Informations générales (source: ClinicalTrials.gov)
Prospective,Randomized,Open Label,European Multicenter Study of the Efficacy of the Linezolid-rifampin Combination Versus Standard of Care in the Treatment of Gram-positive. (LIZ-BONE)
Interventional
Phase 2
University Hospital, Tours (Voir sur ClinicalTrials)
octobre 2012
avril 2016
29 juin 2024
The purpose of this study is to evaluate the efficacy of oral linezolid-rifampin
combination therapy (over 4 or 6 weeks) versus the standard of care in the treatment of
Gram-positive prosthetic hip joint infection with a one-stage surgical treatment.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Centre de Chirurgie Orthopédique et de la Main - 67400 - Strasbourg - France | Jeannot GAUDIAS | Contact (sur clinicalTrials) | |||
| CHRU de Tours - 37044 - Tours - Indre et Loire - France | Louis BERNARD | Contact (sur clinicalTrials) | |||
| CHU de Nantes - Nantes - France | David BOUTOILLE | Contact (sur clinicalTrials) | |||
| CHU de Poitiers - Poitiers - France | Gwenaël LE MOAL | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CH de Tourcoing - 59208 - Tourcoing - France | Eric SENNEVILLE | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
1. Men or women ≥ 18 to ≤ 80 years of age, weight ≥ 40 kg, BMI < 35, who have received
a diagnosis of chronic PJI (lasting more than 4 weeks but less than 24 months)
requiring a one-stage surgical procedure and presenting at least ONE of the
following clinical signs and symptoms:
1. Joint pain
2. Effusion
3. Erythema and sensation of heat at the implant site
4. Limited range of motion in the affected joint
2. Intraoperative microbiological specimens: during the surgical resection, 5 separate
surgical specimens (at least 3) must be sent for culture and susceptibility testing.
These specimens must be taken from different locations such as: Hip capsule, femoral
membrane, acetabular membrane, synovium, and synovial fluid with separate
instruments. A minimum of 2 surgical specimens must be positive. If a preoperative
puncture revealed the presence of an acceptable (Gram+) pathogen, it is acceptable
if only one pathogen similar to the previously revealed one is identified during the
surgical procedure.
3. Documented presence of Gram-positive bacteria as sole pathogen responsible for the
infection.
Note: This criterion must be verified after obtaining the results of the
susceptibility test performed on the specimens taken during the surgical procedure.
The verification will occur between Day 2 and Day 7 of the study.
4. All patients must undergo 1-stage revision surgery.
5. IRB or IEC approved informed consent form signed and dated. Informed consent will be
obtained from each patient before participation in this research study. If any
patient is unable to give consent, it may be obtained from the patient's next of kin
or legal representative in accordance with current laws and regulations.
6. Willing and able to comply with scheduled visits, up to 6 weeks of treatment with
the study antibiotics, laboratory tests, and other study procedures.
7. Patient entitled to Health System benefits or other such benefits
1. Men or women ≥ 18 to ≤ 80 years of age, weight ≥ 40 kg, BMI < 35, who have received
a diagnosis of chronic PJI (lasting more than 4 weeks but less than 24 months)
requiring a one-stage surgical procedure and presenting at least ONE of the
following clinical signs and symptoms:
1. Joint pain
2. Effusion
3. Erythema and sensation of heat at the implant site
4. Limited range of motion in the affected joint
2. Intraoperative microbiological specimens: during the surgical resection, 5 separate
surgical specimens (at least 3) must be sent for culture and susceptibility testing.
These specimens must be taken from different locations such as: Hip capsule, femoral
membrane, acetabular membrane, synovium, and synovial fluid with separate
instruments. A minimum of 2 surgical specimens must be positive. If a preoperative
puncture revealed the presence of an acceptable (Gram+) pathogen, it is acceptable
if only one pathogen similar to the previously revealed one is identified during the
surgical procedure.
3. Documented presence of Gram-positive bacteria as sole pathogen responsible for the
infection.
Note: This criterion must be verified after obtaining the results of the
susceptibility test performed on the specimens taken during the surgical procedure.
The verification will occur between Day 2 and Day 7 of the study.
4. All patients must undergo 1-stage revision surgery.
5. IRB or IEC approved informed consent form signed and dated. Informed consent will be
obtained from each patient before participation in this research study. If any
patient is unable to give consent, it may be obtained from the patient's next of kin
or legal representative in accordance with current laws and regulations.
6. Willing and able to comply with scheduled visits, up to 6 weeks of treatment with
the study antibiotics, laboratory tests, and other study procedures.
7. Patient entitled to Health System benefits or other such benefits
1. Concerning women of childbearing age:
1. intake of oral contraceptives (estroprogestins and progestins)
2. unability to use adequate mechanical contraceptive precautions
3. a positive pregnancy test result within 72 hours prior to randomization
4. 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 upper or egal to 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.