Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

New antibiotic proven effective to treat acute bacterial skin infections

05.06.2014

Clinical trial shows dalbavancin is as effective as vancomycin

A study published in today's New England Journal of Medicine reports that the antibiotic dalbavancin is as effective as vancomycin, the current standard-of-care antibiotic used to treat serious bacterial skin and skin-structure infections.

The study results establish dalbavancin as a therapy for Staphylococcus aureus infections, including methicillin-resistant S. aureus, or MRSA. Acute bacterial skin and skin-structure infections are among the most common reasons for the hospitalization of adults in the United States today, and the associated medical costs are substantial.

A team led by Helen Boucher, M.D., Associate Professor of Medicine at Tufts Medical Center, reports the results in an article titled "Once-weekly Dalbavancin versus daily conventional therapy for skin infections."

"Dalbavancin has a great likelihood of changing our practice in caring for patients with severe skin infections. It will now be possible to treat once a week instead of several times a day and will potentially remove the need for hospital admission and long-term intravenous catheters," Boucher said.

The team completed two clinical trials comparing efficacy of dalbavancin with vancomycin followed by linezolid. The Phase 3 studies, called non-inferiority trials, were conducted between 2011-2012. Titled DISCOVER 1 and DISCOVER 2 (Dalbavancin for Infections of the Skin COmpared to Vancomycin at an Early Response), the studies were conducted at 54 and 86 investigative sites, respectively, and were randomized, double-blind, double-dummy trials. (To insure against bias, double-dummy trials include two placebo arms when the study drugs are administered by different methods, for example, orally versus intravenously.)

For the trial, the diagnosis of acute bacterial skin and skin-structure infection required the presence of cellulitis, a major abscess or a wound infection, all with at least 75 square centimeters of surrounding redness. Additional criteria were elevated body temperature and white blood cell count.

For a period of 10-14 days, patients were given either once-weekly intravenous dalbavancin or twice-daily intravenous vancomycin followed by oral linezolid, along with dummy infusions or pills. The primary endpoint was early clinical response, defined as cessation of spread of infection-related reddening and inflammation of the skin and the absence of fever at 48 to 72 hours. Secondary endpoints measured at the conclusion of therapy included clinical status and investigator's assessment of outcome.

Data from the two DISCOVER trials were pooled. Analysis showed that 525 of 659 (79.7 percent) in the dalbavancin group and 521 of 653 (79.8 percent) in the vancomycin-linezolid group had an early clinical response, indicative of treatment success. For patients infected with Staphylococcus aureus, including MRSA, clinical success was seen in 90.6 percent of the dalbavancin-treated patients and 93.8 percent of those treated with vancomycin-linezolid.

Dr. Boucher explained, "The patients in our study were very ill: more than 85 percent had fever at entry and more than half had systemic inflammatory response syndrome. In addition, our patients had large infections with median areas of over 300 square centimeters. Our results establish dalbavancin as an effective therapy and prove non-inferiority of dalbavancin to vancomycin in the treatment of these serious infections."

In 2011, the Centers for Disease Control and Prevention identified antimicrobial resistance as a serious United States and global health concern. The DISCOVER trials were conducted with the help of the Generating Antibiotic Incentives Now (GAIN) provision of the 2012 Food and Drug Administration Safety and Innovation Act to stimulate development of new antibiotics to treat infections. Under the GAIN provisions, these drugs receive a priority review status and undergo an expedited regulatory approval process with FDA.

###

The trials were sponsored by Durata Therapeutics.

Additional authors of the study are Mark Wilcox, M.D., of the University of Leeds, United Kingdom; George H. Talbot of Talbot Advisors in Anna Maria, Florida; Sailaja Puttagunta, M.D., and Michael W. Dunne, M.D., of Durata Therapeutics, Branford, Connecticut; and Anita F. Das, Ph.D., of InClin in San Mateo, Calif.

