comparison the effect of levofloxacin plus doxycyclin with doxycyclin plus rifampin in treatment and recurrence of brucellosis
Design
double blinded clinical trial
Settings and conduct
study will be done in infectious disease clinics on patients which brucellosis is diagnosed by lab data and clinical finding. drugs are allocated randomly in same boxes
Participants/Inclusion and exclusion criteria
inclusion criteria: age more than 18 years with brucellosis
exclusion criteria: pregnancy, age under 18 years, side effect, sensitivity to drugs
Intervention groups
case group receive levofloxacin 750 mg daily plus doxycycline 100 mg /BD and control group receive doxycycline 100 mg/BD plus 600 mg daily for 2 month.
Comparison of effect of levofloxacine +doxycycline with rifampin + doxycycline in treatment and relapse of brucellosis
Public title
Double blinded clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients older than 18 years with brucellosis
Exclusion criteria:
pregnancy
history of sensitivity to drug
meningitis
endocarditis
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
280
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization :randomization with using of table of randomized numbers. if number 0-4 appear case is allocated in group A and if 5-9 appear the case is allocated in group B.
Blinding (investigator's opinion)
Double blinded
Blinding description
Doctors and patient are unaware of kinds of drugs , the chief manager is aware if group and drug and the analyse is done with someone unaware of groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
دانشگاه علوم پزشکی سنندج
Secondary trial Id
IR.MUK.REC.1397.188
Registration date
2018-09-25, 1397/07/03
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of kurdistan university of medical science
Street address
pasdaran Ave
City
sanadaj
Province
Kurdistan
Postal code
6617978743
Approval date
2018-12-03, 1397/09/12
Ethics committee reference number
IR.MUK.REC.1397.188
Health conditions studied
1
Description of health condition studied
brucellosis disease
ICD-10 code
A23.0
ICD-10 code description
Brucellosis due to Brucella melitensis
Primary outcomes
1
Description
fever
Timepoint
1 MONTH, 2 MONTH, SIX MONTH AFTER TREATMENT
Method of measurement
by thermometer and patient report
2
Description
body pain
Timepoint
1 MONTH, 2 MONTH, SIX MONTH AFTER TREATMENT
Method of measurement
patient report
3
Description
DIAPHORESIS
Timepoint
1 MONTH, 2 MONTH, SIX MONTH AFTER TREATMENT
Method of measurement
patient report
4
Description
diaphoresis
Timepoint
1 MONTH, 2 MONTH, SIX MONTH AFTER TREATMENT
Method of measurement
patient report
5
Description
ESR
Timepoint
1 MONTH, 2 MONTH, SIX MONTH AFTER TREATMENT
Method of measurement
by laborator
6
Description
CRP
Timepoint
1 MONTH, 2 MONTH, SIX MONTH AFTER TREATMENT
Method of measurement
BY laboratoary
7
Description
WRIGHT
Timepoint
1 MONTH, 2 MONTH, SIX MONTH AFTER TREATMENT
Method of measurement
agglutination test
8
Description
2ME
Timepoint
1 MONTH, 2 MONTH, SIX MONTH AFTER TREATMENT
Method of measurement
agglutination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients with brucellosis who is diagnosed by clinical finding and lab data . patients with compatible sign and symptom ; if have a wright test equal or more than 1/160 is allocated in case group. This group receive levofloxacine 750 mg daily and doxycycline 100 mg twice daily . 1 and 2 month after treatment CBC, ESR,CRP , wright, coombs wright and 2ME will be checked. duration of therapy is 2 month . levofloxacine is produced by ABIDI company and doxycycline is produced by RAZAK company.
Category
Treatment - Drugs
2
Description
Control group: patients with brucellosis who is diagnosed by clinical finding and lab data . patients with compatible sign and symptom ; if have a wright test equal or more than 1/160 is allocated in case group and this group will be treated by doxtcycline and rifampine for 2 month. Dosage of doxycycline is 100 mg BD and rifampine 600 mg daily .drugs are produced by RAZEK company . after 1 and 2 mon after treatment clinical sign and symptom and sign will be evaluated and wright, coombs wright and 2ME will be assessed .
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Infectious disease clinic
Full name of responsible person
Behzad Mohsenpour
Street address
Pasdaran
City
Sanandaj
Province
Kurdistan
Postal code
6617978743
Phone
+98 87 3366 4958
Email
behzadmohsenpour@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
ebrahim ghaderi
Street address
kurdistan university of medical science, pasdaran Blvd,sanandaj, kurdistan, IRAN
City
Sanandaj
Province
Kurdistan
Postal code
6617978743
Phone
+98 87 3366 4958
Fax
+98 87 3366 4957
Email
behzadmohsenpour@yahoo.com
Web page address
http://www.muk.ac.ir/Muk.aspx
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
Behzad Mohsenpour
Position
Associate Prefessor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Pasdaran
City
Sanandaj
Province
Kurdistan
Postal code
6617978743
Phone
+98 87 3366 4958
Email
behzadmohsenpour@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Behzad Mohsenpour
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Pasdaran
City
Sanandaj
Province
Kurdistan
Postal code
6617978743
Phone
+98 87 3366 4958
Email
behzadmohsenpour@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Behzad Mohsenpour
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Pasdaran
City
Sanandaj
Province
Kurdistan
Postal code
6617978743
Phone
+98 87 3366 4958
Email
behzadmohsenpour@yahoo.com
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