Efficacy and Safety Study of Antibiotic Treatment to Treat Hip Prosthetic Joint Infection
NCT ID: NCT01757236
Last Updated: 2014-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
100 participants
INTERVENTIONAL
2012-10-31
2016-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment A
IV vancomycin (15mg/kg every 12 hours or in a continuous infusion) and IV ceftriaxone (2g daily) until Day 2 to 7 (until the susceptibility test results are obtained).
Patients with only a confirmed Gram-positive infection will continue the study and will receive standard of care antibiotic therapy including oral rifampin (10-15mg/kg every 12 hours) combined with either oral clindamycin (600 mg every 8 hours) or oral sulfamethoxazole and trimethoprim (800/160 mg every 8 hours) or oral fluoroquinolone (Ofloxacin 200 mg every 12 hours). The total duration of antibiotic therapy from the day of the surgical procedure until the end of treatment (EOT) will be 6 weeks.
VANCOMYCIN
CEFTRIAXONE
CLINDAMYCIN
SULFAMETHOXAZOLE AND TRIMETHOPRIM (CO-TRIMOXAZOLE)
FLUOROQUINOLONE
RIFAMPIN
Treatment B
IV vancomycin (15mg/kg every 12 hours or in a continuous infusion) and IV ceftriaxone (2g daily) until Day 2 to 7 (until the susceptibility test results are obtained).
Patients with only a confirmed Gram-positive infection will continue the study and will receive oral linezolid (600mg every 12 hours) combined with oral rifampin (10-15mg/kg every 12 hours).
The total duration of antibiotic therapy from the day of the surgical procedure until the end of treatment (EOT) will be 6 weeks.
VANCOMYCIN
CEFTRIAXONE
LINEZOLID
RIFAMPIN
Treatment C
IV linezolid (600 mg every 12 hours)and IV ceftriaxone (2g daily) until Day 2. Oral or IV rifampin (10-15 mg/kg every 12 hours) will be added 48 hours after initiating the study treatment. Treatment with the study drug will continue until Day 2 to 7 (until the susceptibility test results are obtained). Patients with only a confirmed Gram-positive infection will continue the study. Treatment with ceftriaxone will be discontinued and the patient will switch to oral linezolid and oral rifampin. The total duration of antibiotic therapy from the day of the surgical procedure until the end of treatment (EOT) will be 4 weeks.
VANCOMYCIN
CEFTRIAXONE
LINEZOLID
RIFAMPIN
Interventions
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VANCOMYCIN
CEFTRIAXONE
CLINDAMYCIN
SULFAMETHOXAZOLE AND TRIMETHOPRIM (CO-TRIMOXAZOLE)
FLUOROQUINOLONE
LINEZOLID
RIFAMPIN
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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.
18 Years
80 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
International Clinical Trials Association
OTHER
University Hospital, Tours
OTHER
Responsible Party
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Principal Investigators
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Louis BERNARD
Role: PRINCIPAL_INVESTIGATOR
CHRU de Tours FRANCE
David BOUTOILLE
Role: PRINCIPAL_INVESTIGATOR
CHU de Nantes FRANCE
Gwenael LE MOAL
Role: PRINCIPAL_INVESTIGATOR
CHU de Poitiers FRANCE
Matteo BASSETTI
Role: PRINCIPAL_INVESTIGATOR
Azienda Opedaliera Universitaria San Maria della Misericordia ITALY
Silvano ESPOSITO
Role: PRINCIPAL_INVESTIGATOR
Facolta di Medicina e Chirugia ITALY
Jeannot GAUDIAS
Role: PRINCIPAL_INVESTIGATOR
Centre de Chirurgie Orthopédique et de la Main FRANCE
Alex SORIANO
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinic of Barcelona SPAIN
Bartolome LLADO FERRER
Role: PRINCIPAL_INVESTIGATOR
Hospital Son Llatzer Palma Balears SPAIN
Mar SANCHEZ SOMOLINOS
Role: PRINCIPAL_INVESTIGATOR
HGU Gregorio Maranon Madrid SPAIN
Eric SENNEVILLE
Role: PRINCIPAL_INVESTIGATOR
CH de Tourcoing FRANCE
Locations
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CHRU de Tours
Tours, Indre et Loire, France
CHU de Nantes
Nantes, , France
CHU de Poitiers
Poitiers, , France
Centre de Chirurgie Orthopédique et de la Main
Strasbourg, , France
CH de Tourcoing
Tourcoing, , France
Azienda Opedaliera Universitaria San Maria della Misericordia
Udine, , Italy
Hospital Clinic of Barcelona
Barcelona, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Hospital Son Llatzer
Palma de Mallorca, , Spain
Countries
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Central Contacts
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Facility Contacts
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David BOUTOILLE
Role: primary
Gwenaël LE MOAL
Role: primary
Mar SANCHEZ SOMOLINOS
Role: primary
Bartolome LLADO FERRER
Role: primary
Other Identifiers
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2012-000781-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PHAO2011/LB/LIZ-BONE
Identifier Type: -
Identifier Source: org_study_id
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