New GERD Device Offered At Mayo Clinic
A new device to treat gastroesophageal reflux disease (GERD), a condition that can lead to serious health problems, will soon be available at the Mayo Clinic in Florida. The device will be offered to patients taking medication for the condition, who continue to have chronic reflux symptoms. The device was approved to treat GERD (also known as acid reflux disease) on March 22 by the U.S., Food and Drug Administration (FDA). The Mayo Clinic in Florida will be one of the first health care institutions in the nation to offer the device. C. Daniel Smith, M.D., chair of the Surgery Department at Mayo Clinic in Florida, an expert on the treatment of GERD who is experienced in using the device, reveals that the clinic expects to offer the device immediately. The clinic was 1 of only 14 centers nationwide to take part in a clinical human trial that resulted in device's approval. Dr. Smith explained:

"Mayo has been a leader in the treatment of esophageal diseases, especially GERD, and we are pleased to be offering this new treatment to our patients immediately."

Although medications to prevent GERD by neutralizing the acid in the stomach are available, if they fail to work, an operation to correct the mechanical defect is considered. According to Dr. Smith, around 1.5 - 2 million of those patients could benefit from significantly less complex treatment than current surgical options. Dr. Smith, said:

"The new system will offer a long-needed treatment option for a large group of underserved patients."

Although results from the trial that resulted in the approval of the device have not been published, Dr. Smith explains that "the data presented to the FDA revealed striking results when compared to other GERD treatments that have been investigated over the past 20 years. The system offers effective control of GERD with limited side effects and thus far an excellent safety record." The device, which serves as a mechanical augmentation of the lower esophageal sphincter, is a ring of tiny magnetic titanium beads wrapped around the junction between the stomach and esophagus. Although the magnetic attraction between the beads is powerful enough to prevent acid reflux, the attraction is weak enough to allow food to enter into the stomach. Dr. Smith notes that the device can be implanted using minimally invasive surgery methods. Over the past several decades, Dr. Smith has been involved with several new treatments and performs approximately 200 GERD-related surgeries per year. Dr. Smith said:

"I expect this device to be a game changer for the treatment of GERD in select patients who have failed management with drugs."

Ken DeVault, M.D., chair of the Department of Internal Medicine at Mayo Clinic in Florida, who took part in these studies, said:

"I have many patients who are searching for something more than medication for their reflux, but have been hesitant to undergo traditional reflux surgery. I think this procedure may well be a very attractive option for that group."

Salmonella Bareilly Infection Outbreak In 19 States
With at least 100 reported infections with Salmonella Bareilly, US authorities say 19 states and the District of Columbia have been affected so far. According to an FDA memo, the current salmonellosis outbreak is spreading rapidly. The CDC (Centers for Disease Control and Prevention) informs that experts do not yet know what the source of the infection is, and also that no deaths have been reported. Health authorities added that it is definitely a food source. Ten people have been hospitalized because of the outbreak. As of the end of Friday, April 6th, the number of reported human infections per state are as follows:

• New York 23
• Maryland 10
• Illinois 9
• Wisconsin 9
• New Jersey 7
• Connecticut 5
• Virginia 5
• Georgia 4
• Massachusetts 4
• Rhode Island 4
• Pennsylvania 3
• South Carolina 3
• Texas 3
• Alabama 2
• District of Columbia 2
• Louisiana 2
• North Carolina 2
• Arkansas 1
• Mississippi 1
• Missouri 1

The CDC says it is liaising closely with local health authorities in each state and is carrying out its own investigation into individual food items and their sources. Both the CDC and FDA say they will announce any updates the moment they are available. According to the FDA, there is an approximately 30 day lag between onset of sickness and health officials receiving news. Salmonella Bareilly is one of the rarer subspecies of Salmonella bacteria.

