Staphylococcal Infections Clinical Trial
Official title:
Efficacy and Safety of Daptomycin (With or Without Rifampin) in the Treatment of Staphylococcal Hip, Knee and Shoulder Prosthetic Joint Infection
To determine the outcome and safety of a combined antimicrobial treatment involving daptomycin and surgical approach involving retention or short-interval two-stage exchange of the implant. Patients with hip, knee and shoulder Prosthetic Joint Infection (PJI) caused by methicillin-susceptible and methicillin-resistant staphylococci will be included and followed during 2 years.
In this prospective open observational clinical study (phase 2) patients with hip, knee and
shoulder PJI (as defined below) caused by methicillin-susceptible and methicillin-resistant
staphylococci will be included. An informed consent will be obtained prior to patient
inclusion. Medical records will be prospectively abstracted for demographic characteristics,
clinical, radiographic, laboratory and microbiologic data using a standardized case report
form (CRF). After inclusion, intravenous daptomycin 10 mg/kg (calculated as actual body
weight) is given once daily for 2-3 weeks, followed by oral rifampin-containing antibiotics
for a total of 3 months (as outlined below).
Two surgical modalities will be applied according to the PJI treatment algorithm:
- Open debridement and retention of the prosthesis (change of mobile parts): daptomycin
will be combined with rifampin.
- Two-stage exchange of the prosthesis with a short interval (2-3 weeks): daptomycin of
the prosthesis: daptomycin will be used alone.
The decision whether the implant will be retained or removed is based on objective criteria
of the treatment algorithm and is not subject to bias. All consecutive patients with a
staphylococcal PJI infection of the hip, knee or shoulder prosthesis will be included, if no
exclusion criterion is present, obviating the selection bias. Since not many specialized
institutions are treating patients with PJI, we expect low number of patients.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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