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Population Pharmacokinetic Model of Rifampicin in Staphylococcal Osteoarticular Infections

Study acronym: Ciné-RIF
StatusRecruiting
PhaseNot applicable
Started
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Record History

  1. Minor Study First Submitted
Staphylococcal osteoarticular infections (OAIs), including prosthetic joint infections and chronic osteomyelitis, represent a major cause of morbidity. Rifampicin is a key bactericidal antibiotic effective against staphylococcal biofilm. However, its pharmacokinetics exhibit substantial inter-individual variability due to complex hepatic metabolism and drug interactions. Currently, no prospective population pharmacokinetic (PopPK) model of rifampicin combined with levofloxacin or ciprofloxacin exists in patients with OAIs. Objectives: The primary objective of this study is to develop a population pharmacokinetic model of oral rifampicin in patients undergoing medico-surgical treatment for staphylococcal osteoarticular infections. Secondary objectives include evaluating the pharmacokinetics of the partner antibiotic (levofloxacin or ciprofloxacin), investigating the correlation between antibiotic exposure metrics (AUC, Cmax, AUC/MIC) and clinical/biological tolerance, and assessing 1-year infection relapse-free survival and resistance emergence. Study Design: Prospective, single-center, interventional study with minimal risks and constraints (RIPH 2) involving 40 participants recruited at the Reference Center for Complex Osteoarticular Infections (CRIOAC).
Trial Details
NCT Number NCT07788404
Lead Sponsor Groupe Hospitalier Diaconesses Croix Saint-Simon
Conditions
(from sponsor)
Prosthetic Joint Infection, Osteomyelitis, Staphylococcal Infections
Related terms Osteomyelitis, Staphylococcal Infections
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov