Contact information
Type
Scientific
Primary contact
Dr Emine Alp
ORCID ID
Contact details
Department of Infectious Disease
Erciyes University Medical School
Kayseri
38039
Turkey
ealp@erciyes.edu.tr
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
04/131
Study information
Scientific title
Acronym
Study hypothesis
Ciprofloxacin plus rifampicin may be an alternative treatment regimen to doxycycline plus streptomycin in the treatment of spinal brucellosis
Ethics approval
Yes, Approved by the Ethical Committee of Erciyes University, approval date: 4/05/2001, reference number: 04/131
Study design
An open, controlled and non-randomized trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Brucellosis is an infectious disease affecting multiple systems including vertebrae
Intervention
To compare the efficacy, adverse drug reactions, complications and cost of ciprofloxacin plus rifampicin versus doxycycline plus streptomycin in the treatment of spinal brucellosis
Intervention type
Drug
Phase
Not Specified
Drug names
Doxycycline, streptomycin, ciprofloxacin, rifampicin
Primary outcome measures
1. Clinical efficacy of ciprofloxacin plus rifampicin in spinal brucellosis
2. The prevalence of relapses
Secondary outcome measures
The cost of the two regimens
Overall trial start date
01/01/2002
Overall trial end date
31/12/2004
Reason abandoned
Eligibility
Participant inclusion criteria
The patients diagnosed with spinal brucellosis between January 2002 to December 2004 were enrolled into two study groups consecutively
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
31 patients
Participant exclusion criteria
1. Age less than 16 years
2. Pregnancy
3. Neurobrucellosis
4. Previous history of brucellosis and antimicrobial therapy and discontinuation of the therapy for any reason (allergy to any of the drugs, death, adverse reactions)
Recruitment start date
01/01/2002
Recruitment end date
31/12/2004
Locations
Countries of recruitment
Turkey
Trial participating centre
Department of Infectious Disease
Kayseri
38039
Turkey
Sponsor information
Organisation
Erciyes University Medical School (Turkey)
Sponsor details
Department of Infectious Disease
Erciyes University Medical School
Kayseri
38039
Turkey
ealp@erciyes.edu.tr
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
The study was supported by Infectious Disease Clinic, Erciyes University Medical School (Turkey)
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
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16606473
Publication citations
-
Results
Alp E, Koc RK, Durak AC, Yildiz O, Aygen B, Sumerkan B, Doganay M, Doxycycline plus streptomycin versus ciprofloxacin plus rifampicin in spinal brucellosis [ISRCTN31053647]., BMC Infect. Dis., 2006, 6, 72, doi: 10.1186/1471-2334-6-72.