Category Archives: U.S. Government Announcements

Clostridium difficile (C.diff.) Infection (CDI) Rates In the United States and Across the Globe Have Increased In the Last Decade, Along With Associated Morbidity and Mortality

ahrq-logo-pic

 

 

Early Diagnosis, Prevention, and Treatment of Clostridium difficile: Update

Prepared for:
Agency for Healthcare Research and Quality
U.S. Department of Health and Human Services
5600 Fishers Lane
Rockville, MD 20857
March 2016

 

Clostridium difficile is a gram-positive, anaerobic bacterium generally associated through ingestion. Various strains of the bacteria may produce disease generating toxins
and TedA and TedB, as well as the lesser understood binary toxin.

Our use of the term indicates this review’s focus is the presence of clinical disease rather than asymptomatic carriage of C. difficile CDI symptoms can range from mild diarrhea to severe cases including pseudomembranous colitis and toxic megacolon and death.

Estimated U.S. health care associated CDI incidence in 2011 was 95.3 per 100,000, or about
293,000 cases nationally. Incidence is higher among females, whites, and persons 65 years of
age or older. (1)

About one third to one half of health-care onset CDI cases begin in long term care,thus residents in these facilities are at high risk.  Incidence rates may increase by four or five-fold during outbreaks.

Community associated CDI, where CDI occurs outside the institutional setting,
is also on the rise, though still generally lower than institution associated rates and may be in part due to increased surveillance. Estimated community associated CDI was 51.9 per 100,000, or   159,700 cases in 2011.  (1)

Community-associated CDI complicates measuring the effectiveness of  prevention within an institutional setting. 3  Additionally, the pathogenesis of CDI is complex and not
completely understood, and onset may occur as late as several months after hospitalization or antibiotic use

The estimated mortality rate for health -care associated CDI ranged from 2.4 to 8.9 deaths per

100,000 population in 2011.(1) For individuals ≥65 years of age, the mortality rate
was 55.1 deaths per 100,000; (1)

CDI was the 17th leading cause of death in this age group (4)
Hypervirulent C. difficile  strains have emerged since 2000 . These affect a wider population

that includes children, pregnant women, and other healthy
adults, many of whom lack standard risk profiles such as previous hospitalization or antibiotic use.(5)

The hypervirulent strains  account for 51 percent of CDI, compared to only 17 percent
of historical isolates. (6)

Time from symptom development to septic shock may be reduced in the hypervirulent strains, making quick diagnosis and proactive treatment regimens critical for positive outcomes.

To read more on  TREATMENT, PREVENTION, KEY QUESTIONS ——

https://www.effectivehealthcare.ahrq.gov/ehc/products/604/2208/c-difficile-update-report-160329.pdf

Early Diagnosis, Prevention, and Treatment of Clostridium difficile: Update

Prepared for:
Agency for Healthcare Research and Quality
U.S. Department of Health and Human Services
5600 Fishers Lane
Rockville, MD 20857
March 2016

 

Sources:

1Appendix J. References for Appendixes
1.Alcala L, Reigadas E, Marin M, et al.
Comparison of GenomEra C. difficile and Xpert
C. difficile as confirmatory tests in a multistep
algorithm for diagnosis of Clostridium difficile
infection.
J Clin Microbiol 2015 Jan;53(1):332
5. PMID: 25392360.
2.Barkin JA, Nandi N, Miller N, et al.
Super iority
of the DNA amplification assay for the
diagnosis of C. difficile infection: a clinical
comparison of fecal tests.
Dig Dis Sci 2012Oct;57(10):2592-
9. PMID: 22576711.
3.Bruins MJ, Verbeek E, Wallinga JA, et al.
Evaluation of three enzyme immunoassay
s and a loo mediated isothermal amplification test
for the laboratory diagnosis of Clostridium
difficile infection. Eur J Clin Microbiol Infect
Dis 2012 Nov;31(11):3035 9. PMID:
22706512.
4.Buchan BW, Mackey TL, Daly JA, et al.
Multicenter clinical evalu
ation of the portrait
toxigenic C. difficile assay for detection of
toxigenic Clostridium difficile strains in clinical
stool specimens. J Clin Microbiol 2012
Dec;50(12):3932-
6. PMID: 23015667.
5.Calderaro A, Buttrini M, Martinelli M, et al.
Comparative analysis of different methods to
detect Clostridium difficile infection. New
Microbiol 2013 Jan;36(1):57-
63. PMID:
23435816.
6.Carroll KC, Buchan BW, Tan S, et al.
Multicenter evaluation of the Verigene
Clostridium difficile nucleic acid assay.
J ClinMicrobiol 2013 Dec;51(12):4120-
5. PMID:24088862

