Prosthetic Joint InfectionCiné-RIFNCT07788404
Population Pharmacokinetic Model of Rifampicin in Staphylococcal Osteoarticular Infections
A study testing 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 in people with Prosthetic Joint Infection and Osteomyelitis, run by Groupe Hospitalier Diaconesses Croix Saint-Simon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prosthetic Joint Infection, Osteomyelitis, Staphylococcal Infections
- What is being tested?
- 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jun 2023to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Groupe hospitalier Diaconesses Croix Saint Simon
Paris, Paris, 75020
Younes KERROUMI, Clinical Research Physician, 0033144643384, ykerroumi@hopital-dcss.org
Valerie ZELLER, Infectious disease specialist
About this study
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).
Read the detailed description
Study Workflow and Pharmacokinetic Sampling Protocol:
Screening and Baseline: Adult patients hospitalized for staphylococcal prosthetic joint infection, chronic osteomyelitis, or native joint infection sensitive to rifampicin and levofloxacin/ciprofloxacin are screened. Clinical, demographic (age, sex, actual and ideal body weight), and biological data (renal function, liver function, serum albumin) are collected.
Pharmacokinetic Blood Sampling (12 samples total, 60 mL total volume): Day 2 / Day 3: 5 blood samples (5 mL each) collected pre-dose (t0, fasting) and at 1h, 2h, 4h, and 8h post-dose of rifampicin. Day 8 / Day 10: 5 blood samples (5 mL each) collected pre-dose (t0, fasting) and at 1h, 2h, 4h, and 8h post-dose of rifampicin and partner antibiotic (levofloxacin or ciprofloxacin). Day 28 / Day 32 (1-month follow-up visit): 2 blood samples (5 mL each) collected pre-dose and 2 hours post-dose during outpatient consultation.
Pharmacokinetic and Statistical Modeling: Population PK parameters (CL/F, V/F, ka) and inter-individual variability will be estimated using non-linear mixed-effects modeling (NONMEM v7.5). Influence of covariates (age, sex, weight, renal function, serum albumin) will be evaluated. One-Year Follow-up: Clinical follow-up at 12 months post-treatment initiation to evaluate infection relapse, tolerance, and microbiological
- Being tested
- 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
- Keywords
- Rifampicin, Levofloxacin, Ciprofloxacin, Population Pharmacokinetic, Biofilm
- Medical subject headings
- Osteomyelitis, Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 ofDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| All patients treated at the GHDCSS Reference Center for Complex Osteoarticular Infections for joint | Experimental | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration-Time Curve (AUC) of Rifampicin
Area under the plasma concentration-time curve of oral rifampicin, estimated using a population pharmacokinetic non-linear mixed-effects model (NONMEM).
Measured: Day 2/3, Day 8/10, and Day 28/32 post-initiation of antibiotic therapy
Peak Plasma Concentration (Cmax) of Rifampicin
Maximum observed plasma concentration (Cmax) of oral rifampicin, measured following administration.
Measured: Day 2/3, Day 8/10, and Day 28/32 post-initiation of antibiotic therapy
Apparent Oral Clearance (CL/F) of Rifampicin
Apparent oral clearance (CL/F) of rifampicin estimated using a population pharmacokinetic model (NONMEM), including evaluation of inter-individual variability and covariate effects.
Measured: Through 4 weeks post-initiation of antibiotic therapy
Apparent Volume of Distribution (V/F) of Rifampicin
Apparent volume of distribution (V/F) of rifampicin estimated using a population pharmacokinetic model (NONMEM), including evaluation of inter-individual variability and covariate effects.
Measured: Through 4 weeks post-initiation of antibiotic therapy
Secondary outcomes (7)
Incidence of Clinical and Biological Adverse Events Related to Rifampicin Exposure
Proportion of patients experiencing clinical or biological adverse events (recorded in CRF) evaluated in relation to rifampicin Cmax and AUC.
Measured: Through 4 weeks post-initiation of antibiotic therapy
Infection Relapse-Free Survival at 1 Year Relative to Rifampicin AUC/MIC Ratio
Time to staphylococcal infection relapse over a 1-year follow-up period, analyzed in relation to the rifampicin AUC/MIC (Minimum Inhibitory Concentration) ratio.
Measured: 12 months post-initiation of antibiotic therapy
Emergence of Rifampicin Resistance at Relapse
Assessment of rifampicin MIC (determined by E-test) at the time of infection relapse compared to baseline, evaluated according to Cmax/MIC and AUC/MIC ratios.
Measured: 12 months post-initiation of antibiotic therapy
Peak Plasma Concentration (Cmax) of Partner Antibiotic
Maximum observed plasma concentration (Cmax) of the partner antibiotic (levofloxacin or ciprofloxacin) administered in combination with rifampicin.
Measured: Day 8/10 and Day 28/32 post-initiation of antibiotic therapy
Trough Plasma Concentration (Cmin) of Partner Antibiotic
Trough plasma concentration (Cmin) of the partner antibiotic (levofloxacin or ciprofloxacin) measured prior to the next scheduled dose.
Measured: Day 8/10 and Day 28/32 post-initiation of antibiotic therapy
Apparent Clearance (CL/F) of Partner Antibiotic
Apparent clearance (CL/F) of the partner antibiotic (levofloxacin or ciprofloxacin) administered in combination with rifampicin.
Measured: Day 8/10 and Day 28/32 post-initiation of antibiotic therapy
Area Under the Plasma Concentration-Time Curve (AUC) of Partner Antibiotic
Area under the plasma concentration-time curve (AUC) of the partner antibiotic (levofloxacin or ciprofloxacin) administered in combination with rifampicin.
