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

NCT00428844 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2018-01-31

Study results available
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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.

Conditions

  • Osteomyelitis

Interventions

DRUG

daptomycin

6 mg/kg

DRUG

daptomycin

8 mg/kg

DRUG

vancomycin

1 gram

DRUG

teicoplanin

6 mg/kg; used only at UK sites

DRUG

nafcillin

1-2 gram

DRUG

oxacillin

1-2 gram

DRUG

flucloxacillin

1-2 mg

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

  • Alistair Wheeler, MD · Cubist Pharmaceuticals, 65 Hayden Ave, Lexington, MA 02421, USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-26
Primary Completion
2010-03-26
Completion
2010-06-23

Countries

  • United States
  • Russia
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00428844 on ClinicalTrials.gov