Signs and symptoms of Salmonella Infection
Rather than caused by any direct toxin produced by the bacterium, it is the human's response to the bacterium which typically triggers symptoms. A symptom is something the patient feels and describes, such as abdominal pain, while a sign is something everybody is capable of detecting, such as a rash. The signs and symptoms of salmonellosis (Salmonella infection) include:

• Abominal cramps (stomachache)
• Nausea
• Vomiting
• Diarrhea (may be bloody and with mucus)
• Headache
• Tiredness
• Rose spots

Very young children and elderly individuals, as well as those with weak immune systems, have a higher risk of more severe symptoms. Typically, symptoms last up to 7 days. After becoming infected, signs and symptoms, if they do appear, will usually do so after 12 to 72 hours.

Staph Infections Rapidly Detected By New Laboratory Method Using Mass Spectrometry
Researchers from the Georgia Institute of Technology and the Centers for Disease Control and Prevention (CDC) have developed a new laboratory test that can rapidly identify the bacterium responsible for staph infections. This new test takes advantage of unique isotopic labeling combined with specific bacteriophage amplification to rapidly identify Staphylococcus aureus. The test uses mass spectrometry to quantify the number of S. aureus organisms in a large number of samples in just a few hours, compared to a day or two for culturing techniques typically used to detect this bacterium. Details of the new staph infection detection method were published in the January issue of the journal Molecular and Cellular Proteomics.

CDC Fears Rising Treatment Resistant Gonorrhea
Gonorrhea may be losing its susceptibility to cephalosporins, the only available antibiotic class remaining to treat the sexually transmitted infection, the CDC is warning. Surveillance data over an 11-year period show that the proportion of Neisseria gonorrhoeae isolates with an elevated minimum inhibitory concentration (MIC) against one of the cephalosporins has risen significantly. The drugs commonly used to treat gonorrhea – cefixime (Suprax) and ceftriaxone (Rocephin) – remain effective, the agency said, but physicians should be vigilant for treatment failure. "We have not yet seen any documented treatment failures in the United States," said Gail Bolan, MD, director of the agency's Division of STD Prevention. "But what we have learned in the past is that we have to take these MIC trends very seriously," Bolan said. In the past, Bolan added, the CDC responded to resistance by suggesting doctors switch antibiotics. "We are now at impasse, as we have no new drugs to switch to," she said. Resistance to penicillin and tetracycline became widespread during the early 1980s, and more recently, resistance to fluoroquinolones has developed, leading the CDC in 2007 to stop recommending fluoroquinolone regimens to treat the infection. What's worrying the CDC is that, in the case of the fluoroquinolones, rising MICs were first seen in Asia, followed by the west of the U.S., and then the rest of the country. Frank resistance followed, Bolan noted. The pattern is similar, so far, with the cephalosporins, she said. The MIC for cefixime is at least 0.25 micrograms per milliliter and for ceftriaxone is at least 0.125 microgram per milliliter, but Bolan noted that's a lab value. "We don't yet know, for the cephalosporins, what is technically a resistance level MIC," she said. Nonetheless, the changing susceptibility pattern in the lab is alarming, she said -- and it appears to be mirroring what happened with the fluoroquinolones. In 2000, the CDC's Gonococcal Isolate Surveillance Project found that just 0.2% of 5,461 tested isolates had an elevated MIC against cefixime and 0.1% had lessened susceptibility to ceftriaxone. By 2010, those proportions, in 5,693 tested isolates, had grown to 1.4% for cefixime and 0.3% for ceftriaxone, the agency reported. The changes were significant at P<0.001 and P=0.047, respectively. Most of the increased susceptibility occurred in the western region of the U.S., where the percentage of isolates with lessened susceptibility to cefixime increased from 0% to 3.3% over the study period while the percentage with an elevated MIC to ceftriaxone rose 0% to 0.5%. Both differences were significant at P<0.001. When resistance was developing to the fluoroquinolones, rising MICs were mainly seen among men who have sex with men -- another facet of the pattern that's mirrored in the current situation. Overall, men who have sex with men were most likely to have gonorrhea with lessened susceptibility to one of the two cephalosporins, the agency reported. For cefixime, the percentage of isolates with an elevated MIC rose from 0% in 2000 to 4.0% during 2010, and for ceftriaxone the rate went from 0% to 0.9%. Again, both differences were significant at P<0.001. Overall, there were no significant changes in isolates from men who have sex exclusively with women, the CDC reported, although regionally those from the west showed a significant increase in elevated MICs. Currently, the CDC recommends treating uncomplicated gonorrhea with 250 milligrams of ceftriaxone, delivered intramuscularly, with one gram of either azithromycin (Zithromax) or doxycycline (various brands), given orally. Azithromycin is preferred over doxycycline for dual therapy with ceftriaxone. That recommendation hasn't changed, but the CDC wants doctors also to keep a watchful eye out for possible treatment failures and to report them promptly. One change, Bolan said, is that in cases of possible treatment failure, doctors should obtain samples for culture, rather than for nucleic acid-based testing, which looks for the DNA of N. gonorrhoeae in a urine sample, for instance. But it's not possible to tell if a sample is resistant from those tests, Boland said, so old-fashioned cultures are needed. Local and state health authorities can help by ensuring that sufficient labs have a gonococcal culture capability, Bolan added. She said the CDC is also hoping that alarm bells will ring in the pharmaceutical industry, leading to the development of new antibiotics. The agency cautioned that the isolates tested for this study came from men who attended publicly funded STD clinics and therefore represent a subset of men with the infection.