Patient Safety In Hospitals Nationwide Continued To Improve From 2010 to 2014 With A Decline In Hospital-Acquired Conditions By 17% According To the 2015 QDR Report

P A T I E N T    S A F E T Y     N E W S

This Patient Safety chartbook is part of a family of documents and tools that support the National Healthcare Quality and Disparities Report (QDR).

Patient safety in hospitals nationwide continued to improve from 2010 to 2014, as the overall rate of hospital-acquired conditions (HACs) declined by 17 percent, according to the 2015 National Healthcare Quality and Disparities Report’s         Chartbook on Patient Safety

Examples of HACs include surgical site infections, adverse drug events, pressure ulcers and catheter-associated urinary tract and vascular infections.

The overall HAC rate declined from 145 per 1,000 hospital stays in 2010 to 121 per 1,000 stays in 2013 and remained at that lower rate in 2014. Approximately 2 million harmful events were avoided from 2010 to 2014, saving an estimated 87,000 lives and $20 billion in health care costs.

Researchers found that more than 60 percent of patient safety measures showed improvement from 2001-2002 through 2013.

http://www.ahrq.gov/research/findings/nhqrdr/chartbooks/patientsafety/index.html?utm_source=GOVDEL&utm_medium=PSLS&utm_term=&utm_content=20&utm_campaign=AHRQ_PSCB_2016

 

Get more information on AHRQ’s patient safety resources.

Fecal Microbiota Transplantation (FMT) A Promising Treatment And Recurrent C diff Infections

NurseCadeceus

The media and publications are raising
FMT awareness .

The positive effects are being
noted as FMT’s hold a promising treatment option and success is being witnessed in patients suffering
through C. diff. infections.

Being treated  by a physician with a Fecal Microbiota Transplantation, to treat recurrent Clostridium difficile infections, is resolving the pain and torment being experienced by patients.

What is a Fecal Microbiota Transplant (FMT)?

Fecal microbiota transplants (FMTs) are exactly what they sound like.
They involve taking feces from a healthy person and putting them into the body
of a sick patient to strengthen the community of bacteria that live in the patient’s gut.
FMTs are very effective at curing stubborn infections with Clostridium difficile (C. diff).

The deadly bacteria cause 500,000 illnesses and 14,000 deaths each year in the United States. Small studies have shown that FMTs can cure about 90 percent of serious C. diff infections. They have been so successful that scientists are testing the transplants for other conditions, such as irritable bowel syndrome. (1)

However; this treatment – in any form – has not yet been approved by the
U.S. Food and Drug Administration (FDA).

Clinical data is pending and FMT remains investigational at this time.

Below is the link to the FDA website and the March 2014 document regarding
Fecal Microbiota Transplantation (FMT) for the general public:

III.  When FDA Intends to Exercise Enforcement Discretion 

FDA does not intend to exercise enforcement discretion for the use of an FMT product when the FMT product is manufactured from the stool of a donor who is not known by either the patient or the licensed health care provider treating the patient, or when the donor and donor stool are not qualified under the direction of the treating licensed health care provider.
FDA will continue to evaluate its enforcement policy.
Furthermore, during the period of enforcement discretion, FDA will continue to work with sponsors who intend to submit INDs for use of FMT to treat C. difficile infection not responding to standard therapies.
This enforcement discretion policy does not extend to other uses of FMT.  Data related to the use and study of FMT to treat diseases or conditions other than C. difficile infection are  more limited, and study of FMT for these other uses is not included in this enforcement policy.  (2)
* Also, click on the link below to view the US Food and Drug Administration (FDA)
Upcoming Workshop Information:
**  Always discuss treatment options available with a Healthcare provider
and review/discuss clinical studies in progress.
Resources:

