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Phase 4 Efficacy and Safety Study of Cubicin® With and Without Combination Therapy in S. Aureus Infective Endocarditis (SAIE)

NCT00638157 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-02-02

Study results available
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Summary

multicenter, randomized, double blind study to describe the safety and efficacy of daptomycin (6 mg/kg q24h) with and without concomitant initial gentamicin combination therapy in the treatment of SAIE

Conditions

  • Infective Endocarditis

Interventions

DRUG

daptomycin

Intravenous (i.v.) 6 mg/kg q24h

DRUG

daptomycin and gentamicin

i.v. daptomycin 6 mg/kg q24h plus initial i.v. gentamicin

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

  • Paula Bokesch, M.D. · Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-13
Primary Completion
2011-11-09
Completion
2011-11-09

Countries

  • United States

Study Locations

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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 NCT00638157 on ClinicalTrials.gov