Salmonella Outbreak Linked To Ducklings or Chicks
Eight cases of salmonellosis have triggered an investigation by Ohio state officials who have linked them to ducklings and/or chicks sourced from an Ohio hatchery and bought at various agricultural outlets across the state. Health authorities are advising Ohioans to handle chicks and ducklings with care. The eight infected people live in Licking, Ashtabula, Jefferson, Columbiana, Hamilton, Franklin, Medina and Wood counties. They range from 3 months to 76 years of age. Salmonella Altona was detected in one of the chicks that belonged to one of the infected people. The Ohio Departments of Health and Agriculture say they are liaising closely with the CDC (Centers for Disease Control and Prevention), and the USDA National Poultry Improvement Plant in response to the outbreak. In most of the cases of salmonella infection, the patients said they had been exposed to ducklings and/or chicks bought at different agricultural outlets of a national agricultural feed store that had sourced the baby birds from Mt. Healthy Hatchery, Ohio. The Ohio Department of Health says the hatchery, as well as the outlets have been working closely with federal and state officials during this investigation. Officials warn that other companies may also have received infected ducklings and chicks. According to the CDC, there have been 30 salmonella outbreaks linked to chicks and duckling since the 1990s.

Novel Gene Causes MRSA That Tests Miss
Two research groups have independently found a novel form of methicillin-resistant Staphylococcus aureus (MRSA) that is not detected by some standard tests. The new strain is able to grow in the presence of antibiotics used to test for MRSA, but has a resistance gene that is sufficiently unusual that it does not register on genetic tests, which are widely used to confirm antibiotic tests.

The finding is ringing alarm bells because of the possibility that diagnosis of disease caused by the resistant bacteria may be incorrect, leading to inappropriate treatment, according to Mark Holmes, VetMB, of the University of Cambridge, who led one of the research teams. In such a case, "the tests we use at the moment to confirm MRSA status will be falsely negative."

The novel strain has been detected in both cattle and people, suggesting that - although S. aureus is usually species-specific - animals might be a reservoir for new strains that could jump to humans. Methicillin resistance in S. aureus depends on a gene called mecA, which is part of a DNA cassette than can jump from strain to strain, spreading the resistance. Holmes and colleagues were studying S. aureus in cattle, and found an isolate that grew in the presence of oxacillin (Bactocill) and cefoxitin (Mefoxin), the antibiotics usually used to test for MRSA. But, they reported online in The Lancet Infectious Diseases, genetic testing using polymerase chain reaction did not detect the gene and a slide agglutination test did not detect the penicillin binding protein, PBP2a, made by mecA.

