Daptomycin With Rifampin for Treatment of Staphylococcal Prosthetic Joint Infection (Dapto-Studie)
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Efficacy and Safety of Daptomycin (With or Without Rifampin) in the Treatment of Staphylococcal Hip, Knee and Shoulder Prosthetic Joint Infection|
- Treatment efficacy (infection-free period) [ Time Frame: During study and 2 years after ] [ Designated as safety issue: No ]
- Safety of daptomycin (incidence of side effects) [ Time Frame: During study and 2 years after ] [ Designated as safety issue: Yes ]
- Population pharmacokinetic profile of antibiotics (daptomycin, rifampin) will be evaluated through concentration measurements in plasma and drainage fluid. [ Time Frame: during treatment (12 weeks) ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
High dose Daptomycin in hip, knee and shoulder prosthesis infections
10mg/kg/24h i.v.(intravenous) for 2-3 weeks with/or without rifampin (depending if the prosthesis is removed or not)
Other Name: Cubicin
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01144000
|Contact: Andrej Trampuz, MD||+41 21 314 email@example.com|
|Centre hospitaliere universitaire vaudois (CHUV)||Not yet recruiting|
|Lausanne, Vaud, Switzerland, 1011|
|Contact: Andrej Trampuz +41 (0)21 314 39 92 firstname.lastname@example.org|
|Principal Investigator: Olivier Borens|
|Kantonsspital||Not yet recruiting|
|Liestal, Switzerland, 4410|
|Contact: Werner Zimmerli, MD +41 61 925 1111 email@example.com|
|Contact: Martin Clauss, MD firstname.lastname@example.org|
|Principal Investigator: Werner Zimmerli, MD|
|Sub-Investigator: Martin Clauss, MD|
|Schulhess Clinic||Not yet recruiting|
|Zurich, Switzerland, 8008|
|Contact: Markus Vogt, MD email@example.com|
|Principal Investigator: Markus Vogt, MD|
|Principal Investigator:||Andrej Trampuz||Centre hospitaliere universitaire vaudvoise (CHUV) University Hospital of Lausanne|