FDA Approves Teflaro for Bacterial Infections

The U.S. Food and Drug Administration today (October 29) approved Teflaro (ceftaroline fosamil), an injectable antibiotic to treat adults with community acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI), including methicillin-resistant Staphylococcus aureus (MRSA).

Teflaro is an antibacterial agent in a class of drugs known as cephalosporins, which act by interfering with the bacterial cell wall.

CABP is a bacterial infection that develops in the lungs of patients who are exposed to the bacteria in their normal environment, and not in the hospital. ABSSSI is a bacterial infection of skin and skin structures that requires antibiotic treatment and may require surgical treatment.

MRSA is a type of staph bacteria that is resistant to certain antibiotics. These antibiotics include methicillin and other more common antibiotics such as oxacillin, penicillin, and amoxicillin. In the community, most MRSA infections are skin infections. Severe or potentially life-threatening MRSA infections occur most frequently among patients in contact with health care settings, according to the Centers for Disease Control and Prevention.

“These are serious and potentially life-threatening infections for which new treatment options are needed,” said Edward Cox, M.D., M.P.H, director, Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research. “FDA is committed to facilitating new antibiotic drug development.”

The safety and effectiveness of Teflaro was evaluated in four, Phase 3 clinical trials in patients ages 18 years and older (two each in CABP and in ABSSSI). In the CABP trials, the comparator antibacterial treatment was Rocephin (ceftriaxone) and in the ABSSSI trials, the comparator antibacterial treatment was Vancocin (vancomycin) plus Azactam (aztreonam).

In the CABP trials, 1,231 adult patients received Teflaro or Rocephin. Clinical response based on improvement in signs and symptoms of pneumonia on Day 4 after starting therapy served as the key analysis endpoint. In both trials, the effectiveness of Teflaro was comparable to Rocephin.

In the ABSSSI trials, 1,396 adult patients received Teflaro or Vancocin plus Azactam. Clinical response, including cessation of spread of the lesion and absence of fever on Day 3, served as the key analysis endpoint. In both trials, Teflaro was comparable to Vancocin plus Azactam.

The most commonly reported side effects in patients treated with Teflaro included diarrhea, nausea and rash. Teflaro should not be used in patients with sensitivities to cephalosporin antibiotics.

Teflaro is marketed by New York City-based Forest Laboratories.

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Online Course Gives Physicians Useful Info about Community-Associated MRSA

A new bacterial infection is running rampant in communities because of antibiotic abuse, but ironically it is often misdiagnosed and treated with the wrong antibiotics, says a physician working to stop it.

Physicians regularly mistake the abscesses, or pockets of pus, caused by community-associated MRSA, or CA-MRSA, for spider bites and treat them as such, say Dr. Jim Wilde, pediatric emergency medicine and infectious disease physician at the Medical College of Georgia.

"Don't be fooled into thinking it's a spider bite," he says. "Think MRSA if you see a sore like that on somebody's hand or arm. The problem is that doctors are choosing the wrong oral antibiotics or are just not recognizing it at all."

Now they can log on to a new online lecture through the MCG Division of Continuing Education to learn more about this leading cause of skin and soft-tissue infections in the state.

It's part of a statewide educational campaign sponsored by Georgia United against Antibiotic Resistant Disease, or GUARD, to raise awareness about CA-MRSA.

Doctors and the general public can access the lecture at www.mcg.edu/ce/Online/mrsaonline. Physicians can receive continuing medical education credits for participating.

"The lecture, which is the first online continuing medical education course at MCG, is an excellent opportunity to learn more about this epidemic," says Caro Cassels, director of the continuing education division.

"There is a lot of misinformation and misunderstanding about MRSA, even among practicing physicians," says Dr. Wilde, who directs GUARD. "And we see dozens of cases of CA-MRSA in the emergency room every week here. It is a different type of MRSA than what we've known for the last 40 years and is spreading all over the country very rapidly."

MRSA, or methicillin resistant Staph aureus, cannot be killed by methicillin, a type of penicillin. It is spread by physical contact, not by breathing the same air or coughing. It lives on the skin and can survive on others surfaces for at least 24 hours. Hospital-associated MRSA (HA-MRSA) has been rampant inside hospitals since the early 1960s but was rare among healthy people in the community. CA-MRSA popped up around 2003 and quickly spread nationwide, causing infections primarily in healthy people outside hospitals. Infections caused by either form of MRSA can be treated, but HA-MRSA is much more dangerous. Both are resistant to all beta-lactam antibiotics, which are the most widely used class of antibiotics available.

"And yet, despite the fact that most skin and soft-tissue infections now are caused by CA-MRSA, there are still many doctors who are prescribing these antibiotics," Dr. Wilde says. "We're trying to do is get the word out to everyone in the state to stop using beta-lactams for skin infections."