Meanwhile, in Ireland, researchers led by David Coleman, PhD, of the University of Dublin, had found two S. aureus isolates from humans that were methicillin-resistant but – as in the English study – did not appear to have a mecA gene. On the other hand, they reported online in Antimicrobial Agents and Chemotherapy, some of the available protein tests did show the presence of the penicillin binding protein PBP2a.

In both cases, however, whole genome analysis showed that the resistant bacteria did have a mecA gene – it was just about 60% different from the gene that can be found using genetic methods. Only 12 of the 25 base pairs of the new gene, dubbed mecA _LGA251, are the same as those in the more common gene used in PCR testing.

The two research teams became aware of each other's work as their respective papers were in the process of publication. The genes found by the two groups are almost identical, Coleman and colleagues reported. After their initial discovery, Holmes and colleagues asked whether the new mecA gene existed in MRSA strains from humans. To find out, they culled stored samples of mecA-negative resistant strains from England, Scotland, and Denmark and found that mecA _LGA251 was present in 12 of 16 isolates from Scotland, 15 of 26 from England, and 24 of 32 from Denmark.

Interestingly, Holmes and colleagues found that variations within the novel strain tended to cluster geographically, with both humans and cattle in the same region having similar strains. That finding suggests that there has been transmission between species, although it's not clear which way the resistance gene has been moving, the researchers said. But there is precedent for MRSA to move from animals to people – so-called "livestock-associated MRSA" has been found both in pigs and the people that tend them, Holmes and colleagues noted. That strain has been shown to cause infection in humans, they reported.

The novel strain may also have been responsible for some disease; at least some of the isolates they tested, came from patients with MRSA infections, including bacteremia, rather than simple colonization. The two studies "indicate that new types of MRSA that can colonize and infect humans are currently emerging from animal reservoirs in Ireland and Europe and it is difficult to correctly identify them as MRSA," Coleman said in a statement.

The knowledge will allow genetic MRSA tests to be adapted, Coleman said, but it "has also provided invaluable insights into the evolution and origins of MRSA." Evidence from Denmark, where all MRSA isolates are archived, suggests that the prevalence of the novel strain is increasing, although absolute numbers remain small. There's not yet enough data over time to be sure of the shape of the curve; it might keep rising or it might peak and fall back. Holmes said there should be no fear of milk or milk products as long as they are pasteurized, since that process kills all bacteria. The risk of disease associated with unpasteurized milk and cheese remains minimal, he added.

FDA Clears Fast MRSA Test
The FDA has cleared the first test that quickly distinguishes between methicillin resistant (MRSSA) or methicillin susceptible (MSSA) Staphylococcus aureus (S. aureus) bacteria. The KeyPath MRSA/MSSA Blood Culture Test determines if the bacteria is resistant or susceptible to antibiotics in a positive blood culture sample within about five hours after the growth is first detected, according to an FDA statement. The test, manufactured by MicroPhage, does not require specific instruments beyond blood culture equipment, according to the statement.


