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Population Pharmacokinetic Model of Rifampicin in Staphylococcal Osteoarticular Infections

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Groupe hospitalier Diaconesses Croix Saint Simon
RECRUITING
Paris
Time Frame
Start Date: 2023-06-10
Estimated Completion Date: 2029-06
Participants
Target number of participants: 40
Treatments
Experimental: All patients treated at the GHDCSS Reference Center for Complex Osteoarticular Infections for joint
Related Therapeutic Areas
Sponsors
Leads: Groupe Hospitalier Diaconesses Croix Saint-Simon

This content was sourced from clinicaltrials.gov