Staphylococcal InfectionsPhase 2Dapto-StudieNCT01144000
Daptomycin With Rifampin for Treatment of Staphylococcal Prosthetic Joint Infection
A Phase 2 study testing Daptomycin in people with Staphylococcal Infections, run by Andrej Trampuz at 3 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Staphylococcal Infections
- What is being tested?
- Daptomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesSwitzerland
- Study dates
- Jun 2012to Jun 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
Centre hospitaliere universitaire vaudois (CHUV)
Lausanne, Canton of Vaud, 1011
Andrej Trampuz, +41 (0)21 314 39 92, andrej.trampuz@chuv.ch
Olivier Borens
Kantonsspital
Liestal, 4410
Werner Zimmerli, MD, +41 61 925 1111, werner.zimmerli@ksli.ch
Martin Clauss, MD, martin.clauss@ksli.ch
Schulhess Clinic
Zurich, 8008
Markus Vogt, MD, markus.vogt@zgks.ch
Markus Vogt, MD
About this study
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.
Read the 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.
- Conditions
- Staphylococcal Infections
- Being tested
- Daptomycin
- Keywords
- Prosthetic joint infection, daptomycin, staphylococcus
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaptomycinDrug
Also called Cubicin
10mg/kg/24h i.v.(intravenous) for 2-3 weeks with/or without rifampin (depending if the prosthesis is removed or not)
| Study group | Role | What they receive |
|---|---|---|
| Daptomycin | Experimental | High dose Daptomycin in hip, knee and shoulder prosthesis infections Receives: Drug: Daptomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment efficacy (infection-free period)
Measured: During study and 2 years after
Secondary outcomes (2)
Safety of daptomycin (incidence of side effects)
Measured: During study and 2 years after
Population pharmacokinetic profile of antibiotics (daptomycin, rifampin) will be evaluated through concentration measurements in plasma and drainage fluid.
Measured: during treatment (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2010 (estimated)
- Study startJun 2012
- Primary completionJun 2014 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcal InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andrej Trampuz
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lausanne Hospitals, Kantonsspital Liestal, Schulthess Klinik
- Responsible party
- Sponsor-investigator, Andrej Trampuz, Centre Hospitalier Universitaire Vaudois
- Investigators
- Andrej Trampuz, Principal investigator, Centre hospitaliere universitaire vaudvoise (CHUV) University Hospital of Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01144000
- Sponsor's protocol ID
- CCBC134ACH03T
- Acronym
- Dapto-Studie
- Status last verified
- Jun 2012
- First submitted
- 14 Jun 2010
- Last updated
- 26 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Daptomycin (With or Without Rifampin) in the Treatment of Staphylococcal Hip, Knee and Shoulder Prosthetic Joint Infection
- ClinicalTrials.gov ID
- NCT01144000
- Acronym / sponsor ID
- Dapto-Studie / CCBC134ACH03T
- Conditions
- Staphylococcal Infections
- Keywords
- Prosthetic joint infection, daptomycin, staphylococcus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Andrej TrampuzUniversity, hospital or other
- Collaborators
- University of Lausanne Hospitals, Kantonsspital Liestal, Schulthess Klinik
- Study start
- Jun 2012
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 15 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daptomycin | Experimental | Drug: DaptomycinHigh dose Daptomycin in hip, knee and shoulder prosthesis infections |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (11 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DaptomycinAlso: Cubicin10mg/kg/24h i.v.(intravenous) for 2-3 weeks with/or without rifampin (depending if the prosthesis is removed or not) | Drug | Daptomycin |
Primary outcome
Treatment efficacy (infection-free period)
Time frame: During study and 2 years after
2 secondary outcomes
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrej Trampuz principal investigator
Centre hospitaliere universitaire vaudvoise (CHUV) University Hospital of Lausanne
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Daptomycin in people with Staphylococcal Infections, run by Andrej Trampuz at 3 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrej Trampuz, MD (+41 21 314 3992, andrej.trampuz@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment efficacy (infection-free period) (time frame: During study and 2 years after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2012.