Drug Resistant Bacteria-Part III of a III Part Article
(5/30/11)- The Food and Drug Administration approved Optimer Pharmaceutical's diarrhea and bowel infection drug Dificid, also known as fidaxoicin, for sale for the treatment of diarrhea caused by Clostridium difficile. Dr. Sherwood I. Gorbach, the company's chief scientific officer was the main developer of the drug.
Dificid is the first new drug approved to treat diarrhea caused by C. difficile in 25 years. For more information on C. difficile please see our item dated 5/27/10 below.
Presently there are two drugs used to treat C. difficile. One is Vancocin, an oral form of the antibiotic vancomycin, which is sold by Viro-Pharma that was approved by the FDA in 1986. The other medication used to treat patients with the affliction is Pfizer's Flagyl, which is also known as metronidazole.
About 1,100 patients were enrolled in the clinical trial of Dificid as compared to Vancocin. Both drugs cleared the diarrhea in more than 85% of patients by the end of the 10-day treatment period, but in the ensuing weeks, about 25% of the Vancocin users had a recurrence of their diarrhea, compared to only about 15% of the Dificid users.
After 25 days of ending the Dificid treatment, about 70% of the Dificid patients were free of their diarrhea versus only 57% of those treated with Vancocin.
The main side effects are nausea, vomiting, abdominal pain and gastrointestinal hemorrhage. Dificid will be taken in tablet form twice a day and will be marketed in conjunction with Cubist Pharmaceuticals. Optimer has not revealed the cost of the medication yet.
(4/21/11)- Two different studies, two different results on the effectiveness of pre-testing patients for drug resistant bacteria before admission to a hospital. The results of both studies were published in a recent edition of The New England Journal of Medicine.
Incidentally, the U.S. Department of Health and Human Services announced that it plans to spend up to $1 billion as part of the health care act that was passed in 2010 to improve patient safety at hospitals aimed at preventing hospital infections and other medical errors.
The first study of 153 Veterans Affairs hospitals nationwide found a 62% drop in the rate of infections caused by methicilin-resistant Staphyloccoccus aureus (MRSA), in intensive care units over a 32-month period, and a 45% drop in MRSA infections when a "bundle" of measures were used to prevent the spread of the bacteria.
The measures included screening of all patients with nasal swabs, isolating those who test positive for MRSA, requiring that staff treating those patients to wear gloves and gowns and take other contact precautions and encouraging rigorous hand washing.
Dr. Rajiv Jain, an official with the Veterans Health Administration was the lead author of this study.
On the other hand, a study lead by Dr. W. Charles Huskins of the Mayo Clinic in Rochester, Minn., that focused on MRSA and vancomycin-resistant enterococcus bacteria, found no significant difference in infection and colonization rates between intensive care units that tested patients as a matter of course and those that did not.
This latter study of 9,000 cases in 2005 and 2006 found that in units that did not conduct universal testing, and where doctors simply ordered screening if symptoms presented, there were similar rates of infection. Doctor Huskins stated that he was surprised by the results of his study.
The Centers for Disease Control and Prevention in Atlanta still estimates that one of every 20 patients will acquire an infection while hospitalized. It concluded that hospital infections were associated with 99,000 deaths and costs of $28 billion to $34 billion a year.
(4/10/11)- British researchers reported in August that infections involving the New Delhi metallobetalactamase NDM-1 had been found in patients in Bangladesh, India, Pakistan and Britain. A team from Cardiff University in Britain made the determination of the finding of this new superbug..
The World Health Organization issued a plea for collective action to fight this new emerging superbug. The British researchers first published their findings in the journal The Lancet Infectious Disease. They determined that NDM-1 had been found in sewage and 2 of 51 tap water samples outside the hospital and in dozens of puddles and pools that children are playing in the city of Delhi, India.
There has not been any reported findingof the bacteria in the U.S.
(9/2/10)- The following is a copy of an email that we recently received concerning the possibility of a drug to fight MRSA. We wish to point out, that as the email states, the drug is entering Phase 2 study and so it still has years to go before the safety and effectiveness of the drug can be proven:
Original Message -----
To: hrubin12@nyc.rr.com
Saturday, August 28, 2010 9:08 AM
"Your article on drug resistant bacteria did not mention a drug developed at the Univ of Penna that is presently entering Phase 2 testing. PMX 30063 has proven to destroy MRSA bacteria within 30 minutes of contact.
PMX-30063 is an antibiotic that mimics natural host defense proteins. Phase 2 studies of this product is planned to commence during 2010. This small molecule protein breaks thru the cell wall thus killing the bacteria with no chance of resistance buildup."
http:://polymedix.com/
Dr Shelly Greene
Many thanks to you Dr. Greene for taking the time to forward this email to us.
