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

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)

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