Ofloxacin plus rifampicin versus doxycycline plus rifampicin in the treatment of brucellosis: a randomised clinical trial
ISRCTN | ISRCTN11871179 |
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DOI | https://doi.org/10.1186/ISRCTN11871179 |
Secondary identifying numbers | N/A |
- Submission date
- 04/06/2004
- Registration date
- 08/06/2004
- Last edited
- 10/08/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Oguz Karabay
Scientific
Scientific
Izzet Baysal Faculty of Medicine
Infectious Diseases and Clinical Microbiology
Bolu
14280
Türkiye
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study objectives | The aim of the present study was to investigate the efficacy, adverse effect and cost of ofloxacin plus rifampicin therapy, and doxycycline plus rifampicin therapy and evaluate in the treatment of brucellosis. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Brucellosis |
Intervention | This study was carried out in the Social Security Duzce Hospital and Abant Izzet Baysal Universty Duzce Medical School in Turkey. After obtaining informed consent, a detailed medical history was taken from each patient and a complete physical examination was performed. Patients who met the criteria for entry were randomly assigned to receive in a 1:1 ratio doxycycline plus rifampicin or ofloxacin plus rifampicin: 1. The doxycycline plus rifampicin group had 14 patients who received doxycycline 100 mg twice daily and rifampicin 600 mg once daily for 45 days 2. The ofloxacin plus rifampicin group had 15 patients who received ofloxacin 400 mg once daily and rifampicin 600 mg once daily for 30 days Patients were hospitalised for at least 10 days at the beginning of treatment in order to monitor clinical response and potential side effects. The patients were assessed and laboratory tests were also performed during the therapy period in the 2nd, 4th, and 6th week of therapy. At the end of therapy, laboratory tests were reassessed at months 1, 2 and 3, as well as whenever clinical symptoms reappeared. |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Ofloxacin, rifampicin, doxycycline |
Primary outcome measure | Not provided at time of registration |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/12/1999 |
Completion date | 01/12/2001 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Not Specified |
Target number of participants | 29 |
Key inclusion criteria | Patients suspected to have brucella infection on the basis of clinical (fever, limb and back pains, sweating, fatigue, hepatomegaly, splenomegaly, arthritis, sacroileitis, spondylitis, orchitis and headache) and laboratory findings were hospitalised. The diagnosis was based on the presence of signs and symptoms compatible with brucellosis including a positive agglutination titre (greater than or equal to 1/160) and/or a positive culture. All sera obtained from the patients were examined by serial dilution (from 1:10 to 1:1280) using bacterial antigen. |
Key exclusion criteria | Not provided at time of registration |
Date of first enrolment | 01/12/1999 |
Date of final enrolment | 01/12/2001 |
Locations
Countries of recruitment
- Türkiye
Study participating centre
Izzet Baysal Faculty of Medicine
Bolu
14280
Türkiye
14280
Türkiye
Sponsor information
Izzet Baysal Faculty of Medicine (Turkey)
Hospital/treatment centre
Hospital/treatment centre
c/o Dr Oguz Karabay
Infectious Diseases and Clinical Microbiolgy
Bolu
14280
Türkiye
Phone | +90 374 253 4656 / 4140 |
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drkarabay@yahoo.com | |
https://ror.org/01x1kqx83 |
Funders
Funder type
Not defined
Not provided at time of registration
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | Results | 23/06/2004 | Yes | No |