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Population Pharmacokinetic Model of Rifampicin in Staphylococcal Osteoarticular Infections

RecruitingNAAges 18 Years - anyAllGroupe Hospitalier Diaconesses Croix Saint-Simon
NCT07788404 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 a

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patient informed about the study and signed written consent obtained * Male or female participant aged 18 years or older * Staphylococcal osteoarticular infection (prosthetic joint infection of hip, knee, or shoulder; chronic osteomyelitis; or native joint infection) susceptible to rifampicin and levofloxacin or ciprofloxacin * Indication for combined medico-surgical treatment of the osteoarticular infection Exclusion Criteria: * Septic shock requiring vasopressor support * Prior rifampicin treatment within 1 month preceding inclusion * Contraindication to rifampicin (known allergy, major drug interaction, or hepatic cirrhosis) * End-stage renal disease on chronic dialysis * Pregnant or breastfeeding woman * Adult patient unable or unfit to give informed consent * Subject deprived of liberty by judicial or administrative decision * Subject not affiliated with or beneficiary of a national social security scheme
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What it tests

  • This study focuses on the pharmacokinetics of rifampicin and levofloxacin or ciprofloxacin, which are used in the treatment of osteoarticular infections caused by susceptible staphylococci as part of
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Where

1 site
Groupe hospitalier Diaconesses Croix Saint Simon
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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