The objective of this randomized, double blind trial is to investigate the effect of corticosteroid in in-patients brucellosis cases of infectious ward of Zanjan Shahid Beheshti Hospital. In this study, 48 patients who meet the inclusion/exclusion criteria will be recruited and randomly assigned into intervention or control group. The patients in the intervention group will receive the standard regimen plus dexamethasone (4 mg three times daily for 5 days) and the control group will only receive the standard regimen. Clinical status of patient, hospital stay, duration of illness, pain score, and use of analgesic will be measured and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106296922N1
Registration date:2011-08-02, 1390/05/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-08-02, 1390/05/11
Registrant information
Name
Afsaneh Karami
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 1727 0801
Email address
rastin@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zanjan University of Medical Sciences
Expected recruitment start date
2009-02-01, 1387/11/13
Expected recruitment end date
2009-08-01, 1388/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of administration of corticosteroid in the treatment of brucellosis
Public title
Corticosteroid in brucellosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Documented brucellosis patients with the age 12 years and more
Exclusion criteria: history of addiction, corticosteroid use, Immunodeficiency
Age
From 12 years old to 83 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
47
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zanjan University of Medical Sciences Ethical Committee
Street address
Azadi St., Zanjan city
City
Zanjan
Postal code
Approval date
2008-03-20, 1387/01/01
Ethics committee reference number
1390415
Health conditions studied
1
Description of health condition studied
Brucellosis
ICD-10 code
A23.9
ICD-10 code description
Brucellosis, unspecified
Primary outcomes
1
Description
Duration of admission
Timepoint
total days of admission. every day
Method of measurement
Hospital patienst records
2
Description
Pain
Timepoint
daily
Method of measurement
patient's complaint and physical examinations
3
Description
Clinical status
Timepoint
daily
Method of measurement
physical examination
4
Description
Analgesic usage
Timepoint
daily
Method of measurement
Based on the medical orders and nursing records
Secondary outcomes
1
Description
patient's stability
Timepoint
daily
Method of measurement
physical examination
Intervention groups
1
Description
Control group: Doxycycline capsule, 100 mg BD for 2 months + Rifampin capsule 300 mg daily for 2 months
Category
Treatment - Drugs
2
Description
Intervention group: Doxycycline 100 mg BD for 2 months + Rifampin 600 mg for 2 months as well as Dexamethasone 4 mg, IV, TDS for 5 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital -Zanjan - Iran
Full name of responsible person
Street address
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Vice-chancellor for Research affairs
Street address
Vice-chancellor for Research affairs, Zanjan University of Medical Sciences, Azadi St. Zanjan
City
Zanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Afsaneh Karami
Position
Infectious and Tropical disease specialist
Other areas of specialty/work
Street address
Infectious ward, Vali asr Hospital, Zanjan
City
Zanjan
Postal code
Phone
+98 24 1727 0801
Fax
Email
dr.akarami@yahoo.com ; rastin@zums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Afsaneh Karami
Position
Infectious and Tropical disease specialist
Other areas of specialty/work
Street address
Infectious ward, Vali asr Hospital- Zanjan
City
Zanjan
Postal code
Phone
+98 24 1727 0801
Fax
Email
dr.akarami@yahoo.com ; rastin@zums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Afsaneh Karami
Position
Infectious and Tropical disease Specialist
Other areas of specialty/work
Street address
Infectious ward- vali asr Hospital - Zanjan - Iran
City
Zanjan
Postal code
Phone
+98 24 1727 0801
Fax
Email
dr.akarami@yahoo.com; rastin@zums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)