World Health Organization (WHO) World Antibiotic Awareness Week November 16-22

WHOAbtLogo

 

 

 

 

The first World Antibiotic Awareness Week will be held from 16 to 22 November 2015. The campaign aims to increase awareness of global antibiotic resistance and to encourage best practices among the general public, health workers and policy makers to avoid the further emergence and spread of antibiotic resistance.

Facilities Work Together To Protect Patients and Reduce Spreading Infection

CDCantibioticresist2015infographic-a920px

What can be done?

In the case of C diff and CRE a multipronged intervention approach is necessary. The federal government needs to track outbreaks and monitor antibiotic use. The state and local health departments need to coordinate infection control activities. Hospitals and nursing homes need to implement infection control plans and collaborate in sharing data. Doctors need to avoid excessive antibiotic use and practice hand hygiene.

As for the patients, they need to demand action: ask their health care providers what they and the facility are doing to protect the patient from C difficile and CRE infection. Also, patients need to wash their hands and insist that all health care worker wash their hands before touching them.

 

To read the article in its entirety click on link below:

http://www.huffingtonpost.com/manoj-jain-md-mph/coordinated-care-can-redu_b_8031016.html

 

 

Stop the Spread of Antibiotic Resistance and C. difficile Infections

CDCHAICDiffBanner2015vs0815-HAI-Medscape-728x90

Antibiotic-resistant germs cause more than 2 million illnesses and at least 23,000 deaths each year in the US.

Up to 70% fewer patients will get CRE over 5 years if facilities coordinate to protect patients.

Preventing infections and improving antibiotic prescribing could save 37,000 lives from drug-resistant infections over 5 years.

Problem:  Germs spread between patients and across health care facilities.

CDCARMbutton
Antibiotic resistance is a threat.

 

  • Nightmare germs called CRE (carbapenem-resistant Enterobacteriaceae) can cause deadly infections and have become resistant to all or nearly all antibiotics we have today. CRE spread between health care facilities like hospitals and nursing homes when appropriate actions are not taken.
  • MRSA (methicillin-resistant Staphylococcus aureus) infections commonly cause pneumonia and sepsis that can be deadly.
  • The germ Pseudomonas aeruginosa can cause HAIs, including bloodstream infections. Strains resistant to almost all antibiotics have been found in hospitalized patients.
  • These germs are some of the most deadly resistant germs identified as “urgent” and “serious” threats.
C. difficile infections are at historically high rates.
  • C. difficile (Clostridium difficile), a germ commonly found in health care facilities, can be picked up from contaminated surfaces or spread from a healthcare provider’s hands.
  • Most C. difficile is not resistant to antibiotics, but when a person takes antibiotics, some good germs are destroyed. Antibiotic use allows C. difficile to take over, putting patients at high risk for deadly diarrhea.
Working together is vital.
  • Infections and antibiotic use in one facility affect other facilities because of patient transfers.
  • Public health leadership is critical so that facilities are alerted to data about resistant infections, C. difficile, or outbreaks in the area, and can target effective prevention strategies.
  • When facilities are alerted to increased threat levels, they can improve antibiotic use and infection control actions so that patients are better protected.
  • National efforts to prevent infections and improve antibiotic prescribing could prevent 619,000 antibiotic-resistant and C. difficile infections over 5 years.

 

  • “Patients and their families may wonder how they can help stop the spread of infections,” says Michael Bell, M.D., deputy director of CDC’s Division of Healthcare Quality Promotion. “When receiving health care, tell your doctor if you have been hospitalized in another facility or country, wash your hands often, and always insist that everyone have clean hands before touching you.”

