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Completed

NCT Number: NCT00428844

Study of Daptomycin in Subjects Undergoing Surgery for Osteomyelitis Associated With an Infected Prosthetic Caused by Staphylococci

This is a research study designed to look at the efficacy and safety of daptomycin given at a dose of 6 mg/kg or 8 mg/kg in subjects being treated for prosthetic hip or knee infections caused by Staphylococci. These types of bacteria are among the most common types of bacteria causing infections of prosthetic joints.

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Key information

Conditions

Osteomyelitis Bone Diseases Bone Diseases, Infectious Infections Musculoskeletal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Federal National Institution of Science "Russian Ilizarov Scientific Center" "Restorative Traumatology and Orthopedics" of Rosmedtechnology, Kurgan, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject must be between the ages of 18 and 80, inclusive
  • Subject must have a diagnosis of prosthetic joint infection (PJI) in a hip or knee joint which has never previously been totally revised because of an infection and for which they are anticipated to undergo a two-stage replacement surgery
  • Subject must have a positive microbiological identifier of staphylococci.
  • If Subject is female of childbearing potential, must be willing to practice reliable birth control

Exclusion criteria

  • Subject has permanent intravascular prosthetic material such as heart valves or pacemakers
  • Subject has a creatinine clearance (CLCR) <30 mL/min as determined by the Cockcroft-Gault equation using actual body weight.
  • Subject has significant hepatic dysfunction
  • Subject has a fungal or mycobacterial PJI
  • Subject is known to be HIV-infected with CD4 count ≤ 200 cells/ mm3
  • Subject has an abnormal creatine phosphokinase (CPK) (elevated CPK level ≥ 2x ULN) at baseline as measured by central laboratory
  • Subject is currently under treatment with chemotherapeutic agents excluding chronic maintenance therapy (e.g. tamoxifen to prevent relapse of primary breast cancer)
  • Subject is pregnant, nursing, or lactating.
  • Subject is receiving or is expected to receive chronic immunosuppressive therapy during the study.

Treatment and study plan

daptomycin

Drug

6 mg/kg

Other names: Cubicin

Vancomycin

Drug

1 gram

Other names: Vancocin

Teicoplanin

Drug

6 mg/kg; used only at UK sites

Other names: Targocid

nafcillin

Drug

1-2 gram

Other names: Unipen

Oxacillin

Drug

1-2 gram

Other names: Bactocill

Flucloxacillin

Drug

1-2 mg

Other names: Fluclox

Primary outcomes

  1. Any Creatine Phosphokinase (CPK) Elevation > 500 Units Per Liter (U/L)

    Time frame: From the 3rd day of therapy to 1 week post last dose (approximately week 7)

    Number of subjects with CPK >500 U/L between Day 3 and 7 days following the last dose of study medication (Day 7P) as measured by the central laboratory.

Secondary outcomes

  1. Safety - Notable Laboratory Abnormalities

    Time frame: From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)

    Summary of Notable Laboratory Abnormalities - description of the proportion of subjects within each treatment group that had clinical laboratory values outside the reference range.

  2. Overall Clinical Outcome

    Time frame: Approximately 6 weeks post last dose (approximately week 12)

    The sponsor determined overall clinical outcome based on blinded review of clinical, microbiological, and radiological response of the subject including, but not limited to, clinical signs and symptoms of PJI, microbiological assessments, radiographic findings, and surgical procedures performed. Subjects were a success if both clinical and microbiological responses were success. A subject who failed to respond clinically or microbiologically was a failure. If microbiological response was non-evaluable and/or clinical evaluation at TOC was not performed, the subject was non-evaluable.

  3. Microbiological Response

    Time frame: Approximately 6 weeks post last dose (approximately week 12)

    Sponsor's assessment of subject-level microbiological response at the test-of-cure visit for the modified Intent-to-Treat (mITT) population.

  4. Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax)

    Time frame: Day 4 (steady state)

    The pharmacokinetic (PK) parameters of daptomycin at steady state for the 6 mg/kg and 8 mg/kg dose groups. On treatment day 4, PK samples for daptomycin levels were to be obtained prior to start of daptomycin infusion (0 hr) and at 0.5 hr (end of infusion), 1-1.5 hr, 3-5 hr, 8-12 hr, and 24 hr after the start of daptomycin infusion.

  5. Pharmacokinetic Parameter: Area Under the Concentration-time Curve During a Dosing Interval at Steady State (AUCss)

    Time frame: Day 4 (steady state)

    The pharmacokinetic (PK) parameters of daptomycin at steady state for the 6 mg/kg and 8 mg/kg dose groups. On treatment day 4, PK samples for daptomycin levels were to be obtained prior to start of daptomycin infusion (0 hr) and at 0.5 hr (end of infusion), 1-1.5 hr, 3-5 hr, 8-12 hr, and 24 hr after the start of daptomycin infusion.

Sponsors and collaborators

Lead sponsor

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Industry

Registry information

Official study title

A Phase 2 Randomized Study Investigating the Safety, Efficacy and Pharmacokinetics of Daptomycin 6 mg/kg and 8 mg/kg Versus Comparator in the Treatment of Subjects Undergoing Surgical Standard of Care for Osteomyelitis Associated With an Infected Prosthetic Hip or Knee Joint Caused by Staphylococci

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jan 30, 2007
Registry last updated
Jan 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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