Background & objective : In this study we compare the regimen of the rifampin - Doxycycline with the regimen of ciprofloxacin - Doxycycline in relapse of brucellosis.
Inclusion criteria :patients with brucellosis who were elder than 17 years old Exclusion criteria : 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.
This study is a Triple bland RCT in which 90 patients with brucellosis 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:IRCT2012080310482N1
Registration date:2012-11-28, 1391/09/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-11-28, 1391/09/08
Registrant information
Name
Fashideh Didgar
Name of organization / entity
Arak University of medical sciense
Country
Iran (Islamic Republic of)
Phone
+98 86 1324 7473
Email address
dr.didgar@aracmu.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 of ciprofioxacin - Doxycycline and rifampin – Doxycycline regimens in preventing brucellosis relapse
Public title
Comparison of ciprofioxacin - Doxycycline and rifampin – Doxycycline regimens in preventing brucellosis relapse
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
Arak University of Medical Sciences
City
Arak
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
88-83-7/1
Health conditions studied
1
Description of health condition studied
Brucellosis
ICD-10 code
A23.0, A23
ICD-10 code description
Brucellosis
Primary outcomes
1
Description
relapse
Timepoint
6 , 9 , 12 months from the begining of the study
Method of measurement
physical exam
Secondary outcomes
1
Description
Drug side effects
Timepoint
During the treatment
Method of measurement
physical exam
Intervention groups
1
Description
ciprofloxacin 500mg twice aday and doycycline 100mg twice a day for two months
Category
Treatment - Drugs
2
Description
Rifampicin 300mg BID & Doxycyclin 100mg BID for two mounths