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Daptomycin With Rifampin for Treatment of Staphylococcal Prosthetic Joint Infection (Dapto-Studie)

Primary Purpose

Staphylococcal Infections

Status

Unknown status

Phase

Phase 2

Locations

Switzerland

Study Type

Interventional

Intervention

Daptomycin

About this trial

This is an interventional treatment trial for Staphylococcal Infections focused on measuring Prosthetic joint infection, daptomycin, staphylococcus

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Centre hospitaliere universitaire vaudois (CHUV)
Kantonsspital
Schulhess Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Daptomycin

Arm Description

High dose Daptomycin in hip, knee and shoulder prosthesis infections

Outcomes

Primary Outcome Measures

Treatment efficacy (infection-free period)

Secondary Outcome Measures

Safety of daptomycin (incidence of side effects)

Population pharmacokinetic profile of antibiotics (daptomycin, rifampin) will be evaluated through concentration measurements in plasma and drainage fluid.

Full Information

NCT ID

NCT01144000

First Posted

June 14, 2010

Last Updated

June 24, 2012

Sponsor

Andrej Trampuz

Collaborators

University of Lausanne Hospitals, Kantonsspital Liestal, Schulthess Klinik

1. Study Identification

Unique Protocol Identification Number

NCT01144000

Brief Title

Daptomycin With Rifampin for Treatment of Staphylococcal Prosthetic Joint Infection

Acronym

Dapto-Studie

Official Title

Efficacy and Safety of Daptomycin (With or Without Rifampin) in the Treatment of Staphylococcal Hip, Knee and Shoulder Prosthetic Joint Infection

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Unknown status

Study Start Date

June 2012 (undefined)

Primary Completion Date

June 2014 (Anticipated)

Study Completion Date

June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Andrej Trampuz

Collaborators

University of Lausanne Hospitals, Kantonsspital Liestal, Schulthess Klinik

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Staphylococcal Infections

Keywords

Prosthetic joint infection, daptomycin, staphylococcus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Daptomycin

Arm Type

Experimental

Arm Description

High dose Daptomycin in hip, knee and shoulder prosthesis infections

Intervention Type

Drug

Intervention Name(s)

Daptomycin

Other Intervention Name(s)

Cubicin

Intervention Description

10mg/kg/24h i.v.(intravenous) for 2-3 weeks with/or without rifampin (depending if the prosthesis is removed or not)

Primary Outcome Measure Information:

Title

Treatment efficacy (infection-free period)

Time Frame

During study and 2 years after

Secondary Outcome Measure Information:

Title

Safety of daptomycin (incidence of side effects)

Time Frame

During study and 2 years after

Title

Population pharmacokinetic profile of antibiotics (daptomycin, rifampin) will be evaluated through concentration measurements in plasma and drainage fluid.

Time Frame

during treatment (12 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Andrej Trampuz, MD

Phone

+41 21 314 3992

andrej.trampuz@chuv.ch

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrej Trampuz

Organizational Affiliation

Centre hospitaliere universitaire vaudvoise (CHUV) University Hospital of Lausanne

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre hospitaliere universitaire vaudois (CHUV)

City

Lausanne

State/Province

Vaud

ZIP/Postal Code

1011

Country

Switzerland

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Andrej Trampuz

Phone

+41 (0)21 314 39 92

andrej.trampuz@chuv.ch

First Name & Middle Initial & Last Name & Degree

Olivier Borens

Facility Name

Kantonsspital

City

Liestal

ZIP/Postal Code

4410

Country

Switzerland

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Werner Zimmerli, MD

Phone

+41 61 925 1111

werner.zimmerli@ksli.ch

First Name & Middle Initial & Last Name & Degree

Martin Clauss, MD

martin.clauss@ksli.ch

First Name & Middle Initial & Last Name & Degree

Werner Zimmerli, MD

First Name & Middle Initial & Last Name & Degree

Martin Clauss, MD

Facility Name

Schulhess Clinic

City

Zurich

ZIP/Postal Code

8008

Country

Switzerland

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Markus Vogt, MD

markus.vogt@zgks.ch

First Name & Middle Initial & Last Name & Degree

Markus Vogt, MD

12. IPD Sharing Statement

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Daptomycin With Rifampin for Treatment of Staphylococcal Prosthetic Joint Infection

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