In addition to the online course, 9,700 primary care physicians received educational packets from GUARD. Each packet contains a CA-MRSA fact sheet, an informational poster, a two-page synopsis of Centers for Disease Control and Prevention recommendations for treating CA-MRSA and a fill-in-the-blank discharge sheet. Dr. Wilde also coordinates a speakers' bureau on CA-MRSA with more than 30 members available to deliver lectures anywhere in the state.

GUARD is the Georgia chapter of the CDC's Get Smart about Antibiotic Use Program. The coalition seeks to reduce antibiotic-resistant disease by decreasing inappropriate antibiotic use. The educational campaign also is sponsored by the Georgia Department of Human Resources.

For more information about the online course and coalition, visit www.ga-guard.org.

By Amy Connell
Medical College of Georgia

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Studies Highlight MRSA Evolution and Resilience

Community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA) infections are caused primarily by a single strain — USA300 — of an evolving bacterium that has spread with "extraordinary transmissibility" throughout the United States during the past five years, according to a new study led by National Institutes of Health (NIH) scientists. CA-MRSA, an emerging public health concern, typically causes readily treatable soft-tissue infections such as boils, but also can lead to life-threatening conditions that are difficult to treat.

The study, from the National Institute of Allergy and Infectious Diseases (NIAID) of NIH, resolves debate about the molecular evolution of CA-MRSA in the United States. The findings rule out the previously held possibility that multiple strains of USA300, the most troublesome type of CA-MRSA in the United States, emerged randomly with similar characteristics. The study also offers a hypothesis for the origin of previous S. aureus outbreaks, such as those caused by penicillin-resistant strains in the 1950s and 1960s.

A second study led by the same NIAID scientists takes the issue of the evolution of MRSA a step further, revealing new information about how MRSA bacteria in general, including the USA300 group, elude the human immune system.

The first study, which appears online this week in the Proceedings of the National Academy of Sciences, found that the USA300 group of CA-MRSA strains, collectively called the epidemic strain, comprises nearly identical clones that have emerged from a single bacterial strain. It is the first time scientists have used comparative genome sequencing to reveal the origins of epidemic CA-MRSA. Frank R. DeLeo, Ph.D., at NIAID's Rocky Mountain Laboratories (RML) in Hamilton, Mont., led the research.

"Scientists are pressing ahead quickly to learn more about how some MRSA strains evade the immune system and spread rapidly," says NIAID Director Anthony S. Fauci, M.D. "The information presented in these two studies adds important new insights to that expanding knowledge base."

To understand how CA-MRSA is evolving in complexity and spreading geographically, Dr. DeLeo's group sequenced the genomes of 10 patient samples of the USA300 bacterium recovered from individuals treated at different U.S. locations between 2002 and 2005. They then compared these genomes to each other and to a baseline USA300 strain used in earlier studies. Eight of the 10 USA300 patient samples were found to have nearly indistinguishable genomes, indicating they originated from a common strain. The remaining two bacteria were related to the other eight, but more distantly.

Interestingly, of the eight nearly indistinguishable USA300 patient samples, two caused far fewer deaths in laboratory mice than the others, highlighting an emerging view that tiny genetic changes among evolving strains can profoundly affect disease severity and the potential for drug resistance to develop.

"The USA300 group of strains appears to have extraordinary transmissibility and fitness," says Dr. DeLeo. "We anticipate that new USA300 derivatives will emerge within the next several years and that these strains will have a wide range of disease-causing potential." Ultimately, Dr. DeLeo and his colleagues hope that the work will lead to the development of new diagnostic tests that can quickly identify specific strains of MRSA.

Fred C. Tenover, Ph.D., of the Centers for Disease Control and Prevention in Atlanta (CDC) contributed the 10 USA300 clinical isolates from CDC's Active Bacterial Core Surveillance system. Other study collaborators included Barry N. Kreiswirth, Ph.D., of the International Center for Public Health (ICPH) in Newark, N.J., and James M. Musser, M.D., Ph.D., of The Methodist Hospital Research Institute in Houston.

The second report, which involved scientists from RML, ICPH and Vanderbilt University Medical Center in Nashville, was recently published online in the Journal of Immunology. This study provides scientists with new details about the complex mechanisms MRSA uses to avoid destruction by neutrophils, human white blood cells that ingest and destroy microbes. When exposed to hydrogen peroxide, hypochlorous acid (the active component of household bleach) or antimicrobial proteins — all killer chemicals released by neutrophils — MRSA senses danger, escapes harm and turns the tables on the white blood cells, destroying them. Work is continuing in Dr. DeLeo's lab to understand how the bacterium senses and survives attacks by neutrophils.

NIAID is a component of the National Institutes of Health. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on basic immunology, transplantation and immune-related disorders, including autoimmune diseases, asthma and allergies.