Treatment of Methicillin-sensitive Staphylococcus Aureus (MSSA)
Status:
Completed
Trial end date:
2011-10-01
Target enrollment:
Participant gender:
Summary
Background:
One of the leading causes of peri-operative osteoarticular infections (OAI) is Staphylococcus
aureus. Treatment usually requires surgical debridement in association with appropriate
antibiotic therapy. After surgery, an intravenous (IV) antibiotic therapy is routinely
indicated for 10 to 15 days, followed by a minimal one-month oral treatment. In this
protocol, the latter includes clindamycin in combination with rifampin or levofloxacin.
Clindamycin is considered a good option in staphylococcal infections, because of its action
against biofilm formation and bacterial adherence, its high level of joint and bone
penetration and its good tolerance. Rifampin, a potent cytochrome P-450 inducer, enhances the
elimination of a large number of drugs. Therefore, an influence of rifampin on clindamycin
pharmacokinetics must be considered.
Objectives:
The primary objective is to compare the influence of rifampin and levofloxacin respectively
on the pharmacokinetics of clindamycin in a randomized series of peri-operative
staphylococcal OAI. The investigators then seek to determine the optimal drug association
with regard to infection control and drug tolerance.
Study design:
Monocentric, randomized, open label, comparative study
Study period:
From November 2010 to October 2011.
Materials and Methods:
Following surgical debridement and after 10 to 15 days of IV antibiotherapy, patients are
randomly assigned either to the "clindamycin/rifampin" arm either to the
"clindamycin/levofloxacin" arm, according to the antimicrobial susceptibility testing. Peak
and trough serum concentrations of clindamycin are measured at day-1, day-15 and day-30 of
oral treatment. Rifampin and levofloxacin serum concentrations are measured at the same
intervals to monitor patient compliance.