Hip prosthesis infected by gram-positive bacteria MedDRA version: 14.1 Level: LLT Classification code 10053021 Term: Gram-positive bacterial infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Zyvoxid
Product Name: LINEZOLID
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: LINEZOLID
CAS Number: 165800-03-3
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
Direction de la recherche clinique du centre hospitalier universitaire de Tours, Bretonneau
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients > or = 18 and = or or = 40 kg, BMI =65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: 1. Concerning women of childbearing age: - intake of oral contraceptives (estroprogestins and progestins), - unability to use adequate mechanical contraceptive precautions, - a positive pregnancy test result within 72 hours prior to randomization, - pregnant, or are currently breastfeeding and unwilling to discontinue breastfeeding during therapy. 2. Patients with a prosthetic joint infection caused by: Gram-negative, mixed Gram-negative and Gram-positive, fungal, or mycobacterial microorganisms. If a previous radiologically guided puncture has revealed the presence of a Gram-negative microorganism, the patient must not be enrolled in this study. 3. Platelet count less than 100×103/mm3 at the time of the examination performed during the screening period. 4. Hemoglobin < 9 g/dL at the time of the examination performed during the screening period. 5. Infection affecting several joints. 6. Rheumatological disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, etc.) 7. Previously diagnosed immune function disease(s) (e.g., AIDS), neutropenia (neutrophils < 1000/mm3). 8. Alcoholism or substance abuse sufficient, in the investigator?s judgment, to prevent treatment adherence to the study drug and/or follow-up. 9. Patients currently in peritoneal dialysis or receiving another treatment for renal failure (e.g., hemofiltration, CVVH). 10. Liver failure with alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) and/or total bilirubin levels < or = 5 times the upper limit of normal. 11. Patients with other concurrent serious infections such as: endocarditis, meningitis, or central nervous system (CNS) infections, decubitus and ischemic ulcers with underlying osteomyelitis, necrotizing fasciitis, gas gangrene. If suspected, these diagnoses must be ruled out prior to enrollment in the study. 12. Previous randomization in this protocol. 13. Not expected or not likely to survive for the entire duration of the treatment period and TOC (12 months after the end of treatment). 14. Hypersensitivity to the study drugs or their excipients, 15. Identification of a pathogen resistant to the investigational drugs. 16. patients treated with a protease inhibitor (e.g. indinavir, ritonavir), or with delavirdine, or with nevirapine, 17. Patients treated or having been treated within two weeks prior surgery with an MAOI (A or B), an antiserotonergic drug, a tricyclic antidepressant, an agonist of 5HT1-receptor (triptan), a direct or indirect sympathomimetic drug (including adrenergic bronchodilator, pseudoephedrin, phenylpropanolamin), a vasopressor (adrenalin, noradrenalin), dopaminergic drug, pethidin or buspirone, 18. Patients with a degenerative neurological disease (Parkinson?s disease, multiple sclerosis, Alzheimer?s disease, etc.). 19. Patient presenting an uncontrolled hypertension, a pheochromocytoma, a carcinoid syndrome, a hyperthyroidism, a bipolar depression, a dysthymic schizophrenia, an acute confusional state, pophyria or a history of retrobulbar optic neuritis, 20. Patient who is participating or has participated in a clinical trial in the month prior to the study screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to evaluate the efficacy of oral linezolid-rifampin combination therapy (over 4 or 6 weeks) versus standard of care therapy in the treatment of Gram-positive prosthetic Hip joint infection with one-stage surgical treatment.;Secondary Objective: The secondary objective is to assess the safety of the treatment regimens.;Primary end point(s): Primary endpoint will be the cure rate at 12 months post treatment (Test Of Cure) in the modified intent-to-treat population at the visit at the hospital. Patients will be declared cured if clinical signs of infection are normalized.;Timepoint(s) of evaluation of this end point: 12 month after the end of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints will be: 1. The cure rate at 12 months post treatment in the modified intent-to-treat population. Patients will be declared cured if radiological and biological signs of infection are normalized. 2. The cure rate at end of treatment, 6 months and 24 months post treatment in the modified intent-to-treat population and the per-protocol population, as well as at 12 months for the per-protocol population. Patients will be declared cured if clinical, radiological and biological signs of infection are normalized. 2. Safety assessment in the safety population.;Timepoint(s) of evaluation of this end point: 1. For the modified intent-to-treat population: at 12 months after the end of treatment. 2. For the modified intent-to-treat population: at end of treatment, 6 months and 24 months. For the per-protocol population: at end of treatment, 6 months, 12 months and 24 months. 3. During the hospitalization period starting the surgery and then at each phone call to the patient and at each visit until the end of the study (24 months after the end of the treatment). | — |
Countries
Italy, Spain, Switzerland
Contacts
Public ContactDirection de la recherche clinique
Centre hospitalier universitaire de Tours, Bretonneau
Outcome results
None listed