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
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.
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)
Haemophilus Paraphrophilus
A species of gram-negative bacteria in the genus HAEMOPHILUS, found in the normal flora of the human ORAL CAVITY and PHARYNX. It can cause SUBACUTE BACTERIAL ENDOCARDITIS; and BRAIN ABSCESS, among other conditions.
Daptomycin
A cyclic lipopeptide antibiotic that inhibits GRAM-POSITIVE BACTERIA.
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...
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).
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...
PubMed Articles
ABSTRACT: BACKGROUND: Emergence of daptomycin-nonsusceptible (DNS) Staphylococcus aureus is a dreadful problem in the treatment of endocarditis. Few current therapeutic agents are effective for treati...
We report on an intravenous drug user who presented with methicillin-sensitive Staphylococcus aureus bacteremia and endocarditis of a prosthetic tricuspid valve, with a 4-cm vegetation refractory to s...
Possible daptomycin-induced organizing pneumonia.
We report a possible and rare case of drug-induced organizing pneumonia in a patient receiving daptomycin. A 75-year-old man with acute infective aorta valve endocarditis due to Enterococcus faecalis...
Daptomycin: a review of properties, clinical use, drug delivery and resistance.
Daptomycin is a branched cyclic anionic lipopeptide antibiotic that was discovered in the early 1980's but got the FDA approval only in 2003. This novel pharmaceutical molecule has demonstrated great...
Manipulation of kynurenine pathway for enhanced daptomycin production in Streptomyces roseosporus.
Daptomycin is a cyclic lipopeptide natural product produced by Stretptomyces roseosporus, displaying good bactericidal activity against a wide range of Gram-positive pathogens. Daptomycin contains a 1...