CDCantibioticresist2015infographic-a920px

 

 

 

 

 

Antibiotic-resistant germs, those that no longer respond to the drugs designed to kill them, cause more than 2 million illnesses and at least 23,000 deaths each year in the United States. C. difficile caused close to half a million illnesses in 2011, and an estimated 15,000 deaths a year are directly attributable to C. difficile infections.

 The report recommends the following coordinated, two-part approach to turn this data into action that prevents illness and saves lives:

  1. Public health departments track and alert health care facilities to drug-resistant germ outbreaks in their area and the threat of germs coming from other facilities, and
  2. Health care facilities work together and with public health authorities to implement shared infection control actions to stop the spread of antibiotic-resistant germs and C. difficile between facilities.

“Antibiotic resistant infections in health care settings are a growing threat in the United States, killing thousands and thousands of people each year,” said CDC Director Tom Frieden, M.D., M.P.H. “We can dramatically reduce these infections if health care facilities, nursing homes, and public health departments work together to improve antibiotic use and infection control so patients are protected.”

The promising news is that CDC modeling projects that a coordinated approach—that is, health care facilities and health departments in an area working together—could prevent up to 70 percent of life-threatening carbapenem-resistant Enterobacteriaceae (CRE) infections over five years. Additional estimates show that national infection control and antibiotic stewardship efforts led by federal agencies, health care facilities, and public health departments could prevent 619,000 antibiotic-resistant and C. difficile infections and save 37,000 lives over five years.

During the next five years, with investments, CDC’s efforts to combat C. difficile infections and antibiotic resistance under the National Strategy to Combat Antibiotic Resistant Bacteria, in collaboration with other federal partners, will enhance national capabilities for antibiotic stewardship, outbreak surveillance, and antibiotic resistance prevention. These efforts hold the potential to cut the incidence of C. difficile, health care CRE, and MRSA bloodstream infections by at least half.

The proposed State Antibiotic Resistance Prevention Programs (Protect Programs) would implement this coordinated approach. These Protect Programs would be made possible by the funding proposed in the President’s FY 2016 budget request, supporting work with health care facilities in all 50 states to detect and prevent both antibiotic-resistant germs and C. difficile infections. The FY 2016 budget would also accelerate efforts to improve antibiotic stewardship in health care facilities.

 

WHO Healthcare-Associated Infection Pledge 2015

worldaround
C Diff Foundation Pledges Continued Support to Reduce Healthcare-Associated Infections
The C Diff Foundation continues to recognize the serious disease burden and significant economic impact that healthcare-associated infections places on patients and the health care systems throughout the world.

 

Considering that the majority of these infections are treatable and preventable, appreciating the momentum that the Global Patient Safety Challenge program of the WHO World Alliance for Patient Safety is bringing to reduce healthcare-associated infection at the global level.
Emphasizing that a unique opportunity exists to reverse the incidence of healthcare-associated infections, members of the C Diff Foundation shares and pledges……..
To work together to witness a reduction in healthcare–associated infections through the following actions:
• Acknowledging the importance of healthcare-associated infections;
• Developing or expanding ongoing campaigns at national or sub-national levels to promote and improve hand-washing (aka hand hygiene) methods among health care providers;
• Making reliable and validated information available on healthcare-associated infections at community and district levels to foster appropriate actions;
• Sharing experiences and, where appropriate, available surveillance data, with the WHO World Alliance for Patient Safety;
• Consider the use of WHO strategies and guidelines to tackle healthcare-associated infection, in particular in the areas of hand-washing (aka hand hygiene), raise awareness of antibiotic stewardship, and environmental procedure safety.

We will work with health professionals and associations worldwide:
-To promote the highest standards of practice and behavior to reduce the risks of healthcare-associated infection;
-To foster and sustain collaboration with research institutions, training schools, educational centers, universities, healthcare settings, and agencies of other WHO Member States to ensure full utilization of knowledge and experience in the field of healthcare-associated infection.
-To encourage senior management support and role-modeling from key staff to promote the implementation of interventions to reduce healthcare-associated infections.
C Diff Foundation
May 5, 2015

 

For more information about Clean Care is Safer Care, please contact the team at savelives@who.int