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Outpatient Treatment of Gram Positive Wound Infections in the Diabetic Foot: A Pharmaco-economic Comparison of Daptomycin vs. Vancomycin Based Regimens

NCT01133600 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2013-09-10

No results posted yet for this study

Summary

The purpose of the study is to evaluate the overall burden to the participant (economic, quality of life, patients satisfaction and freedom from side effects) when treating Gram positive infections of the foot in diabetic adults with daptomycin versus vancomycin.

Conditions

  • Diabetic Foot

Interventions

DRUG

Cubicin

dosed at 6 mg/kg body weight intravenously every 24 hours with a reduction to 6mg/kg every other day if CrCl is \<30ml/min.

DRUG

Vancomycin

dosed at 15mg/kg intravenously every 12 hours with adjustments for renal function.

Sponsors & Collaborators

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

    collaborator INDUSTRY

  • Clinical Alliance for Research & Education - Infectious Diseases, LLC.

    lead OTHER

Principal Investigators

  • Donald Poretz, MD · Clinical Alliance for Research & Education - Infectious Diseases, LLC.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States

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 NCT01133600 on ClinicalTrials.gov