(8/13/10)- The results of a study that was published in a recent edition of the journal Lancet Infectious Disease found the presence of a new bacteria called NDM-1 that allowed certain kinds of bacteria to produce a chemical that made antibiotics useless. The initials stand for New Delhi metallo-beta-lactamse.
This new superbug was identified in 3 patients in the U.S. recently, according to the U.S. Centers for Disease Control and Prevention (CDC). All three of the patients had undergone medical treatment in India. A total of 180 patients from India, Pakistan and the U.K. who were treated medically in India were found to have the new superbug.
Although infection from this new bacterium has not proven to be deadly, as is the case with methicilin-resistant Staphylococcus aureus (MRSA), which caused 278,203 hospitalization from 1999 through 2005, medical professionals fear that this may worsen in the coming years.
Health experts have attributed the over usage of antibiotics as the leading cause for the mutations that cause the evolution of superbugs
Bacteria with the NDM-1 gene are resistant even to the antibiotics called carbapenems, which are used as a last resort when other antibiotics have failed.
(5/27/10)- British researchers have warned that the Clostridium difficile bacteria(C difficile), which we discussed in our item dated 11/24/08 below may spread through the air in hospitals, and then land in places that cause the disease to spread if touched.
The bug is commonly spread by contact with infected feces from patients with diarrhea in a hospital. Dr. Mark H. Wilcox, a professor of medical microbiology at the University of Leeds was the senior author for the paper about the study.
Dr. Wilcox emphasized that soap and water is the best preventative from spreading the disease.
(5/21/10)- The incidence of Methicilin-resistant Staphyloccoccus aureus (MRSA) infections among children has increased over ten-fold in the last 10 years according to a study involving 25 children's hospitals. Jason Newland who is an infectious-disease physician at Children's Mercy Hospitals and Clinics and the University of Missouri-Kansas City was the lead author of the study.
The results of the study appeared in a recent edition of the journal Pediatrics.
From 1999k to 2008, MRSA disease incidence rose from two cases per 1,000 hospital admissions to 21 cases per 1,000 hospital admissions. Recent evidence indicates that hospital-acquired MRSA cases may be declining, while community-acquired cases are rising.
Almost 30,000 children were hospitalized with MRSA infections at the hospitals in the 10-year period. Most had skin or muscle infections, with 374 having died from the MRSA infection.
The study found a coinciding rise in the use of the antibiotic clindamycin, but Dr. Newland said that in some regions MRSA is already becoming resistant to the drug.
(4/24/10)- In addition to drug resistant bacteria that occur in hospitals, there are other types of infections that a patient can acquire while under the care of medical professionals while in a hospital.
Under the new health-care law, Medicare payments to hospitals will be reduced for preventable readmission and for certain infections that can be prevented with good nursing care.
The country's hospitals are not doing a good job in this area, according to the Health and Human Services Department's 2009 quality report to Congress. The report found "very little progress" in eliminating hospital-acquired infections and called for "urgent action" in this area.
According to the report:
Rates of bloodstream infections following surgery increased 8%. Urinary infections from the use of a catheter following surgery increased 3.6%. Overall incidence for a series of common infections due to medical care increased by 1.6%.
The number of bloodstream infections due to central venous catheters was unchanged, while the rate of pneumonia following surgery dropped by 12%..
(3/1/10)- In Andrew A. Pollack's article entitled "A Rising Hospital Threat", in the N.Y. Times dated February 27, 2010, he wrote about another drug resistant bacteria, known as Gram-negative bacteria. Methicillin-resistant Staphylococcus aureus (MRSA) is a gram-positive bacteria.
There is a Gram stain test that determines whether a bacterium is deemed negative or positive. Gram-negative bacteria have a double cell membrane, while Gram-positive bacteria have only one cell membrane.
There are no known drugs that have been effective in fighting the Gram- negative baceria, although there are two older antibiotics that were developed in the 1940s that are currently being used in the battle. Those two are colistin and polymyxin B, but they can cause severe kidney and nerve damage.
The Centers for Disease Control and Prevention (CDC) estimates that roughly 1.7 million hospital associated infections, from all types of bacteria combined, cause or contribute to 99,000 deaths each year.
The two most common Gram-negative bacteria are Acinetobacter and Klebsiella pneumoniae. Acinetobacter infections arose in many of the solders who were wounded in Iraq. The bacteria can cause severe pneumonia, and infections of the urinary tract, bloodstream and other parts of the body.
(2/26/09)- The Journal of the American Medical Association recently published the results of a study involving nearly 600 hospitals showed that significant progress is being made in the battle against Methicillin-resistant Staphylococcus aureus (MRSA). We believe that a lot of this improvement has to do with the guidelines that have been emphasized in fighting this disease as shown in our item dated 10/14/08 below.
