Phase 2
N=75
Study of Daptomycin in Subjects Undergoing Surgery for Osteomyelitis Associated With an Infected Prosthetic Caused by Staphylococci
Osteomyelitis
Bottom Line
View on ClinicalTrials.gov: NCT00428844 ↗Enrolled (actual)
75
Serious AEs
27.0%
Results posted
Jun 2011
Primary outcome: Primary: Any Creatine Phosphokinase (CPK) Elevation > 500 Units Per Liter (U/L) — 4; 5; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- daptomycin (Drug); vancomycin (Drug); teicoplanin (Drug); nafcillin (Drug); oxacillin (Drug); flucloxacillin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Any Creatine Phosphokinase (CPK) Elevation > 500 Units Per Liter (U/L) |
4; 5; 2 | — |
| SECONDARY Safety - Notable Laboratory Abnormalities |
12; 10; 15; 10; 10; 12 | — |
| SECONDARY Overall Clinical Outcome |
13; 13; 8; 10; 8; 11 | — |
| SECONDARY Microbiological Response |
12; 12; 8; 8; 3; 6 | — |
| SECONDARY Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax) |
59.1; 92.3 | — |
| SECONDARY Pharmacokinetic Parameter: Area Under the Concentration-time Curve During a Dosing Interval at Steady State (AUCss) |
499; 821 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00428844). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.