registrant information
Name
Nader Zarinfar
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1224 1411
Email address
zarinfar@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2006-02-09, 1384/11/20
Expected recruitment end date
2009-02-08, 1387/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between efficacy of ciprofioxacin - Doxycycline and rifampin – Doxycycline regimens in treatment of brucellosis
Public title
Comparison between efficacy of ciprofioxacin - Doxycycline and rifampin – Doxycycline regimens in treatment of brucellosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : patients with brucellosis in basis of clinical, epidemiological and serologic criteria, attended in the clinics of infectious disease in Arak university of medical sciences and age more than 17 years old.
Excusion criteria : pregnancy; age less than 17 years; endocarditis - meningitis ; spondy lities, esophagitis ; consumption of oral contraceptives or phenytion; history of brucellosis (relapse), antimicrobial therapy for more than 7 days befor attending; intolerance for oral medication and no desire for patipicating.
Age
From 17 years old to 76 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Aak University of Medical Sciences
Street address
Aak University of Medical Sciences, Alamalhoda ave.
City
Arak
Postal code
Approval date
2006-02-06, 1384/11/17
Ethics committee reference number
88-83-7/1
Health conditions studied
1
Description of health condition studied
Brucellosis
ICD-10 code
A23.0
ICD-10 code description
Brucellosis due to Brucella melitensis
Primary outcomes
1
Description
Clinical improvement
Timepoint
At the beginning of the study - second & third & and nine months serologic test in second & sixth& mounths
Method of measurement
Patients' history and physical exam and serologic results(clinical , wrigth , 2ME , serologic)
Secondary outcomes
1
Description
Relapse
Timepoint
Sixth & ninth mounths from the begining of the study
Method of measurement
Clinical improvment and serology
2
Description
Failure of the treatment
Timepoint
Three mounth
Method of measurement
Clinical improvment and serology
3
Description
Drug side effects
Timepoint
During the treatment
Method of measurement
Clinical assessment
Intervention groups
1
Description
In case group : ciprofloxacin 500mg twice aday and doycycline 100mg twice a day for two months
Category
Treatment - Drugs
2
Description
In control group Rifampicin 300mg BID & Doxycyclin 100mg BID for two mounths
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valieasr hospital
Full name of responsible person
Assistant professor Arak university of medical sciences, Infectious disease specialist
Street address
valieasr hospital Arak
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Davood hekmatpoor
Street address
Arak Meydan basij
City
Arak
Grant name
31004
Grant code / Reference number
1107
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr. Farshideh Didgar
Position
Infectious disease specialist
Other areas of specialty/work
Street address
Arak - Valieasr hospital-
City
Arak
Postal code
3814957558
Phone
+98 86 1224 1411
Fax
+98 86 1224 1411
Email
dr.didgar@arakmu.ac.ir
Web page address
arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Farshideh Didgar
Position
Infectious disease specialist
Other areas of specialty/work
Street address
Arak Valieasr hospital
City
Arak
Postal code
3814957558
Phone
+98 86 1224 1411
Fax
+98 86 1224 1411
Email
zarinfar@arakmu.ac.irfdidgar@yahoo.com
Web page address
arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Farshideh Didgar
Position
Infectious disease specialist
Other areas of specialty/work
Street address
Arak Valieasr hospital
City
Arak
Postal code
3814957558
Phone
+98 86 1224 1411
Fax
+98 86 1224 1411
Email
zarinfar@arakmu.ac.irfdidgar@yaho.com
Web page address
arakmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)