Condition category
Infections and Infestations
Date applied
22/03/2006
Date assigned
29/03/2006
Last edited
13/10/2009
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 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

  1. 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.

Additional files

Editorial Notes