Hand Cleaners Don't Protect Against MRSA; FDA Warns Makers
Four companies have been sent letters by the FDA warning against inaccurate claims stating that their products stave off infection from methicillin-resistant Staphylococcus aureus bacteria (MRSA). Statistical data suggest that as many as 19,000 people per year die from MRSA in the U.S. but the most current data suggest this number has declined by about 25% to 35% in recent years, in part, because of prevention practices at hospitals and home care alone. MRSA was first noted in 1961, about two years after the antibiotic methicillin was initially used to treat S. aureus and other infectious bacteria. The resistance to methicillin was due to a penicillin-binding protein coded for by a mobile genetic element termed the methicillin-resistant gene (mecA). In recent years, the gene has continued to evolve so that many MRSA strains are currently resistant to several different antibiotics such as penicillin, oxacillin, and amoxicillin. Infections may start on the skin, then develop into deep, painful abscesses; the bacteria may also move into the bloodstream, causing potentially life-threatening infections. MRSA often circulates in hospitals, nursing homes and other health-care settings, but has been found to spread in the community, particularly in school locker rooms and child-care facilities. Lotion based hand sanitizers work in the same manner as gel-based hand sanitizers but come in a thicker, more moisturizing formula. Like other sanitizers, however, it's important to look at the ingredients. Several of these popular formulas do not contain alcohol, which is the most effective ingredient for killing germs. Labeling and marketing materials for the affected products also claim that they can prevent infection from other disease-causing agents. In addition, the labeling of some of the firms' hand sanitizing drug products make claims related to preventing infection from E.coli and/or H1N1 flu virus. The FDA does not have sufficient evidence demonstrating that these products are safe and effective for these purposes.

What brands and products should you look out for? Here's the list the FDA mentions in a news release:

• Tec Laboratories for Staphaseptic First Aid Antiseptic/Pain Relieving Gel
• JD Nelson and Associates for Safe4Hours Hand Sanitizing Lotion and Safe4Hours First Aid Antiseptic Skin Protectant
• Dr. G.H. Tichenor Antiseptic Co. for Dr. Tichenor's Antiseptic Gel
• Oh So Clean, Inc dba CleanWell Company for CleanWell All-Natural Foaming Hand Sanitizer, CleanWell All-Natural Hand Sanitizer, CleanWell All-Natural Hand Sanitizing Wipes, and CleanWell All-Natural Antibacterial Foaming Handsoap

Wound Care May Be More Important Than Antibiotics For Preventing Infection
Preventing infection in a wound may depend less on choosing the right antibiotic than on simply keeping it clean, according to a study published in the March issue of Pediatrics. Researchers randomized 200 youngsters ranging in age from six months to 18 years, each of whom had a skin infection and 137 of which tested positive for MRSA, to either clindamycin, an antibiotic that is effective against MRSA, or cephalexin, one that is less active against it. The study authors found that the choice of antibiotic made no difference. More important was taking good care of the wound, keeping it clean, and following the patient closely.

The AAUCM recommends the Clinical Practice Guidelines by the Infectious Diseases Society of America for the Treatment of Methicillin-Resistant Staphylococcus Aureus Infections in Adults and Children.

Guideline on MRSA Treatment
Clinicians treating methicillin-resistant Staphylococcus aureus (MRSA) infections may now refer to an authoritative practice guideline issued by the Infectious Diseases Society of America. The guideline, published online in Clinical Infectious Diseases, addresses management of various types of infection, use of vancomycin and adjunctive therapies, and special situations including vancomycin failure and MRSA infections in newborns. The guideline notes that MRSA has been a growing problem for 50 years, with nearly 100,000 invasive infections reported in the U.S. in 2005. Although infections were contracted almost exclusively in healthcare facilities into the 1990s, community-acquired strains have become prominent since then. Although these two types of MRSA had important differences in genetics and responses to existing antibiotics, they have since intermingled enough that the distinction has become difficult to maintain. The guideline indicates that incision and drainage would probably be sufficient for minor SSTIs such as superficial abscesses and boils. Empirical treatment of more serious SSTIs in outpatients should start with clindamycin, trimethoprim-plus-sulfamethoxazole, a tetracycline, or linezolid. Other regimens, including IV antibiotics, should be considered for hospitalized patients with complicated SSTIs, according to the guideline. These could include vancomycin, daptomycin, telavancin, or beta-lactam agents depending on the clinical presentation. IV vancomycin or daptomycin should also be first-line therapy for bacteremia and infective endocarditis. For MRSA pneumonia, the guideline calls for vancomycin, linezolid, or clindamycin. The guideline also emphasizes the importance of addressing the source of infection with drainage and surgical debridement whenever possible. For recurrent infections, it recommends strict hygiene practices in patients' environment, including nasal and topical decolonization.