Measured: Day 8/10 and Day 28/32 post-initiation of antibiotic therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start10 Jun 2023
- Primary completionJun 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthetic Joint InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Diaconesses Croix Saint-Simon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788404
- Sponsor's protocol ID
- RIPH2-Ciné-RIF_CRIOA_1_2023
- Other IDs
- 2023-A00530-45
- Acronym
- Ciné-RIF
- Status last verified
- Aug 2026
- First submitted
- 6 May 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Pharmacokinetic Model of Rifampicin in Staphylococcal Osteoarticular Infections
- ClinicalTrials.gov ID
- NCT07788404
- Acronym / sponsor ID
- Ciné-RIF / RIPH2-Ciné-RIF_CRIOA_1_2023
- Keywords
- Rifampicin, Levofloxacin, Ciprofloxacin, Population Pharmacokinetic, Biofilm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Groupe Hospitalier Diaconesses Croix Saint-SimonUniversity, hospital or other
- Study start
- 10 Jun 2023 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Study Workflow and Pharmacokinetic Sampling Protocol:
Screening and Baseline: Adult patients hospitalized for staphylococcal prosthetic joint infection, chronic osteomyelitis, or native joint infection sensitive to rifampicin and levofloxacin/ciprofloxacin are screened. Clinical, demographic (age, sex, actual and ideal body weight), and biological data (renal function, liver function, serum albumin) are collected.
Pharmacokinetic Blood Sampling (12 samples total, 60 mL total volume): Day 2 / Day 3: 5 blood samples (5 mL each) collected pre-dose (t0, fasting) and at 1h, 2h, 4h, and 8h post-dose of rifampicin. Day 8 / Day 10: 5 blood samples (5 mL each) collected pre-dose (t0, fasting) and at 1h, 2h, 4h, and 8h post-dose of rifampicin and partner antibiotic (levofloxacin or ciprofloxacin). Day 28 / Day 32 (1-month follow-up visit): 2 blood samples (5 mL each) collected pre-dose and 2 hours post-dose during outpatient consultation.
Pharmacokinetic and Statistical Modeling: Population PK parameters (CL/F, V/F, ka) and inter-individual variability will be estimated using non-linear mixed-effects modeling (NONMEM v7.5). Influence of covariates (age, sex, weight, renal function, serum albumin) will be evaluated. One-Year Follow-up: Clinical follow-up at 12 months post-treatment initiation to evaluate infection relapse, tolerance, and microbiological
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients treated at the GHDCSS Reference Center for Complex Osteoarticular Infections for joint | Experimental | 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 ofThis 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. | Drug | All patients treated at the GHDCSS Reference Center for Complex Osteoarticular Infections for joint |
Primary outcome
Area Under the Plasma Concentration-Time Curve (AUC) of Rifampicin
Time frame: Day 2/3, Day 8/10, and Day 28/32 post-initiation of antibiotic therapy
Area under the plasma concentration-time curve of oral rifampicin, estimated using a population pharmacokinetic non-linear mixed-effects model (NONMEM).
Peak Plasma Concentration (Cmax) of Rifampicin
Time frame: Day 2/3, Day 8/10, and Day 28/32 post-initiation of antibiotic therapy
Maximum observed plasma concentration (Cmax) of oral rifampicin, measured following administration.
Apparent Oral Clearance (CL/F) of Rifampicin
Time frame: Through 4 weeks post-initiation of antibiotic therapy
Apparent oral clearance (CL/F) of rifampicin estimated using a population pharmacokinetic model (NONMEM), including evaluation of inter-individual variability and covariate effects.
Apparent Volume of Distribution (V/F) of Rifampicin
Time frame: Through 4 weeks post-initiation of antibiotic therapy
Apparent volume of distribution (V/F) of rifampicin estimated using a population pharmacokinetic model (NONMEM), including evaluation of inter-individual variability and covariate effects.
7 secondary outcomes
Incidence of Clinical and Biological Adverse Events Related to Rifampicin Exposure
Time frame: Through 4 weeks post-initiation of antibiotic therapy
Infection Relapse-Free Survival at 1 Year Relative to Rifampicin AUC/MIC Ratio
Time frame: 12 months post-initiation of antibiotic therapy
Emergence of Rifampicin Resistance at Relapse
Time frame: 12 months post-initiation of antibiotic therapy
Peak Plasma Concentration (Cmax) of Partner Antibiotic
Time frame: Day 8/10 and Day 28/32 post-initiation of antibiotic therapy
Trough Plasma Concentration (Cmin) of Partner Antibiotic
Time frame: Day 8/10 and Day 28/32 post-initiation of antibiotic therapy
Apparent Clearance (CL/F) of Partner Antibiotic
Time frame: Day 8/10 and Day 28/32 post-initiation of antibiotic therapy
Area Under the Plasma Concentration-Time Curve (AUC) of Partner Antibiotic
Time frame: Day 8/10 and Day 28/32 post-initiation of antibiotic therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Groupe hospitalier Diaconesses Croix Saint Simon
Paris, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 in people with Prosthetic Joint Infection and Osteomyelitis, run by Groupe Hospitalier Diaconesses Croix Saint-Simon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Plasma Concentration-Time Curve (AUC) of Rifampicin (time frame: Day 2/3, Day 8/10, and Day 28/32 post-initiation of antibiotic therapy). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.