Daptomycin With Rifampin for Treatment of Staphylococcal Prosthetic Joint Infection

NCT01144000 | Unknown Phase 2 DMC

• 1 other identifier: CCBC134ACH03T
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Staphylococcal Infections

Keywords

Prosthetic joint infection; daptomycin; staphylococcus

Outcome Measures

Primary Outcomes (1)

• Treatment efficacy (infection-free period)

  During study and 2 years after

Secondary Outcomes (2)

• Safety of daptomycin (incidence of side effects)

  During study and 2 years after

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

  during treatment (12 weeks)

Study Arms (1)

Daptomycin

EXPERIMENTAL

High dose Daptomycin in hip, knee and shoulder prosthesis infections

Drug: Daptomycin

Interventions

Daptomycin DRUG

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

Also known as: Cubicin

Daptomycin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Andrej Trampuz: lead
• University of Lausanne Hospitals: collaborator
• Kantonsspital Liestal: collaborator
• Schulthess Klinik: collaborator

Study Sites (3)

Centre hospitaliere universitaire vaudois (CHUV)

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Kantonsspital

Liestal, 4410, Switzerland

Location

Schulhess Clinic

Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Staphylococcal Infections

Interventions

Daptomycin

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Andrej Trampuz

  Centre hospitaliere universitaire vaudvoise (CHUV) University Hospital of Lausanne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrej Trampuz, MD

CONTACT

+41 21 314 3992; andrej.trampuz@chuv.ch

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: June 14, 2010
• First Posted: June 15, 2010
• Study Start: June 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2016
• Last Updated: June 26, 2012

Record last verified: 2012-06

Locations

CH (3)