Comparative study of the efficacy of "short" and "long" duration levofloxacin-rifampicin combination therapy in the treatment of early postoperative and haemotogenous staphylococcal prosthetic joint infection
| ISRCTN | ISRCTN35285839 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35285839 |
| Secondary identifying numbers | LR-07 |
- Submission date
- 25/02/2011
- Registration date
- 04/08/2011
- Last edited
- 04/08/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Javier Ariza
Scientific
Scientific
Hospital Universitario de Bellvitge
Servicio de Enf. Infecciosas
c/ Feixa Llarga s/n
L'Hospitalet de Llobregat
Barcelona
08907
Spain
| jariza@bellvitgehospital.cat |
Study information
| Study design | Phase IV multicentre open trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Comparative study of the efficacy of "short" and "long" duration levofloxacin-rifampicin combination therapy in the treatment of early postoperative and haemotogenous staphylococcal prosthetic joint infection: a phase IV, multicentre, open trial |
| Study objectives | In the early postoperative and haematogenous staphylococcal prosthetic joint infection with stable implant, treated with surgical debridement and the antibiotic combination of rifampicin and levofloxacin, a short length of therapy of 8 weeks is non inferior to a longer standard therapy of 3 to 6 months (3 in hip prosthesis, and 6 in knee prosthesis) |
| Ethics approval(s) | Ethic Committee for Clinical Research (CEIC - Comité Ético de Investigación Clínica. Hospital Universitario de Bellvtige. c/ Feixa Llarga s/n. 08907 L'Hospitalet de Llobregat - Barcelona, Spain) approved on 6th November 2008 |
| Health condition(s) or problem(s) studied | Prosthetic joint infection |
| Intervention | In the same clinical setting of early postoperative or haematogenous staphylococcal prosthetic joint infection treated with surgical debridement. The intervention consists of administering the same antimicrobial therapy for different lengths of therapy: short duration of 8 weeks vs longer therapy of 3-6 months |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Levofloxacin, rifampicin |
| Primary outcome measure | To assess the efficacy of a treatment consisting in early surgical debridement and antimicrobial therapy with an oral combination of rifampin and levofloxacin during either 8 weeks (Short schedule group) or 3 (hip prosthesis) to 6 (knee prosthesis) months (Long schedule group; standard schedule), in the early-postoperative and haematogenous prosthesis joint infection of staphylococcal etiology (Staphylococcus aureus and Coagulase-negative Staphylococcus) |
| Secondary outcome measures | 1. Success of therapy: absence of fever, inflammatory signs or fistula and absence of radiographic prosthesis loosening during the follow-up (12 months) 2. Failure, defined as: 2.1. Persistence of the infection either during treatment (persistence of inflammatory symptoms and signs which lead to the removal of the prosthesis) or at the end of treatment [(symptoms and signs suggestive of infection, with positive cultures (either from surgical or clinically significant samples]). A high value of C-reactive protein at the end of treatment, without clinical signs of relapse or persistence, is not considered criteria of failure by itself. 2.2. Relapse of the infection: initial remission of inflammatory symptoms and signs with posterior reappearance and positive cultures of the same microorganism responsible of the infection from surgical or clinically significant samples. 2.3. Reinfection: initial remission of inflammatory symptoms and signs with posterior reappearance and positive cultures of a different microorganism from surgical or clinically significant samples. In cases of persistence or relapse, evaluation of possible development of resistance to either rifampicin or quinolones will be performed. 3. Aseptic prosthesis loosening during follow-up, with no clinical evidence of infection and negative cultures 4. Adverse events. All adverse events will be collected, and the possible relation with the antibiotics will be evaluated. Serious adverse events will be reported to authorities, according to the law (Real Decreto 223/2004). Especial attention will be given to the following adverse events: 4.1. Gastrointestinal adverse events: vomiting, nausea, etc 4.2. Rise in liver enzymes 4.3. Flu-like syndrome secondary to rifampicin (head-ache, chills or rigors, arthralgias, myalgias ) 4.4. Lupus-like syndrome secondary to rifampicin 4.5. Myopathy or tendinitis secondary to levofloxacin |
| Overall study start date | 13/04/2009 |
| Completion date | 13/04/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 195 |
| Key inclusion criteria | 1. Diagnosis of prosthesis joint infection: fever, local pain, inflammatory signs or purulent exudate in the surgical wound and/or purulent macroscopic exudate during the debridement surgery. Prosthesis joint infection will be considered early-postoperative if symptoms and signs begin in the first 30 days after the placement of the prosthesis. It will be considered haematogenous when the clinical picture is acute and/or it develops in the setting of bacteremia or concomitant to other distant infection. 2. Diagnosis of staphylococcal etiology: Staphylococcus sp must be isolated from reliable samples, such as blood cultures or purulent exudate obtained during surgery or by arthrocentesis. Polymicrobial cases will be accepted if it is not necessary to add more antibiotics with anti-staphylococcal activity to the oral combination of rifampicin and levofloxacin. |
| Key exclusion criteria | 1. Age less than 18 years 2. Pregnancy or breastfeeding 3. Women who may become pregnant in whom methods of contraception cannot be guaranteed during the period of antibiotic therapy 4. Life-expectancy less than 6 months 5. Unwillingness to parcipate in the study or to give written-informed consent 6. Unwillingness to avoid the use of contact lenses during the period of antibiotic therapy 7. Reasonable doubts about the patients treatment observance 8. Allergy or intolerance to quinolones and/or rifampicin which lead to the antimicrobial(s) withdrawal. Prosthesis joint infection by quinolones and/or rifampicin resistance 9. Administration of antibiotics with anti-staphylococcal activity different from rifampicin or levofloxacin for more than 7 days, during the period of study or during the follow-up 10. Delay in performing the surgical debridement of the prosthesis infection of 21 or more days, counting from the beginning of symptoms and signs of infection 11. Radiographic signs of prosthesis loosening in simple X-ray 12. Prosthesis removal during surgery |
| Date of first enrolment | 13/04/2009 |
| Date of final enrolment | 13/04/2013 |
Locations
Countries of recruitment
- Spain
Study participating centre
Hospital Universitario de Bellvitge
Barcelona
08907
Spain
08907
Spain
Sponsor information
University Hospital of Bellvitge (Hospital Universitario de Bellvitge) (Spain)
Hospital/treatment centre
Hospital/treatment centre
Hospital Universitario de Bellvitge
c/o Dr. Javier Ariza
Servicio de Enf. Infecciosas
c/ Feixa Llarga s/n
L'Hospitalet de Llobregat
Barcelona
08907
Spain
| jariza@bellvitgehospital.cat | |
"ROR" |
https://ror.org/00epner96 |
Funders
Funder type
Government
Carlos III Health Institute (Instituto de Salud Carlos III) (Spain) - Health Research Fund (Fondo de Investigaciones Sanitarias [FIS]) - Ministry of Health ref: Expte EC/08/00113
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 |
