Ofloxacin plus rifampicin versus doxycycline plus rifampicin in the treatment of brucellosis: a randomised clinical trial

ISRCTN ISRCTN11871179
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

Izzet Baysal Faculty of Medicine
Infectious Diseases and Clinical Microbiology
Bolu
14280
Türkiye

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesThe 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) studiedBrucellosis
InterventionThis 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Ofloxacin, rifampicin, doxycycline
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/12/1999
Completion date01/12/2001

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants29
Key inclusion criteriaPatients 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 criteriaNot provided at time of registration
Date of first enrolment01/12/1999
Date of final enrolment01/12/2001

Locations

Countries of recruitment

  • Türkiye

Study participating centre

Izzet Baysal Faculty of Medicine
Bolu
14280
Türkiye

Sponsor information

Izzet Baysal Faculty of Medicine (Turkey)
Hospital/treatment centre

c/o Dr Oguz Karabay
Infectious Diseases and Clinical Microbiolgy
Bolu
14280
Türkiye

Phone +90 374 253 4656 / 4140
Email drkarabay@yahoo.com
ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 23/06/2004 Yes No