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Daptomycin in the Treatment of Subjects With Infective Endocarditis or Bacteremia Due to S. Aureus

2010-07-15 17:00:00 | BioPortfolio

Summary

The purpose of this study is to compare the safety and efficacy of daptomycin, an antibiotic, to standard therapy in subjects who have infective endocarditis or bacteremia due to Staphylococcus aureus (S. aureus).

Description

Even with prompt treatment, Staphylococcus aureus Infective Endocarditis (IE) continues to be associated with significant morbidity and mortality indicating a need for new therapeutic approaches. In vitro, daptomycin is rapidly bactericidal, with concentration-dependent killing, and MIC90 of 0.5 g/ml for S. aureus; in clinical studies, daptomycin appears to be well tolerated and can be administered once every 24 hours by i.v. infusion. These characteristics suggest it should be clinically and microbiologically effective in the treatment of serious S. aureus infections, including IE and bacteremia

Comparison: standard of care (Vancomycin or Semi-synthetic Penicillin with adjunct gentamicin)

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Bacterial Endocarditis

Intervention

daptomycin

Status

Completed

Source

Cubist Pharmaceuticals

Results (where available)

View Results

Links

Published on BioPortfolio: 2010-07-15T17:00:00-0400

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Medical and Biotech [MESH] Definitions

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Method of measuring the bactericidal activity contained in a patient's serum as a result of antimicrobial therapy. It is used to monitor the therapy in BACTERIAL ENDOCARDITIS; OSTEOMYELITIS and other serious bacterial infections. As commonly performed, the test is a variation of the broth dilution test. This test needs to be distinguished from testing of the naturally occurring BLOOD BACTERICIDAL ACTIVITY.

A circumscribed collection of purulent exudate in the brain, due to bacterial and other infections. The majority are caused by spread of infected material from a focus of suppuration elsewhere in the body, notably the PARANASAL SINUSES, middle ear (see EAR, MIDDLE); HEART (see also ENDOCARDITIS, BACTERIAL), and LUNG. Penetrating CRANIOCEREBRAL TRAUMA and NEUROSURGICAL PROCEDURES may also be associated with this condition. Clinical manifestations include HEADACHE; SEIZURES; focal neurologic deficits; and alterations of consciousness. (Adams et al., Principles of Neurology, 6th ed, pp712-6)

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