Deadly Fungus Spreads Across Pacific Northwest
A deadly fungal infection that surprised researchers by popping up in a non-tropical climate is spreading across the Pacific Northwest. Cryptococcus gattii was first identified on Vancouver Island, then in British Columbia -- and has now emerged in the U.S. as well. Researchers reported 263 C. gattii infections since 1999 in British Columbia and 70 infections in the U.S. since 2004. "C. gattii is an emerging and serious infection in the Pacific Northwest," said Julie Harris, PhD, MPH, a staff epidemiologist at the CDC who discussed the fungal disease during a press briefing Human infections with C. gattii were first reported on Vancouver Island. Since being reported in the U.S., infections with C. gattii have been found in Washington, Oregon, Idaho and California. Since its first emergence in British Columbia about 24 cases of C. gattii infections are reported each year. About 9% of patients infected with the fungus have died, said Eleni Galanis, MD, MPH, a physician-epidemiologist at the British Columbia Centre for Disease Control in Vancouver. In the U.S., the CDC's Harris said the fatality rate for C. gattii cases is about 32%. She said doctors are not sure why the fatality rate is higher in the U.S. compared with Canada, but underlying conditions of the infected patients may play a role in the higher U.S. death rate. While non-tropical C. gattii exposure appears to be limited to the Pacific Northwest, the fungus shows up throughout the environment in the affected area. C. gattii is believed to prefer rotting wood or hollow of trees. "This study emphasized the importance of physicians taking a travel history when evaluating their patients," said James Hughes, MD, professor of medicine and public health at Emory University, Atlanta. Galanis said that C. gattii was believed to be endemic to tropical areas, affecting only sub-tropical parts of Australia and South America, until it appeared in patients in British Columbia. "The reasons why it emerged and where it came from are still unclear," she said. "People get infected by breathing in the fungus and usually get an infection in the lungs, presenting as pneumonia or lung nodules," Galanis explained. "Symptoms include cough, shortness of breath and fever. The infection can spread beyond the lungs and enter the central nervous system or the brain where it can cause meningitis and these patients present with headache and fever," she added. "A large percentage -- 40% of those infected -- are immunocompromised by either HIV infection, cancer, organ transplant, or have been on corticosteroid therapy. People also at risk of C. gattii infection include people over the age of 50, people with chronic lung diseases and people who smoke," she said. Harris said that most of the 70 infections in the U.S have occurred in Washington and Oregon. "The number of infections in the United States is still increasing," she said. Cases have also been found in Idaho, California, Alaska, Hawaii and Arizona. Harris said the Alaska and Idaho cases are likely travel-associated. "Treatment for C. gattii is lengthy, lasting six to 18 months and involves use of amphotericin and fluconazole." "About one-third of the patients develop fungal masses in the lungs or brain which can make the disease more difficult to treat. About 90% of the patients have been hospitalized for their infections. Having an underlying medical problem appears to be a risk factor. Although 75% of the patients have an underlying health problem, 25% of the infected patients were healthy before encountering the fungus, Harris said. "The patients who were previously healthy appear to have a more serious disease than those who had an underlying disease when infected. It should be noted that these infections are still rare," she added.

FDA OKs Test for Swift HIV Diagnosis
The FDA has approved an HIV diagnostic test that can detect the virus within days of infection. The ARCHITECT HIV Ag/Ab Combo assay, developed by Abbott Labs, detects both HIV antibodies and an antigen from the virus itself. It's the first such test licensed in the U.S. The test has been used in Europe since 2004 and should be available in the U.S. by the end of the year.