- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01144000
Daptomycin With Rifampin for Treatment of Staphylococcal Prosthetic Joint Infection (Dapto-Studie)
Efficacy and Safety of Daptomycin (With or Without Rifampin) in the Treatment of Staphylococcal Hip, Knee and Shoulder Prosthetic Joint Infection
Study Overview
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 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
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Andrej Trampuz, MD
- Phone Number: +41 21 314 3992
- Email: andrej.trampuz@chuv.ch
Study Locations
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Liestal, Switzerland, 4410
- Kantonsspital
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Contact:
- Werner Zimmerli, MD
- Phone Number: +41 61 925 1111
- Email: werner.zimmerli@ksli.ch
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Contact:
- Martin Clauss, MD
- Email: martin.clauss@ksli.ch
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Principal Investigator:
- Werner Zimmerli, MD
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Sub-Investigator:
- Martin Clauss, MD
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Zurich, Switzerland, 8008
- Schulhess Clinic
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Contact:
- Markus Vogt, MD
- Email: markus.vogt@zgks.ch
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Principal Investigator:
- Markus Vogt, MD
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Vaud
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Lausanne, Vaud, Switzerland, 1011
- Centre hospitaliere universitaire vaudois (CHUV)
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Contact:
- Andrej Trampuz
- Phone Number: +41 (0)21 314 39 92
- Email: andrej.trampuz@chuv.ch
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Principal Investigator:
- Olivier Borens
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Daptomycin
High dose Daptomycin in hip, knee and shoulder prosthesis infections
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10mg/kg/24h i.v.(intravenous) for 2-3 weeks with/or without rifampin (depending if the prosthesis is removed or not)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Treatment efficacy (infection-free period)
Time Frame: During study and 2 years after
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During study and 2 years after
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety of daptomycin (incidence of side effects)
Time Frame: During study and 2 years after
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During study and 2 years after
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Population pharmacokinetic profile of antibiotics (daptomycin, rifampin) will be evaluated through concentration measurements in plasma and drainage fluid.
Time Frame: during treatment (12 weeks)
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during treatment (12 weeks)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Andrej Trampuz, Centre hospitaliere universitaire vaudvoise (CHUV) University Hospital of Lausanne
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCBC134ACH03T
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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