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About
The primary objective is: to assess the microbiological success of the combination of levofloxacin and rifampicin, administered for 32 to 37 days, as oral replacement therapy of an empirical antibiotic therapy of a maximum of 5 to 10 days given intravenously, in the treatment of OsteoArticular Prosthetic Infections (OAPI), with a two-stage revision of the prosthesis.
The secondary endpoints are:
Enrollment
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Inclusion criteria
Osteoarticular prosthetic bacterial infection (hip or knee)
Documented microbiological infection due to Staphylococcus aureus and/or coagulase-negative staphylococci, susceptible to fluoroquinolones and to rifampicin with:
Two-stage surgical management with: during the first operative stage: removal of the prosthesis, large debridement, implantation or not of a spacer during the second operative stage: implantation of a new cemented prosthesis or not (If possible, without antibiotics as recommended by Sofcot (25), otherwise containing gentamicin).
Negative urine pregnancy test for females of child-bearing age.
A barrier contraception method throughout the duration of treatment and for the 4 weeks following the discontinuation of rifampicin for females of child-bearing age.
Exclusion criteria
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Primary purpose
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10 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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