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!
Multi-year study finds 'hotspots' of ammonia over world's major agricultural areas
17.03.2017 | University of Maryland
Diabetes Drug May Improve Bone Fat-induced Defects of Fracture Healing
17.03.2017 | Deutsches Institut für Ernährungsforschung Potsdam-Rehbrücke
Astronomers from Bonn and Tautenburg in Thuringia (Germany) used the 100-m radio telescope at Effelsberg to observe several galaxy clusters. At the edges of these large accumulations of dark matter, stellar systems (galaxies), hot gas, and charged particles, they found magnetic fields that are exceptionally ordered over distances of many million light years. This makes them the most extended magnetic fields in the universe known so far.
The results will be published on March 22 in the journal „Astronomy & Astrophysics“.
Galaxy clusters are the largest gravitationally bound structures in the universe. With a typical extent of about 10 million light years, i.e. 100 times the...
Researchers at the Goethe University Frankfurt, together with partners from the University of Tübingen in Germany and Queen Mary University as well as Francis Crick Institute from London (UK) have developed a novel technology to decipher the secret ubiquitin code.
Ubiquitin is a small protein that can be linked to other cellular proteins, thereby controlling and modulating their functions. The attachment occurs in many...
In the eternal search for next generation high-efficiency solar cells and LEDs, scientists at Los Alamos National Laboratory and their partners are creating...
Silicon nanosheets are thin, two-dimensional layers with exceptional optoelectronic properties very similar to those of graphene. Albeit, the nanosheets are less stable. Now researchers at the Technical University of Munich (TUM) have, for the first time ever, produced a composite material combining silicon nanosheets and a polymer that is both UV-resistant and easy to process. This brings the scientists a significant step closer to industrial applications like flexible displays and photosensors.
Silicon nanosheets are thin, two-dimensional layers with exceptional optoelectronic properties very similar to those of graphene. Albeit, the nanosheets are...
Enzymes behave differently in a test tube compared with the molecular scrum of a living cell. Chemists from the University of Basel have now been able to simulate these confined natural conditions in artificial vesicles for the first time. As reported in the academic journal Small, the results are offering better insight into the development of nanoreactors and artificial organelles.
Enzymes behave differently in a test tube compared with the molecular scrum of a living cell. Chemists from the University of Basel have now been able to...
20.03.2017 | Event News
14.03.2017 | Event News
07.03.2017 | Event News
24.03.2017 | Materials Sciences
24.03.2017 | Physics and Astronomy
24.03.2017 | Physics and Astronomy