Featured Research

from universities, journals, and other organizations

New antibiotic proven effective to treat acute bacterial skin infections

Date:
June 4, 2014
Source:
Tufts Medical Center
Summary:
The antibiotic dalbavancin is as effective as vancomycin, the current standard-of-care antibiotic used to treat serious bacterial skin and skin-structure infections, research shows. The study results establish dalbavancin as a therapy for Staphylococcus aureus infections, including methicillin-resistant S. aureus, or MRSA.

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.


Story Source:

The above story is based on materials provided by Tufts Medical Center. Note: Materials may be edited for content and length.


Journal Reference:

  1. Helen W. Boucher, Mark Wilcox, George H. Talbot, Sailaja Puttagunta, Anita F. Das, Michael W. Dunne. Once-Weekly Dalbavancin versus Daily Conventional Therapy for Skin Infection. New England Journal of Medicine, 2014; 370 (23): 2169 DOI: 10.1056/NEJMoa1310480

Cite This Page:

Tufts Medical Center. "New antibiotic proven effective to treat acute bacterial skin infections." ScienceDaily. ScienceDaily, 4 June 2014. <www.sciencedaily.com/releases/2014/06/140604203153.htm>.
Tufts Medical Center. (2014, June 4). New antibiotic proven effective to treat acute bacterial skin infections. ScienceDaily. Retrieved September 16, 2014 from www.sciencedaily.com/releases/2014/06/140604203153.htm
Tufts Medical Center. "New antibiotic proven effective to treat acute bacterial skin infections." ScienceDaily. www.sciencedaily.com/releases/2014/06/140604203153.htm (accessed September 16, 2014).

Share This



More Health & Medicine News

Tuesday, September 16, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

President To Send 3,000 Military Personnel To Fight Ebola

President To Send 3,000 Military Personnel To Fight Ebola

Newsy (Sep. 16, 2014) President Obama is expected to send 3,000 troops to West Africa as part of the effort to contain Ebola's spread. Video provided by Newsy
Powered by NewsLook.com
Man Floats for 31 Hours in Gulf Waters

Man Floats for 31 Hours in Gulf Waters

AP (Sep. 16, 2014) A Texas man is lucky to be alive after he and three others floated for more than a day in the Gulf of Mexico when their boat sank during a fishing trip. (Sept. 16) Video provided by AP
Powered by NewsLook.com
EU Ministers and Experts Meet to Discuss Ebola Reponse

EU Ministers and Experts Meet to Discuss Ebola Reponse

AFP (Sep. 15, 2014) The European Commission met on Monday to coordinate aid that the EU can offer to African countries affected by the Ebola outbreak. Duration: 00:58 Video provided by AFP
Powered by NewsLook.com
Despite The Risks, Antibiotics Still Overprescribed For Kids

Despite The Risks, Antibiotics Still Overprescribed For Kids

Newsy (Sep. 15, 2014) A new study finds children are prescribed antibiotics twice as often as is necessary. Video provided by Newsy
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:
from the past week

In Other News

... from NewsDaily.com

Science News

Health News

    Environment News

      Technology News



      Save/Print:
      Share:

      Free Subscriptions


      Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

      Get Social & Mobile


      Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

      Have Feedback?


      Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
      Mobile: iPhone Android Web
      Follow: Facebook Twitter Google+
      Subscribe: RSS Feeds Email Newsletters
      Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins