Comparison of the efficacy of three drug regimens Doxycycline – Rifampin – Gentamicin, Doxycycline – Rifampin– Ciprofloxacin and Doxycycline – Co-trimoxazole – Gentamicin on relapse of disease in patients with complicated brucellosis: A clinical trial
The aim of this study: Comparison of the efficacy of Doxycycline – Rifampin – Gentamicin, Doxycycline – Rifampin– Ciprofloxacin and Doxycycline – Co-trimoxazole – Gentamicin in patients with complicated brucellosis. Study design: After explaining the purpose of the study and obtaining the informed consent, patients will be randomly allocated into A, B and C groups. Randomization will be performed using random block sizes of 3. The study is randomized, single-center, phase 3 trial. Inclusion criteria: Brucella endocarditis; Neurobrucellosis; OCP consumption; Phenytoin consumption; Brucellosis relapse. Exclusion criteria: Stevens–Johnson Syndrom; Anaphylaxis; Pancreatitis; Pseudomembranous colitis; Renal failure. Sample size: 75 patients are participated in the study with 25 patients in each group. The intervention used in the study: Doxycycline 100 mg PO BID, Rifampicin 600 mg IV daily and PO after discharge, Gentamicin 80 mg IV TDS and Streptomycin 1 gr IM after discharge, Ciprofloxacin 400 mg IV and 500 mg PO BID after discharge and Co-trimoxazole (trimethoprim 80 mg/5ml and sulfamethoxazole 400 mg/5 ml) IV BID and PO after discharge. all regimen will be used for 6 months. Primary outcomes: Relapse
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017052734154N1
Registration date:2017-06-30, 1396/04/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-30, 1396/04/09
Registrant information
Name
Razieh Kazemi
Name of organization / entity
Islamic Azad University of Shahrood
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 6714
Email address
r.kazemi@iau-shahrood.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research and technology, Islamic Azad University of Shahrood
Expected recruitment start date
2017-06-22, 1396/04/01
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
Comparison of the efficacy of three drug regimens Doxycycline – Rifampin – Gentamicin, Doxycycline – Rifampin– Ciprofloxacin and Doxycycline – Co-trimoxazole – Gentamicin on relapse of disease in patients with complicated brucellosis: A clinical trial
Public title
The efficacy of Doxycycline – Rifampin – Gentamicin, Doxycycline – Rifampin– Ciprofloxacin and Doxycycline – Co-trimoxazole – Gentamicin in complicated brucellosis
Ethics Committee of Islamic Azad University of Shahrood
Street address
Islamic Azad University of Shahrood, Tehran Blvd, Shahrood
City
Shahroud
Postal code
3613773955
Approval date
2016-11-05, 1395/08/15
Ethics committee reference number
IR.IAU.SHAHROOD.REC.1395.1
Health conditions studied
1
Description of health condition studied
Brucellosis
ICD-10 code
A23
ICD-10 code description
Brucellosis
Primary outcomes
1
Description
Relaps
Timepoint
6 months
Method of measurement
Physical examination and Wright>or =1/40 and 2-ME>or=1/80
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Doxycycline 100 mg PO BID and Rifampicin 600 mg IV daily and PO after discharge and Gentamicin 80 mg IV TDS and Streptomycin 1 gr IM after discharge. This regimen prescribed for 6 months.
Category
Treatment - Drugs
2
Description
Intervention group: Doxycycline 100 mg PO BID and Rifampicin 600 mg IV daily and PO after discharge and Ciprofloxacin 400 mg IV and 500 mg PO BID after discharge. This regimen prescribed for 6 months.
Category
Treatment - Drugs
3
Description
Intervention group: Doxycycline 100 mg PO BID and Co-trimoxazole (trimethoprim 80 mg/5ml and sulfamethoxazole 400 mg/5 ml IV BID and PO after discharge and Gentamicin 80 mg IV TDS and Streptomycin 1 gr IM after discharge. This regimen prescribed for 6 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein hospital
Full name of responsible person
Raziyeh Kazemi
Street address
Imam Hossein Hospital, End of Ayatollah Towhidi avenue, Shahroud
City
Shahroud
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research and Technology, Islamic Azad University of Shahrood
Full name of responsible person
Sahebali Manafi
Street address
Islamic Azad University of Shahroud, Tehran Blvd
City
Shahroud
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 and Technology, Islamic Azad University of Shahrood
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
Islamic Azad University of Shahrood
Full name of responsible person
Raziyeh Kazemi
Position
Medical Student
Other areas of specialty/work
Street address
Islamic Azad University of Shahroud, Tehran Blvd, Shahrood
City
Shahroud
Postal code
Phone
+98 23 3239 1796
Fax
Email
kazemi.raziyeh95@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Ehsan Nezakati
Position
Infectious disease specialist
Other areas of specialty/work
Street address
Imam Hossein Hospital, End of Ayatollah Towhidi avenue
City
Shahroud
Postal code
Phone
+98 23 3239 1796
Fax
Email
nezakati@shmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University of Shahroud
Full name of responsible person
Raziyeh Kazemi
Position
Medical student
Other areas of specialty/work
Street address
Islamic Azad University of Shahrood, Tehran Blvd, Shahrood
City
Shahroud
Postal code
3613773955
Phone
+98 23 3239 1796
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)