Population pharmacokinetics of rifampicin in staphylococcal osteoarticular infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study aims to develop a population pharmacokinetic model for oral rifampicin in adults undergoing medico-surgical treatment for staphylococcal OAIs, including prosthetic joint infections and osteomyelitis. The project also evaluates the pharmacokinetics of the partner antibiotic (levofloxacin or ciprofloxacin) and explores how exposure metrics relate to safety and tolerance. Blood samples are collected at multiple time points to characterize drug concentrations, with modeling performed using NONMEM to identify covariates that explain variability. A 12-month follow-up will assess relapse, tolerance, and microbiological outcomes. The study emphasizes pharmacokinetic understanding to optimize dosing in this patient population.

Why it matters

Who can join: the full rules

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

Where it's running

• Groupe hospitalier Diaconesses Croix Saint Simon
  Paris, Paris, France Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.