About Tufts Medical Center

Tufts Medical Center is an exceptional, not-for-profit, 415-bed academic medical center that is home to both a full-service hospital for adults and Floating Hospital for Children. Conveniently located in downtown Boston, the Medical Center is the principal teaching hospital for Tufts University School of Medicine. Floating Hospital for Children is the full-service children's hospital of Tufts Medical Center and the principal pediatric teaching hospital of Tufts University School of Medicine. Tufts Medical Center is affiliated with the New England Quality Care Alliance, a network of nearly 1,800 physicians throughout Eastern Massachusetts. For more information, please visit http://www.tuftsmedicalcenter.org.

Julie Jette | Eurek Alert!

Further reports about: Medical Medicine Tufts antibiotic aureus bacterial drugs infections intravenous skin trials vancomycin

More articles from Studies and Analyses:

nachricht High in calories and low in nutrients when adolescents share pictures of food online
07.04.2016 | University of Gothenburg

nachricht Brain connectivity reveals hidden motives
04.03.2016 | Universität Zürich

All articles from Studies and Analyses >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Worldwide Success of Tyrolean Wastewater Treatment Technology

A biological and energy-efficient process, developed and patented by the University of Innsbruck, converts nitrogen compounds in wastewater treatment facilities into harmless atmospheric nitrogen gas. This innovative technology is now being refined and marketed jointly with the United States’ DC Water and Sewer Authority (DC Water). The largest DEMON®-system in a wastewater treatment plant is currently being built in Washington, DC.

The DEMON®-system was developed and patented by the University of Innsbruck 11 years ago. Today this successful technology has been implemented in about 70...

Im Focus: Computational high-throughput screening finds hard magnets containing less rare earth elements

Permanent magnets are very important for technologies of the future like electromobility and renewable energy, and rare earth elements (REE) are necessary for their manufacture. The Fraunhofer Institute for Mechanics of Materials IWM in Freiburg, Germany, has now succeeded in identifying promising approaches and materials for new permanent magnets through use of an in-house simulation process based on high-throughput screening (HTS). The team was able to improve magnetic properties this way and at the same time replaced REE with elements that are less expensive and readily available. The results were published in the online technical journal “Scientific Reports”.

The starting point for IWM researchers Wolfgang Körner, Georg Krugel, and Christian Elsässer was a neodymium-iron-nitrogen compound based on a type of...

Im Focus: Atomic precision: technologies for the next-but-one generation of microchips

In the Beyond EUV project, the Fraunhofer Institutes for Laser Technology ILT in Aachen and for Applied Optics and Precision Engineering IOF in Jena are developing key technologies for the manufacture of a new generation of microchips using EUV radiation at a wavelength of 6.7 nm. The resulting structures are barely thicker than single atoms, and they make it possible to produce extremely integrated circuits for such items as wearables or mind-controlled prosthetic limbs.

In 1965 Gordon Moore formulated the law that came to be named after him, which states that the complexity of integrated circuits doubles every one to two...

Im Focus: Researchers demonstrate size quantization of Dirac fermions in graphene

Characterization of high-quality material reveals important details relevant to next generation nanoelectronic devices

Quantum mechanics is the field of physics governing the behavior of things on atomic scales, where things work very differently from our everyday world.

Im Focus: Graphene: A quantum of current

When current comes in discrete packages: Viennese scientists unravel the quantum properties of the carbon material graphene

In 2010 the Nobel Prize in physics was awarded for the discovery of the exceptional material graphene, which consists of a single layer of carbon atoms...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

Networking 4.0: International Laser Technology Congress AKL’16 Shows New Ways of Cooperations

24.05.2016 | Event News

Challenges of rural labor markets

20.05.2016 | Event News

International expert meeting “Health Business Connect” in France

19.05.2016 | Event News

 
Latest News

11 million Euros for research into magnetic field sensors for medical diagnostics

27.05.2016 | Awards Funding

Fungi – a promising source of chemical diversity

27.05.2016 | Life Sciences

New Model of T Cell Activation

27.05.2016 | Life Sciences

VideoLinks
B2B-VideoLinks
More VideoLinks >>>