Levamisole is modulator of immune response. T-reg cell has important role in inhibition of immune response during the infection. So presence of these cells in infection is a sign of progress to chronic disease. This research seeks to find a relationship between the uses of Levamisole with Gentamicin and Doxycycline and presence of T-reg. Therefore People with brucellosis are employed. After providing adequate information eligible volunteered patients will be enrolled in the study. Inclusion criteria: the patient had not received treatment, and also clinical signs and para clinical signs including, blood cultures, Wright test, 2ME and combs wright. Exclusion criteria: pregnant women; children younger than 8 years old; endocarditis, meningitis and spondylitis patients. Blood sampling is taken before treatment from responders to evaluate T-regulatory with flow cytometric technique. Patients are randomly divided into two 30 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 levamisole 80 mg for 6 weeks. All of examinations will be repeated and compared after 6 weeks and 6 months at the end of treatment, respectively. All in all, the quantitative existence of T-reg will be analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014042617430N1
Registration date:2014-05-12, 1393/02/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-05-12, 1393/02/22
Registrant information
Name
Soheil Ebrahimpour
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1220 7918
Email address
s.ebrahimpour@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
Pre and post treatment level of Regulatory T cells in Brucellosis patients received Gentamicin and Doxycycline with levamisole
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: the patient had not received treatment, and also clinical signs and para clinical signs including, blood cultures, Wright test, 2ME and combs wright.
Exclusion criteria: pregnant women; children younger than 8 years old; endocarditis, meningitis and spondylitis patients.
Age
From 8 years old to 139 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Ganj Afrooze Ave, University Sq .
City
Babol
Postal code
4717641367
Approval date
2014-04-23, 1393/02/03
Ethics committee reference number
304018/10/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
Quantity of regulatory T cells
Timepoint
Before treatment,6 weeks after begining of treatment,6months after end of treatment
Method of measurement
Flow cytometric
2
Description
Brucella bacteria
Timepoint
Before treatment,6 weeks after begining of treatment,6months after end of treatment
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
Control group :Adminisration Gentamicin 4-5 mg / kg (IM) for a week, Doxcycycline 100 mg/bid (oral) for 45 days
Category
Treatment - Drugs
2
Description
Intervention group: Adminisration Gentamicin 4-5 mg / kg (IM) for a week, Doxcycycline 100 mg/bid ( oral) for 45 days and levamisole 80 mg( oral )daily for 6 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol Ayatollah Rohani Hospital
Full name of responsible person
Soheil Ebrahimpour
Street address
University Sq Ave,Ganje Afrooze
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Ali Bijani
Street address
Ganje Afrooze Ave,University Sq
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
Mohammad Reza Hasanjani 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
Email
hagar2q@yahoo.ca drsoheil1503@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mohammad Reza Hasanjani 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
Email
hagar2q@yahoo.ca drsoheil1503@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Soheil Ebrahimpour
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
Email
drsoheil1503@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)