Comparison of the efficacy of gentamicin for 7 days plus doxycyclinee for 45 days versus the same regime plus refampin for 45 days in the treatment of human brucellosis
Nowadays doxycycline plus rifampin or doxycycline in combination with an aminoglycoside is used for the treatment of human brucellosis .But in many cases it is observed relapse. The aim of this study was to compare of the efficacy of gentamicin for 7 days plus doxycyclinee for 45 days versus the same regime plus refampin for 45 days in the treatment of human brucellosis .It will be investigated Brucella DNA by PCR, before and after treatment .Therefore People with brucellosis are employed.Inclusion criteria included: the patient had not received treatment, and also clinical signs and par clinical signs including, blood cultures, Wright test , 2ME and combs wright, must confirm illness in given.Exclusion criteria included: pregnant women, Children younger than 8 year or endocarditis, meningitis and spondylitis patients. Blood sampling is taken before treatment from responders to evaluate ِDNA of Brucella bacteria with PCR technique. Patients are randomly divided into two 80 patients groups. The first group receives Gentamicin 4-5mg/kg for a week, Doxcycycline 100mg/bid for 45 days and moreover second one receives daily Rifampin600-900 mg for 45days.All of examinations will be repeated and compared after 6 weeks and 6 months at the end of treatment, respectively.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014041217230N1
Registration date:2014-05-06, 1393/02/16
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-05-06, 1393/02/16
Registrant information
Name
Zahra Moulana
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1220 7918
Email address
z.molana@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Affairs of Babol University of Medical Sciences
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2015-05-22, 1394/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of gentamicin for 7 days plus doxycyclinee for 45 days versus the same regime plus refampin for 45 days in the treatment of human brucellosis
Public title
New regimen of therapy in the treatment of human Brucellosis
Purpose
Treatment
Inclusion/Exclusion criteria
After providing adequate information eligible patients volenteer will be enrolled in the study.
Inclusion criteria:Patients who have received no treatment,Clinical signs and positive Blood culture,positive serological tests such as Wright and 2ME and Coombs Wright.
Exclusion criteria : pregnant women and children less than 8 years, patients with endocarditis, meningitis or spondylitis , Negative PCR tests are also excluded
Age
From 8 years old to 130 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Babol University of Medical Sciences
Street address
University Sq Ave,Ganje Afrooze
City
Babol
Postal code
4717641367
Approval date
2014-04-23, 1393/02/03
Ethics committee reference number
304018/11/ژ/پ
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
DNA of Brucella bacteria
Timepoint
Three sections: in first day of the study, end of the sixth week, end of the sixth month
Method of measurement
PCR
2
Description
Brucella bacteria
Timepoint
Three sections: in first day of the study, end of the sixth week, end of the sixth month
Method of measurement
Blood culture
3
Description
Antibody of serum
Timepoint
Before treatment, 6 weeks after begining of treatment, 6months after end of treatment
Method of measurement
Wright test, 2ME, Coombs
Secondary outcomes
empty
Intervention groups
1
Description
Gentamicin 4-5 mg /kg (IM)for one week and doxycycline 100 mg/bid (oral) for 45 days, plus rifampin 600-900 mg /daily( oral) for 45 days orally.
Category
Treatment - Drugs
2
Description
Gentamicin 4-5 mg /kg for one week as an injection and doxycycline 100 mg/bid for 45 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Rouhani Hospital, Babol University of Medical Sciences
Full name of responsible person
Street address
Ganje Afrooze Ave. University SQ
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Ali Bijani
Street address
Ganje Afrooze Ave.Babol University of Medical Sciences
City
Babol
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
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
Babol University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Hassanjani Roshan
Position
Professor and head of the Department of Infectious Diseases
Other areas of specialty/work
Street address
Ganjafroz Avenue,Babol University of Medical Sciences,Faculty of Medicine
City
Babol
Postal code
4717641367
Phone
+98 11 1220 7918
Fax
+98 11 1220 7918
Email
hagar2q@yahoo.ca; z.molana@mubabol.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Hassanjani Roshan
Position
Professor and head of the Department of Infectious Diseases
Other areas of specialty/work
Street address
Infectious Diseases and Tropical Medicine Research Center,Faculty of Medicine, Babol University of Medical Sciences,
City
Babol
Postal code
4717641367
Phone
+98 11 1220 7918
Fax
+98 11 1220 7918
Email
hagar2q@yahoo.ca; z.molana@mubabol.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Zahra Moulana
Position
Student
Other areas of specialty/work
Street address
Ganje Afrooze Ave,University Sq.
City
Babol
Postal code
4717641367
Phone
+98 11 1220 7918
Fax
+98 11 1220 7918
Email
z.molana@mubabol.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)