Doxycycline Plus Streptomycin Versus Ciprofloxacin Plus Rifampicin in Spinal Brucellosis
| ISRCTN | ISRCTN31053647 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31053647 |
| Secondary identifying numbers | 04/131 |
- Submission date
- 22/03/2006
- Registration date
- 29/03/2006
- Last edited
- 13/10/2009
- 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 Emine Alp
Scientific
Scientific
Department of Infectious Disease
Erciyes University Medical School
Kayseri
38039
Türkiye
| ealp@erciyes.edu.tr |
Study information
| Study design | An open, controlled and non-randomized trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Ciprofloxacin plus rifampicin may be an alternative treatment regimen to doxycycline plus streptomycin in the treatment of spinal brucellosis |
| Ethics approval(s) | Yes, Approved by the Ethical Committee of Erciyes University, approval date: 4/05/2001, reference number: 04/131 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Doxycycline, streptomycin, ciprofloxacin, rifampicin |
| Primary outcome measure | 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 study start date | 01/01/2002 |
| Completion date | 31/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 31 patients |
| Key inclusion criteria | The patients diagnosed with spinal brucellosis between January 2002 to December 2004 were enrolled into two study groups consecutively |
| Key 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) |
| Date of first enrolment | 01/01/2002 |
| Date of final enrolment | 31/12/2004 |
Locations
Countries of recruitment
- Türkiye
Study participating centre
Department of Infectious Disease
Kayseri
38039
Türkiye
38039
Türkiye
Sponsor information
Erciyes University Medical School (Turkey)
University/education
University/education
Department of Infectious Disease
Erciyes University Medical School
Kayseri
38039
Türkiye
| ealp@erciyes.edu.tr | |
"ROR" |
https://ror.org/047g8vk19 |
Funders
Funder type
University/education
The study was supported by Infectious Disease Clinic, Erciyes University Medical School (Turkey)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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? |
|---|---|---|---|---|---|
| Results article | results | 11/04/2006 | Yes | No |
