Condition category
Infections and Infestations
Date applied
04/06/2004
Date assigned
08/06/2004
Last edited
10/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Oguz Karabay

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Ofloxacin, rifampicin, doxycycline

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/12/1999

Overall trial end date

01/12/2001

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

29

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/12/1999

Recruitment end date

01/12/2001

Locations

Countries of recruitment

Turkey

Trial participating centre

Izzet Baysal Faculty of Medicine
Bolu
14280
Turkey

Sponsor information

Organisation

Izzet Baysal Faculty of Medicine (Turkey)

Sponsor details

c/o Dr Oguz Karabay
Infectious Diseases and Clinical Microbiolgy
Bolu
14280
Turkey
+90 374 253 4656 / 4140
drkarabay@yahoo.com

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Not defined

Funder name

Not provided at time of registration

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in: http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=15214959

Publication citations

  1. Results

    Karabay O, Sencan I, Kayas D, Sahin I, Ofloxacin plus rifampicin versus doxycycline plus rifampicin in the treatment of brucellosis: a randomized clinical trial [ISRCTN11871179]., BMC Infect. Dis., 2004, 4, 18, doi: 10.1186/1471-2334-4-18.

Additional files

Editorial Notes