Status:
UNKNOWN
Daptomycin With Rifampin for Treatment of Staphylococcal Prosthetic Joint Infection
Lead Sponsor:
Andrej Trampuz
Collaborating Sponsors:
University of Lausanne Hospitals
Kantonsspital Liestal
Conditions:
Staphylococcal Infections
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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 w...
Detailed Description
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 wi...
Eligibility Criteria
Inclusion
- Informed consent has been obtained;
- Subject is 18-80 years of age;
- Subject has a PJI of the hip, knee and shoulder prosthesis caused by Staphylococcus aureus or coagulase-negative staphylococci (CNS) susceptible to daptomycin and rifampin;
- Surgical approach: Debridement and retention of the prosthesis OR a two-stage prosthesis exchange with a short interval (2-3 weeks). The selection of the surgical procedure is performed according to the PJI treatment algorithm;
- Subject is willing to participate in the study, to follow protocol study treatment regimen, and to comply with all planned follow-up assessments;
- Females of childbearing potential are willing to practice reliable birth control measures other than oral contraceptives (e.g., condoms or diaphragms together with a spermicidal foam or gel) and willing to undergo a urine pregnancy test prior to study entry.
Exclusion
- Significant renal insufficiency (creatinine clearance rate ≤30 ml/min, as determined by the Cockcroft-Gault equation at inclusion);
- Significant hepatic dysfunction at inclusion (AST or ALT ≥4 x upper limit of normal value);
- Elevated creatin phosphokinase (CPK) ≥2 x upper limit of normal value at inclusion
- PJI caused by additional microorganism;
- Non-adherence to the PJI treatment algorithm (see below);
- Subject has been previously enrolled in the study or is currently enrolled in another investigational study previously enrolled in the study or is currently enrolled in another investigational study, which deviates from the treatment algorithm;
- Subject had prior exposure to daptomycin within the past 3 months;
- Allergy or intolerance to daptomycin or rifampin, known hypersensitivity;
- Body mass index (BMI) \>45 kg/m²;
- Subject is pregnant, nursing or lactating;
- Inability to read and understand the participant's information.
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2016
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01144000
Start Date
June 1 2012
End Date
June 1 2016
Last Update
June 26 2012
Active Locations (3)
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1
Centre hospitaliere universitaire vaudois (CHUV)
Lausanne, Canton of Vaud, Switzerland, 1011
2
Kantonsspital
Liestal, Switzerland, 4410
3
Schulhess Clinic
Zurich, Switzerland, 8008