Daptomycin in the Treatment of Subjects With Infective Endocarditis or Bacteremia Due to S. Aureus
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)
Links
- Source: http://clinicaltrials.gov/show/NCT00093067
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2010-07-15T17:00:00-0400
Clinical Trials
The overall goals of this study are to compare the safety and efficacy of daptomycin monotherapy 10 mg/kg/day and vancomycin monotherapy dosed to achieve vancomycin trough levels of 15 to ...
Daptomycin as an Adjuvant Agent in the Treatment of Enterococcal Native Valve Endocarditis.
The aim of this study is to determine the safety and efficacy of daptomycin when used as an adjuvant agent to standard care in the treatment of proven native valve Enterococcal endocarditi...
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 trea...
Daptomycin for the Treatment of Severe Necrotizing Soft-Tissue Infections
Daptomycin is a new antimicrobial agent which has activity against resistant Gram positive cocci including MRSA. The phase 3 clinical trials for skin and soft tissue infections (SSTI) with...
How to Improve Diagnosis in Infective Endocarditis
The purpose is to exam prospective if simple clinical information in combination with a normal s-procalcitonin are sufficient for exclusion of infective endocarditis (IE).
PubMed Articles
Comparison of the Effects of Daptomycin on Bacterial and Model Membranes.
Daptomycin is a phosphatidylglycerol specific, calcium dependent membrane-active antibiotic that has been approved for the treatment of Gram-positive infections. A recent Bacillus subtilis study found...
Fungal endocarditis is reported less frequently than bacterial endocarditis, with an incidence of 0-12% of the total pediatric infective endocarditis.
Daptomycin is a cyclic lipopeptide effective against multidrug Gram-positive bacteria. Despite having a net negative charge, it is selective against negatively charged bacterial membranes. It has been...
Vancomycin-resistant enterococci are important pathogens for healthcare-associated infections. Although linezolid is bacteriostatic and daptomycin is rapidly bactericidal against vancomycin-resistant ...
High-dose daptomycin in patients with infective endocarditis or sternal wound infections.
Medical and Biotech [MESH] Definitions
Endocarditis, Subacute Bacterial
ENDOCARDIUM infection that is usually caused by STREPTOCOCCUS. Subacute infective endocarditis evolves over weeks and months with modest toxicity and rare metastatic infection.
Aggregatibacter Actinomycetemcomitans
A species of Gram-negative, facultatively anaerobic spherical or rod-shaped bacteria indigenous to dental surfaces. It is associated with PERIODONTITIS; BACTERIAL ENDOCARDITIS; and ACTINOMYCOSIS.
Aggregatibacter Aphrophilus
A species of Gram-negative, facultatively anaerobic spherical or rod-shaped bacteria indigenous to oral cavity and pharynx. It is associated with BACTERIAL ENDOCARDITIS; and MENINGITIS.
Serum Bactericidal Test
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.
Brain Abscess
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)