The government report indicated that the rate in improvement in the decline of ICU unit IV tube-related infections of MRSA has declined by almost 50% between 1997 and 2007.
Now, hopefully, we can see this type of improvement in the battle against Clostridium difficile (C diff) related infections also.
(11/24/08)- A new survey, based on a one-day snapshot taken this year at 648 hospitals in 47 states found that more than 1% of U.S. hospital patients are infected with Clostridium difficile. The Association for Professionals in Infection Control and Epidemiology, a national professional society whose members include doctors, nurses and epidemiologists commissioned the survey.
The survey determined that 13 out of every 1,000 hospitalized patients tested positive for C. diff. The one day snapshot technique is different from methods used in other analyses, so that may explain why its conclusion of the prevalence of the bacterium is greater than other studies have shown it to be.
Use of a bleach solution to clean rooms of infected patients is important in trying to prevent the spread of the disease in the hospital. Proper hand washing is also essential, because the spores aren't always killed by alcohol-based disinfectant gels.
(11/17/08)- The results of a Phase 3 trial which involved only 629 patients in the United States and Canada indicated that there might be another drug that is useful in treating the bacterium Clostridium difficile. The drug was developed by Optimer Pharmaceuticals The company has another Phase 3 study of the drug that it expects to complete next year. If that trial is successful, the company said it would than seek approval from the FDA to market the drug.
The usual treatment for C. difficile infection is the generic antibiotic metronidazole. More serious cases are treated with Vancocin or vancomycin, which is marketed by ViroPharma which is based in Exton, Pa. Virapharma acquired Vancocin from Eli Lilly & Co. in 2004..
In the clinical trail both Optimer's drug OPT-80 and Vancocin were nearly 90% effective in initially clearing the infection. Only 15.4% of those treated with OPT-80 suffered a relapse within four weeks, compared with 25.3% of those treated with Vancocin.
The longer term cure rate without recurrence was 74.6% for OPT-80 compared with 64.1% for Vancocin.
C. difficile infection occurs when patients are treated with antibiotics for other problems. Although this treatment kills many of the other bacterium, it does not kill off the C. difficile bacerium. For more information on the C. difficile bacterium please see our article dated 9/21/08 in Part I of this series of articles.
(10/14/08)- The Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America of America, the Association for Professionals in Infection Control and Epidemiology have joined with the American Hospital Association and the Joint Commission (which accredits hospitals) to issue a compendium of guidelines for preventing six lethal conditions.
These guidelines do not vary significantly from guidelines that have been announced over the last two decades, but the authors said that they had been written more clearly and concisely, with advice not only on what hospitals should do, but also on what they should not do.
Most epidemiologists contend that the problem lies in the fact that health professionals and hospitals had not been adhering to these guidelines. The Leapfrog Group, a combine of various corporations that hope to improve the quality of health care in this country found that 87% of the health-care facilities do not adhere to infection-control guidelines. For more on the Leapfrog Group, please see out item dated 11/22/04 in Part II of this series of articles.
As a prime example of this failure to adhere to the guidelines is the fact that many hospitals do not oversee visitors to intensive care units to make sure that they wash their hands before entering the room.
The federal Centers for Disease Control and Prevention, which also endorses the new guidelines, estimates that there are 7 million infection cases a year in hospitals, and that 99,000 patients die after contracting them (although the infection alone may not be the cause).
Medicare and other health insurers do not pay for the added cost of treating patients who develop certain infections while in a hospital or clinic.
The six conditions covered in the new guidelines are:
Central-line-associated bloodstream infections
Ventilator-associated pneumonia
Catheter-associated urinary tract infections
Surgical site infections
Methicillin-resistant Staphylococcus aureus (MRSA)
Clostridium difficlie, an intestinal bacteria.
Dr. David C. Classen, an epidemologist at the University of Utah, and lead author of the study, said his team surveyed existing recommendations and research before deciding which practices were based on solid science.
The guidelines did include a recommendation that newly admitted patients be tested for MRSA on admission, while accepting the fact that more frequent washing of hands by the employees in medical facilities can do much to prevent the spread of the bacteria.
See also Drug Resistant Bacteria-Part
I
Drug Resistant Bacteria and The Importance
of Cleanliness-Part II
FOR AN INFORMATIVE AND PERSONAL ARTICLE ON PRACTICAL SUGGESTIONS WHEN SELECTING A NURSING HOME SEE OUR ARTICLE "How to Select a Nursing Home"
By Allan Rubin and Harold Rubin, MS, ABD, CRC, Guest Lecturer
updated May 30, 2011
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