Comparative study of response to treatment and recurrence of brucellosis in the 4 and 6 week treatment groups with doxycycline, streptomycin and hydroxychloroquine. A single blinded randomised clinical trial.
Comparative study of response to treatment and recurrence of brucellosis in the 4 and 6 week treatment groups with doxycycline, streptomycin and hydroxychloroquine. A single blinded randomised clinical trial.
Design
two arm parallel group randomized trial with blinded postoperative care and outcome assessment.
Each group has 51 people and a total of 102 people
Settings and conduct
Farshchian Hospital, Mirzadeh Eshghi Ave.Hamadan
single blinded randomised clinical trial
Patients assigned to drug regimens do not know
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1-patients with sign and symptoms of brucellosis have Wright test of more than 1/160 and 2ME titer more than 1/80
2-age of 18 years or older
3-Consent to participate in the study
Exclusion criteria:
Chronic Illnesses
Any serious complication of brucellosis
Intervention groups
A comparative study of response to treatment and recurrence of brucellosis in two group.
In the intervention group, the patient is treated with the standard Doxycycline-Streptomycin (4-week Doxycycline, 3-week Streptomycin) plus hydroxy-chloroquine 400 mg daily for 4 weeks.
In the control group, the patient is treated with the standard Doxycycline-Streptomycin (6-week Doxycycline, 3-week Streptomycin) and Hydroxychloroquine 400 mg daily for 6 weeks..
Main outcome variables
response to treatment, recurrence, side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160523028008N4
Registration date:2019-07-02, 1398/04/11
Registration timing:retrospective
Last update:2019-07-02, 1398/04/11
Update count:0
Registration date
2019-07-02, 1398/04/11
Registrant information
Name
Mohammad Faryadras
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3428 9706
Email address
m.faryadras@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of response to treatment and recurrence of brucellosis in the 4 and 6 week treatment groups with doxycycline, streptomycin and hydroxychloroquine. A single blinded randomised clinical trial.
Public title
Comparative study of response to treatment and recurrence of brucellosis in the 4 and 6 week treatment groups with doxycycline, streptomycin and hydroxychloroquine.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with sign and symptoms of brucellosis have Wright test of more than 1/160 and 2ME titer more than 1/80
Age of 18 years or older
Consent to participate in the study
Exclusion criteria:
being pregnant
Chronic Illnesses
Any serious complication of brucellosis
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding: The patients will not aware of the type of treatment they will receive but the physician who will examine the patents will be aware of the type of treatment. Therefore, the trial will be run as single-blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2019-04-27, 1398/02/07
Ethics committee reference number
IR.UMSHA.REC.1398.022
Health conditions studied
1
Description of health condition studied
Brucellosis
ICD-10 code
A23
ICD-10 code description
Brucellosis
Primary outcomes
1
Description
response to treatment
Timepoint
at 1, 4, and 6 months after treatment
Method of measurement
through history taking and physical examination
2
Description
recurrence
Timepoint
4 and 6 months after treatmen
Method of measurement
Recurrence of the patient's clinical symptoms
Secondary outcomes
1
Description
Incidence of probable adverse effects such as hepatitis and visual impairment
Timepoint
at 1, 4, and 6 months after treatment
Method of measurement
through history taking and physical examination
Intervention groups
1
Description
Intervention group: Doxycycline - Streptomycin (4 weeks doxycycline, 3 weeks streptomycin) plus hydroxy chloroquine 400 mg daily for 4 weeks
Category
Treatment - Drugs
2
Description
Control group: Doxycycline - Streptomycin (6 week Doxycycline, 3 weeks Streptomycin) and Hydroxychloroquine 400 mg daily for 6 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Dr Mohammad Mahdi Majzoobi
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave
City
Hamdan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
mahdi.majzoobi@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
s-bashirian@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Mohammad Mahdi Majzoobi
Position
Specialist in Infectious Diseases
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave
City
Hamadn
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
mahdi.majzoobi@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Mohammad Mahdi Majzoobi
Position
Specialist in Infectious Diseases
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave
City
Hamadn
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
mahdi.majzoobi@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Farshchian Hospital
Position
Specialist in Infectious Diseases
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
mahdi.majzoobi@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD