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Population Pharmacokinetic Model of Rifampicin in Staphylococcal Osteoarticular Infections

NCT07788404 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-08-26

No results posted yet for this study

Summary

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).

Conditions

  • Prosthetic Joint Infection
  • Osteomyelitis
  • Staphylococcal Infections

Interventions

DRUG

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

This study primarily aims to evaluate the pharmacokinetics of rifampicin, but also of one of the two partner antibiotics, levofloxacin or ciprofloxacin, used in the treatment of staphylococcal osteoarticular infections, whether or not they are present in the body. To this end, 12 blood samples, totaling 60 ml per patient, will be required. These samples will be collected specifically for this clinical research. The remainder of the study will be conducted as part of standard patient care.

Sponsors & Collaborators

  • Groupe Hospitalier Diaconesses Croix Saint-Simon

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-10
Primary Completion
2028-06-30
Completion
2029-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07788404 on ClinicalTrials.gov