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Application of Daptomycin in MRSA Infected Diabetic Foot in Comparison to Vancomycin Treatment

NCT01199783 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2024-03-18

Study results available
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Summary

Objective of the study is to test whether Daptomycin (6 mg/kg bodyweight) is non-inferior in treatment of severe diabetic foot infections (MRSA) in comparison to antibiotic treatment with Vancomycin (effective blood-plasma concentration of 15 mg/l). In case of microbiologically confirmed gram-negative co-infection effective antibiotic treatment according to microbiologic analysis will be administered upon medical decision in both therapy groups. The study will be carried out as a randomized, open label study.

Conditions

  • Diabetic Foot

Interventions

DRUG

Daptomycin

Infusion (6 mg/kg/bodyweight) once daily

DRUG

Vancomycin

vancomycin once daily (effective blood-plasma concentration of 15 mg/L)

Sponsors & Collaborators

  • Ruhr University of Bochum

    lead OTHER

Principal Investigators

  • Diethelm Tschoepe, Prof Dr Dr · Herz- und Diabeteszentrum NRW

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
2011-07-31
Primary Completion
2013-10-31
Completion
2013-12-31

Countries

  • Germany

Study Locations

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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 NCT01199783 on ClinicalTrials.gov