Pharmacological Comparison of Continuous and Intermittent Infusions of Cloxacillin

• Status: Completed
• Trial end date: 2018-09-18
• Target enrollment: 0
• Participant gender: All

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 (BJI). Twelve patients suffering MSSA BJI will receive both administration modalities and serum concentrations of cloxacillin will be determined after 3 days of II and 3 days of continuous infusion in a prospective, randomized, open-label, monocentric crossover study design.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Nice
• Treatments: Anti-Bacterial Agents; Cloxacillin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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