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 Research investigates whether solar events could trigger birth defects on Earth
21.07.2015 | University of Kansas

nachricht Accounting for short-lived forcers in carbon budgets
15.07.2015 | International Institute for Applied Systems Analysis (IIASA)

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: Quantum Matter Stuck in Unrest

Using ultracold atoms trapped in light crystals, scientists from the MPQ, LMU, and the Weizmann Institute observe a novel state of matter that never thermalizes.

What happens if one mixes cold and hot water? After some initial dynamics, one is left with lukewarm water—the system has thermalized to a new thermal...

Im Focus: On the crest of the wave: Electronics on a time scale shorter than a cycle of light

Physicists from Regensburg and Marburg, Germany have succeeded in taking a slow-motion movie of speeding electrons in a solid driven by a strong light wave. In the process, they have unraveled a novel quantum phenomenon, which will be reported in the forthcoming edition of Nature.

The advent of ever faster electronics featuring clock rates up to the multiple-gigahertz range has revolutionized our day-to-day life. Researchers and...

Im Focus: Superfast fluorescence sets new speed record

Plasmonic device has speed and efficiency to serve optical computers

Researchers have developed an ultrafast light-emitting device that can flip on and off 90 billion times a second and could form the basis of optical computing.

Im Focus: Unlocking the rice immune system

Joint BioEnergy Institute study identifies bacterial protein that is key to protecting rice against bacterial blight

A bacterial signal that when recognized by rice plants enables the plants to resist a devastating blight disease has been identified by a multi-national team...

Im Focus: Smarter window materials can control light and energy

Researchers in the Cockrell School of Engineering at The University of Texas at Austin are one step closer to delivering smart windows with a new level of energy efficiency, engineering materials that allow windows to reveal light without transferring heat and, conversely, to block light while allowing heat transmission, as described in two new research papers.

By allowing indoor occupants to more precisely control the energy and sunlight passing through a window, the new materials could significantly reduce costs for...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

3rd Euro Bio-inspired - International Conference and Exhibition on Bio-inspired Materials

23.07.2015 | Event News

Clash of Realities – International Conference on the Art, Technology and Theory of Digital Games

10.07.2015 | Event News

World Conference on Regenerative Medicine in Leipzig: Last chance to submit abstracts until 2 July

25.06.2015 | Event News

 
Latest News

California 'rain debt' equal to average full year of precipitation

31.07.2015 | Physics and Astronomy

Telescopes team up to find distant Uranus-sized planet through microlensing

31.07.2015 | Physics and Astronomy

Quantum Matter Stuck in Unrest

31.07.2015 | Physics and Astronomy

VideoLinks
B2B-VideoLinks
More VideoLinks >>>