Daptomycin With Rifampin for Treatment of Staphylococcal Prosthetic Joint Infection (Dapto-Studie)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01144000|
Recruitment Status : Unknown
Verified June 2012 by Andrej Trampuz, Centre Hospitalier Universitaire Vaudois.
Recruitment status was: Not yet recruiting
First Posted : June 15, 2010
Last Update Posted : June 26, 2012
|Condition or disease||Intervention/treatment||Phase|
|Staphylococcal Infections||Drug: Daptomycin||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety of Daptomycin (With or Without Rifampin) in the Treatment of Staphylococcal Hip, Knee and Shoulder Prosthetic Joint Infection|
|Study Start Date :||June 2012|
|Estimated Primary Completion Date :||June 2014|
|Estimated Study Completion Date :||June 2016|
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
- Treatment efficacy (infection-free period) [ Time Frame: During study and 2 years after ]
- Safety of daptomycin (incidence of side effects) [ Time Frame: During study and 2 years after ]
- Population pharmacokinetic profile of antibiotics (daptomycin, rifampin) will be evaluated through concentration measurements in plasma and drainage fluid. [ Time Frame: during treatment (12 weeks) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01144000
|Contact: Andrej Trampuz, MD||+41 21 314 firstname.lastname@example.org|
|Centre hospitaliere universitaire vaudois (CHUV)||Not yet recruiting|
|Lausanne, Vaud, Switzerland, 1011|
|Contact: Andrej Trampuz +41 (0)21 314 39 92 email@example.com|
|Principal Investigator: Olivier Borens|
|Kantonsspital||Not yet recruiting|
|Liestal, Switzerland, 4410|
|Contact: Werner Zimmerli, MD +41 61 925 1111 firstname.lastname@example.org|
|Contact: Martin Clauss, MD email@example.com|
|Principal Investigator: Werner Zimmerli, MD|
|Sub-Investigator: Martin Clauss, MD|
|Schulhess Clinic||Not yet recruiting|
|Zurich, Switzerland, 8008|
|Contact: Markus Vogt, MD firstname.lastname@example.org|
|Principal Investigator: Markus Vogt, MD|
|Principal Investigator:||Andrej Trampuz||Centre hospitaliere universitaire vaudvoise (CHUV) University Hospital of Lausanne|