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The effect of hydroxychloroquine versus standard drug therapy on the treatment and recurrence of brucellosis: a single blinded randomized clinical trial

Protocol summary

Summary
Objectives: To assess the effect of hydroxychloroquine versus standard drug therapy on the treatment and recurrence of brucellosis Design: A single blinded randomized clinical trial. Setting and conduct: All eligible patients with acute or chronic brucellosis who will refer to clinic of Farshchian Hospital during the study period will be enrolled in to the trial. Inclusion criteria: (a) patients with sign and symptoms of brucellosis have Wright test of more than 1/160 and 2ME titer more than 1/80; (b) patients with chronic brucellosis who did not responded to standard drug therapy with constant or increased 2ME titer; (c) age of 18 years or older. Exclusion criteria: (a) being pregnant; (b) having history of porphyria, psoriasis, degenerative macula, hemolytic diseases, gastrointestinal diseases, neurologic diseases, and G6PD deficiency. Intervention: oral hydroxychloroquine 400 mg daily for two months plus standard drug therapy for brucellosis. Control: only standard drug therapy for brucellosis. Primary outcome: response to treatment based on 2ME titer before treatment and 1, 2, 3, and 5 months later. Secondary outcome: Incidence of probable adverse effects such as hepatitis and visual impairment through history taking and physical examination at 1, 2, 3, and 5 months after treatment.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201406299014N37
Registration date: 2014-07-04, 1393/04/13
Registration timing: na

Last update:
Update count: 0
Registration date
2014-07-04, 1393/04/13
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Not enough for processing
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2014-07-23, 1393/05/01
Expected recruitment end date
2014-07-22, 1393/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of hydroxychloroquine versus standard drug therapy on the treatment and recurrence of brucellosis: a single blinded randomized clinical trial
Public title
The effect of hydroxychloroquine versus standard drug therapy on the treatment and recurrence of brucellosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a) patients with sign and symptoms of brucellosis have Wright test of more than 1/160 and 2ME titer more than 1/80; (b) patients with chronic brucellosis who did not responded to standard drug therapy with constant or increased 2ME titer; (c) age of 18 years or older. Exclusion criteria: (a) being pregnant; (b) having history of porphyria, psoriasis, degenerative macula, hemolytic diseases, gastrointestinal diseases, neurologic diseases, and G6PD deficiency.
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 176
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: Using balance block randomization with group f four so that every four patents will be randomly assigned to intervention and control groups. This process will be continued until to reach the sample size. 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.

Secondary Ids

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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
Postal code
6517838695
Approval date
2014-05-17, 1393/02/27
Ethics committee reference number
D/P/16/35/9/708

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
before treatment and 1, 2, 3, and 5 months later
Method of measurement
based on 2ME titer

Secondary outcomes

1

Description
Incidence of probable adverse effects such as hepatitis and visual impairment
Timepoint
at 1, 2, 3, and 5 months after treatment
Method of measurement
through history taking and physical examination

Intervention groups

1

Description
oral hydroxychloroquine 400 mg daily for two months plus standard drug therapy for brucellosis
Category
Treatment - Drugs

2

Description
only standard drug therapy for brucellosis
Category
Other

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
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research the Technology, Hamadan 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
Farshchian Hospital
Full name of responsible person
Dr Mohammad Mahdi Majzoobi
Position
Specialist in Infectious Diseases
Other areas of specialty/work
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0717
Fax
Email
mahdi.majzoobi@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Farshchian Hospital
Full name of responsible person
Dr Mohammad Mahdi Majzoobi
Position
Specialist in Infectious Diseases
Other areas of specialty/work
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0717
Fax
Email
mahdi.majzoobi@umsha.ac.ir
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
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Statistical Analysis Plan
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Informed Consent Form
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Clinical Study Report
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Analytic Code
empty
Data Dictionary
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