Prosthetic joint infection Infections and Infestations Prosthetic joint infection
Conditions
Interventions
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 an
Sponsors
University Hospital of Bellvitge (Hospital Universitario de Bellvitge) (Spain)
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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 patient?s 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Spain
Outcome results
None listed