Status:
COMPLETED
Pharmacological Comparison of Continuous and Intermittent Infusions of Cloxacillin
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Infection
Methicillin Susceptible Staphylococcus Aureus Infection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Our objective is to establish pharmacological equivalence of intermittent and continuous infusion of cloxacillin during methicillin-susceptible Staphylococcus aureus (MSSA) bone and joint infections (...
Detailed Description
Introduction Staphylococcus aureus is the main causative agent of bone and joint infections (BJI). More than 80% of the strains isolated in France are methicillin-susceptible (MSSA). During the early ...
Eligibility Criteria
Inclusion
- Staphylococcus aureus sensitive to methicillin and to be treated with cloxacillin by injectable antibiotic monotherapy For patients with Osteo-articular infection on material
- Presence of a fistula in contact with the prosthesis or implant.
- Pus in the joint or in contact with the prosthesis or implant
- Presence of at least 1 positive sample (1 sampling by articular puncture or 1 peroperative sampling or by blood culture)
- A histological analysis of the peri-prosthetic osteo-articular tissue which is the object of acute inflammation is a strong argument in favor of an Osteo-articular infection on material
- For spondylodiscitis
- Culture of a disco-vertebral biopsy puncture to isolate a methicillin sensitive S. aureus
- Positive haemocultures for S. aureus sensitive to methicillin with imaging examination (CT or MRI of the spine) showing images of spondylodiscitis
- For primitive arthritis :
- Culture of a positive methicillin-sensitive S. aureus articular fluid puncture
- Cultivation of a methicillin-sensitive S. aureus-positive surgical joint lavage fluid
- For osteitis the diagnosis is based on the following criterion:
- \*Culture of surgical specimens from a focal zone of methicillin-sensitive S. aureus-positive osteitis
Exclusion
- Allergy to betalactamines
- Taking penicillin M within 36 hours before inclusion Renal function impaired with a glomerular filtration rate measured by MDRD formula of less than 30 ml / min
- Patient with renal function expected to change within 6 days of inclusion
- Hepatocellular insufficiency, whatever the degree
- \*Methotrexate intake
- Polytransfused (more than 2 CGR) in the previous week
- Patients requiring resuscitation
Key Trial Info
Start Date :
November 23 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 18 2018
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03246360
Start Date
November 23 2017
End Date
September 18 2018
Last Update
April 22 2019
Active Locations (1)
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1
CHU de Nice
Nice, France