Comparison the efficacy of gentamicin for 5 days plus doxycycline for 8 weeks versus streptomycin for 2 weeks plus doxycycline for 45 days in the tratment of human brucellosis
Streptomycin plus doxycycline and doxycycline plus rifampin are considered as two optimal regimens endorsed by the WHO for the treatment of brucellosis. Emergence of mycobacterial resistance to rifampin and XDR tuberculosis are reasons for selection of a regimen free of rifampin for the treatment of human brucellosis. Efficacy of gentamicin for 5 days plus doxycycline for 8 weeks was 100% in children with brucellosis. Since the efficacy of this regimen in adult cases of brucellosis has not been determined, the purpose of this study was to compare the efficacy of this regimen versus streptomycin for 2 weeks plus doxycycline for 45 days in the treatment of adult cases of human brucellosis.
From April 2005 to September 2008 patients with brucellosis who attended at the Department of Infectious Diseases of Babol Medical University, randomly received gentamicin 5 mg/kg/day at most 240 mg/day for 5 days plus doxycycline 100 mg twice daily for eight weeks (GD group) versus streptomycin 1gr IM for 2 weeks plus the same dose of doxycycline for 45 days (SD group).After treatment all cases were followed for one year. Our exclusion criteria were age of less than 14 years, spondylitis, neurobrucellosis, pregnancy and those received antibiotics more than 2 days. The sample size for each group was estimated 83 cases based on relapse and failure rate of 10% in the SD group and prediction of no relapse and failure of therapy with GD group. The primary outcome was clinical improvement without any adverse effects of drugs.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138708191441N1
Registration date:2008-12-07, 1387/09/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2008-12-07, 1387/09/17
Registrant information
Name
Mohammad Reza Hasanjani Roushan
Name of organization / entity
Yahyanejad Hospital,Babol Medical University
Country
Iran (Islamic Republic of)
Phone
+98 11 1222 3594
Email address
mr.roshan@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol Medical Research Center,Razi Medical Laboratory center
Expected recruitment start date
2005-04-01, 1384/01/12
Expected recruitment end date
2008-09-01, 1387/06/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the efficacy of gentamicin for 5 days plus doxycycline for 8 weeks versus streptomycin for 2 weeks plus doxycycline for 45 days in the tratment of human brucellosis
Public title
New regimen of therapy in the treatment of Brucellosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria;all uncomplicated adult patients with brucellosis (except peripheral arthritis,sacroiliitis,epididymoorchitis).Exclusion criteria: age of less than 14 years, spondylitis, neurobrucellosis, pregnancy and receiving antibiotics more than 2 days before enrollment.
Age
From 14 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
166
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Secondary trial Id
Registration date
2017-11-21, 1396/08/30
Ethics committees
1
Ethics committee
Name of ethics committee
The ethics committee of Babol Medical University
Street address
Gangafroz Avenue,Babol Medical University
City
Babol
Postal code
4717641367
Approval date
2005-05-14, 1384/02/24
Ethics committee reference number
1
Health conditions studied
1
Description of health condition studied
Brucellosis
ICD-10 code
ICD-10 A23
ICD-10 code description
Brucella mellitensis
Primary outcomes
1
Description
Cure
Timepoint
After completion of therapy
Method of measurement
Improvement of all clinical symptoms and signs
Secondary outcomes
1
Description
Failure of therapy
Timepoint
After completion of treatment
Method of measurement
Persistence of the clinical signs and symptoms of the disease after treatment
2
Description
Relapse
Timepoint
Every three months interval for 12 months after treatment
Method of measurement
Reapearance of the clinical symptoms and signs of brucellosis during follow up period with increasing of the titers of STA or 2ME or isolation of brucella from blood culture either in symptomatic or asymptomatic cases
3
Description
Adverse effects of the drugs
Timepoint
During the course of treatment
Method of measurement
Measurement of BUN, creatinin, audial complaints
Intervention groups
empty
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Infectious Diseases,Yahyanejad Hospital,Babol Medical University
Full name of responsible person
Mohammad Reza Hasanjani Roushan
Street address
Yahyanejad Hospital,Modares Avenue
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
Research Center of Babol Medical University,Gangafroz Avenue
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
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
2
Sponsor
Name of organization / entity
Razi Laboratory
Full name of responsible person
Mohammad Jafar Soleimani Amiri
Street address
Modares Avenue, Razi Laboratory
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Razi Laboratory
Proportion provided by this source
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
Yahyanejad Hospital, Babol Medical University
Full name of responsible person
Mohammad Reza Hasanjani Roushan
Position
Professor and head of the Department of Infectious Diseases
Other areas of specialty/work
Street address
Yahyanejad Hospital,Modares Avenue
City
Babol
Postal code
4717641367
Phone
+98 11 1222 3594
Fax
Email
mr.roshan@mubabol.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol Medical University
Full name of responsible person
Mohammad Reza Hasanjani Roushan
Position
Professor and head of the Department of Infectious Diseases
Other areas of specialty/work
Street address
Yahyanejad Hospital,Modares Avenue
City
Babol
Postal code
Phone
+98 11 1222 3594
Fax
Email
mr.roshan@mubabol.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol Medical University
Full name of responsible person
Mohammad Reza Hasanjani Roushan
Position
Professor and head of the Department of Infectious Diseases
Other areas of specialty/work
Street address
Yahyanejad Hospital, Modares Avenue
City
Babol
Postal code
4717641367
Phone
+98 11 1222 3594
Fax
+98 11 1222 7667
Email
mr.roshan@mubabol.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)