[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653507":3},{"organization":4,"outcomesModule":7,"designInfo":48,"detailedDescription":54,"studyPopulation":47,"armGroups":55,"interventions":61,"overallOfficials":47,"centralContacts":47,"locations":67,"responsibleParty":90,"collaborators":47,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":47,"enrollmentInfo":101,"targetDuration":47,"studyType":104,"phases":105,"briefSummary":106,"conditions":107,"keywords":111,"overallStatus":70,"whyStopped":47,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Groupe Hospitalier Diaconesses Croix Saint-Simon","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":23,"otherOutcomes":47},[9,13,16,20],{"measure":10,"description":11,"timeFrame":12},"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).","Day 2\u002F3, Day 8\u002F10, and Day 28\u002F32 post-initiation of antibiotic therapy",{"measure":14,"description":15,"timeFrame":12},"Peak Plasma Concentration (Cmax) of Rifampicin","Maximum observed plasma concentration (Cmax) of oral rifampicin, measured following administration.",{"measure":17,"description":18,"timeFrame":19},"Apparent Oral Clearance (CL\u002FF) of Rifampicin","Apparent oral clearance (CL\u002FF) of rifampicin estimated using a population pharmacokinetic model (NONMEM), including evaluation of inter-individual variability and covariate effects.","Through 4 weeks post-initiation of antibiotic therapy",{"measure":21,"description":22,"timeFrame":19},"Apparent Volume of Distribution (V\u002FF) of Rifampicin","Apparent volume of distribution (V\u002FF) of rifampicin estimated using a population pharmacokinetic model (NONMEM), including evaluation of inter-individual variability and covariate effects.",[24,27,31,34,38,41,44],{"measure":25,"description":26,"timeFrame":19},"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.",{"measure":28,"description":29,"timeFrame":30},"Infection Relapse-Free Survival at 1 Year Relative to Rifampicin AUC\u002FMIC Ratio","Time to staphylococcal infection relapse over a 1-year follow-up period, analyzed in relation to the rifampicin AUC\u002FMIC (Minimum Inhibitory Concentration) ratio.","12 months post-initiation of antibiotic therapy",{"measure":32,"description":33,"timeFrame":30},"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\u002FMIC and AUC\u002FMIC ratios.",{"measure":35,"description":36,"timeFrame":37},"Peak Plasma Concentration (Cmax) of Partner Antibiotic","Maximum observed plasma concentration (Cmax) of the partner antibiotic (levofloxacin or ciprofloxacin) administered in combination with rifampicin.","Day 8\u002F10 and Day 28\u002F32 post-initiation of antibiotic therapy",{"measure":39,"description":40,"timeFrame":37},"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.",{"measure":42,"description":43,"timeFrame":37},"Apparent Clearance (CL\u002FF) of Partner Antibiotic","Apparent clearance (CL\u002FF) of the partner antibiotic (levofloxacin or ciprofloxacin) administered in combination with rifampicin.",{"measure":45,"description":46,"timeFrame":37},"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.",null,{"allocation":49,"interventionModel":50,"interventionModelDescription":47,"primaryPurpose":51,"observationalModel":47,"timePerspective":47,"maskingInfo":52},"NA","SINGLE_GROUP","TREATMENT",{"masking":53,"maskingDescription":47,"whoMasked":47},"NONE","Study Workflow and Pharmacokinetic Sampling Protocol:\n\nScreening and Baseline: Adult patients hospitalized for staphylococcal prosthetic joint infection, chronic osteomyelitis, or native joint infection sensitive to rifampicin and levofloxacin\u002Fciprofloxacin are screened. Clinical, demographic (age, sex, actual and ideal body weight), and biological data (renal function, liver function, serum albumin) are collected.\n\nPharmacokinetic Blood Sampling (12 samples total, 60 mL total volume): Day 2 \u002F 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 \u002F 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 \u002F Day 32 (1-month follow-up visit): 2 blood samples (5 mL each) collected pre-dose and 2 hours post-dose during outpatient consultation.\n\nPharmacokinetic and Statistical Modeling: Population PK parameters (CL\u002FF, V\u002FF, 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",[56],{"label":57,"type":58,"description":47,"interventionNames":59},"All patients treated at the GHDCSS Reference Center for Complex Osteoarticular Infections for joint","EXPERIMENTAL",[60],"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",[62],{"type":63,"name":64,"description":65,"armGroupLabels":66,"otherNames":47},"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.",[57],[68],{"facility":69,"status":70,"city":71,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"Groupe hospitalier Diaconesses Croix Saint Simon","RECRUITING","Paris","75020","France","FR",{"type":76,"coordinates":77},"Point",[78,79],2.3488,48.85341,{"lat":79,"lon":78},[82,87],{"name":83,"role":84,"phone":85,"phoneExt":47,"email":86},"Younes KERROUMI, Clinical Research Physician","CONTACT","0033144643384","ykerroumi@hopital-dcss.org",{"name":88,"role":89,"phone":47,"phoneExt":47,"email":47},"Valerie ZELLER, Infectious disease specialist","PRINCIPAL_INVESTIGATOR",{"type":91,"investigatorFullName":47,"investigatorTitle":47,"investigatorAffiliation":47,"oldNameTitle":47,"oldOrganization":47},"SPONSOR","100653507","population-pharmacokinetic-model-of-rifampicin-in-staphylococcal-osteoarticular-infections-100653507",false,"NCT07788404","Population Pharmacokinetic Model of Rifampicin in Staphylococcal Osteoarticular Infections","Ciné-RIF","Inclusion Criteria:\n\n* Patient informed about the study and signed written consent obtained\n* Male or female participant aged 18 years or older\n* Staphylococcal osteoarticular infection (prosthetic joint infection of hip, knee, or shoulder; chronic osteomyelitis; or native joint infection) susceptible to rifampicin and levofloxacin or ciprofloxacin\n* Indication for combined medico-surgical treatment of the osteoarticular infection\n\nExclusion Criteria:\n\n* Septic shock requiring vasopressor support\n* Prior rifampicin treatment within 1 month preceding inclusion\n* Contraindication to rifampicin (known allergy, major drug interaction, or hepatic cirrhosis)\n* End-stage renal disease on chronic dialysis\n* Pregnant or breastfeeding woman\n* Adult patient unable or unfit to give informed consent\n* Subject deprived of liberty by judicial or administrative decision\n* Subject not affiliated with or beneficiary of a national social security scheme","ALL","18 Years",{"count":102,"type":103},40,"ESTIMATED","INTERVENTIONAL",[49],"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:\n\nThe 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\u002FMIC) and clinical\u002Fbiological tolerance, and assessing 1-year infection relapse-free survival and resistance emergence. Study Design:\n\nProspective, single-center, interventional study with minimal risks and constraints (RIPH 2) involving 40 participants recruited at the Reference Center for Complex Osteoarticular Infections (CRIOAC).",[108,109,110],"Prosthetic Joint Infection","Osteomyelitis","Staphylococcal Infections",[112,113,114,115,116],"Rifampicin","Levofloxacin","Ciprofloxacin","Population Pharmacokinetic","Biofilm","2026-08-24",{"date":119,"type":120},"2026-08-26","ACTUAL",{"date":122,"type":120},"2023-06-10",{"date":124,"type":103},"2029-06",{"name":5,"class":6},1]