Infection Clinical Trial
Official title:
Pharmacological Comparison of Continuous and Intermittent Infusions of Cloxacillin During Bone and Joint Infections: a Prospective, Randomized, Open-label, Monocentric Crossover Study.
Our objective is to establish pharmacological equivalence of intermittent and continuous infusion of cloxacillin during methicillin-susceptible Staphylococcus aureus (MSSA) bone and joint infections (BJI). Twelve patients suffering MSSA BJI will receive both administration modalities and serum concentrations of cloxacillin will be determined after 3 days of II and 3 days of continuous infusion in a prospective, randomized, open-label, monocentric crossover study design.
Introduction Staphylococcus aureus is the main causative agent of bone and joint infections
(BJI). More than 80% of the strains isolated in France are methicillin-susceptible (MSSA).
During the early phase of MSSA BJI management national and international guidelines recommend
the use of intra-venous type M penicillin with a dosage ranging from 100 to 200 mg/kg/day.
Pharmacological properties of this class of penicillin require 4 to 6 infusions by day.
Continuous infusion of beta-lactams is increasingly used especially in intensive care units.
It allows an improvement of pharmacokinetic/pharmacodynamics (PK/PD) parameters and a
reduction in time dedicated to infusion preparations by the nurses. However pharmacological
data regarding such administration is required for type M penicillin.
Design A 6-day, prospective, randomized, open-label, monocentric crossover study
Participants Twelve adult patients with MSSA BJI
Intervention Patients will be randomized in two groups: the first group will receive 3 days
of cloxacillin (150 mg/kg/day) through 4 intermittent infusions/day followed by 3 days of
cloxacillin (150 mg/kg/day) through continuous infusion (2 infusions during 12 hours). In the
second group the infusion modalities will be inverted and continuous infusion will be
preceded by a loading dose. Serum concentrations of cloxacillin will be determined at Day 3
and Days 6 The area under the curve / minimal inhibitory concentration ratio will be use to
establish the equivalence between both administration modalities.
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