New Study Reveals the Impact of Clostridium difficile Infection (CDI) on the Health Service is Equivalent to an Additional 10,670 Bed Days a Year

Vienna (ots/PRNewswire) -

CDI is one of the top ten hospital-acquired infections (HAIs) in
European Hospitals[1] and is estimated to be three times as deadly as
MRSA[2],[3]

Data released at the 27th European Congress of Clinical
Microbiology and Infectious Diseases (ECCMID) 2017 demonstrate the
impact of CDI on the health service amounts to 10,670 bed days over a
year, the equivalent to a fully occupied 30 bed ward, with each CDI
case costing approximately £7,500.[4] In addition, the study
conducted by the Scottish Healthcare Associated Infection Prevention
Institute (SHAIPI), reveals that a sixth of patients cured of the
initial CDI recur within three months and nearly one third of those
have a second recurrence within a year.[4] The SHAIPI CDI study
investigated the clinical outcomes following hospitalisation of
patients with CDI in Scotland and consisted of two analyses; the
first analysis aimed to understand the impact of the infection;[4]
the second investigated clinical outcomes in community associated CDI
(CA-CDI) and hospital associated CDI (HA-CDI).[5]

CDI costs healthcare services approximately EUR3 billion across
Europe each year.[6] Recurrence of CDI occurs in up to 25% of
patients within 30 days of initial treatment with broad-spectrum
antibiotics[7],[8],[9] and patients with one recurrence have an
estimated 40% risk of a further episode.[10] Recurrent CDI is
associated with increased mortality rates and longer hospital
stays.[11],[12] CDI is more common in those taking antibiotics, the
elderly, transplant patients, those with underlying diseases and
hospital patients.[13],[14],[15],[16],[17]

Professor Alistair Leanord, Consultant Microbiologist, University
of Glasgow, commented, "We have seen large reductions in CDI in the
UK over the last decade, however, there has been little change in the
rates of recurrence and death as a result of Clostridium difficile
infection. This study shows that patients with CDI, whether community
or hospital associated, have a doubling of mortality, and a longer
length of stay with a significant cost to the NHS. We now have a
clearer understanding of the national burden of CDI in terms of
recurrences, deaths, cost to the healthcare service and the
increasing importance of community acquisition of infection. This
will allow us to target future interventions in a more focused, cost
effective manner to improve patients' care."

The study was undertaken by the universities of Glasgow,
Strathclyde and Dundee, and data was analysed from 3,304 hospital
cases of CDI and 9,516 controls from August 2010 to July 2013. Of the
total number of CDI cases recorded, 58% came from female patients. In
terms of mortality, 29% of those with CDI died within two months
compared to 14% of control cases and hazard ratio of death was also
found to be 2.1 times greater for CDI cases compared to controls (95%
1.9, CI 2.5). With regard to time spent in hospitals, those with CDI
had an estimated additional length of stay of 9.7 days compared to
controls.[4]

The second data analysis consisted of 1,297 CA-CDI cases and 3,980
controls and 2,007 HA-CDI cases and 5,536 controls. Results suggest
that, compared to controls, mortality rates are higher amongst HA-CDI
cases (33.0% vs 17.7%) than in CA-CDI cases (22.4% vs 9.6%). Median
length of stay was 7.2 days greater than controls for CA-CDI cases
and 12.0 days greater for HA-CDI cases.[5]

Professor Mark Wilcox, Professor of Medical Microbiology, Leeds
Teaching Hospitals & University of Leeds, commented, "These new
studies focus on the outcomes associated with CDI, including
community- and hospital-associated cases. The findings, based on
large groups of cases and control patients, emphasise the
considerable healthcare and societal burdens of CDI. Notably there
was a doubling risk of death for both community- and
hospital-associated CDI cases compared with (non-CDI) control
patients." He continued, "Furthermore, the lengths of hospital stay
for both groups of CDI cases was about twice as long as that for
controls; these add up to a substantial burden on the NHS, at a time
of major service pressures. The figures mean that we must optimise
efforts to prevent CDI and to treat cases optimally to reduce the
risk of recurrent infections."

Reducing the threat and the burden of infectious diseases like CDI
is increasingly linked to antibiotic stewardship.[18] In this
context, inappropriate use of antibiotics may cause the development
of antimicrobial resistance,[19] increasing risk of CDI and other
medical complications.[13],[15],[20] CDI is also often treated with
broad-spectrum antibiotics that further damage the 'good' bacteria,
increasing the risk of the CDI returning.[10],[21] Refining and
optimising the use of antibiotics in the treatment of CDI therefore
has the potential to serve as an accepted practice example for
antibiotic stewardship in the treatment of infectious diseases.

About Clostridium difficile infection

Clostridium difficile infection (CDI) is a recurring and
preventable bacterial infection of the colon that causes severe and
potentially deadly diarrhoea.[14],[15],[22] C. difficile bacteria are
naturally present in the gut of up to 3% of healthy adults, usually
without any problems. This is because the colonising C. difficile
bacteria are 'kept under control' by the 'good bacteria'.[15] An
alteration in the balance of the gut microflora, often caused by
broad-spectrum antibiotics, can reduce the number of 'good' bacteria,
allowing C. difficile to multiply and cause inflammation, severe
diarrhoea and potentially life-threatening complications.[14],[15]
CDI is one of the top ten hospital-acquired infections (HAIs) in
European hospitals[1] and is estimated to be three times as deadly as
MRSA.[2],[3] People in hospital with CDI are up to three times more
likely to die in hospital (or within a month of infection) than those
without CDI.[23],[24] Recurrence has been identified by the European
Society of Clinical Microbiology and Infectious Diseases (ESCMID) as
the most important problem in the treatment of CDI,[25] and occurs in
up to 25% of patients within 30 days of initial treatment with
broad-spectrum antibiotics.[7],[8],[9]

About Scottish Healthcare Associated Infection Prevention
Institute (SHAIPI)

The Scottish Healthcare Associated Infection Prevention Institute
(SHAIPI) has been set up with Scottish Government funding via the
Scottish Infection Research Network (SIRN). It involves partnerships
with a number of Scottish universities, NHS stakeholders and industry
to develop research in the three main areas of molecular
epidemiology, informatics and applied infection prevention and
control to tackle the threat to public health from emergent
healthcare associated infections and antimicrobial resistance,
utilising rapid knowledge transfer, state of the art laboratory
techniques and novel interventions.[26]

About the SHAIPI study

The SHAIPI CDI study investigated the clinical outcomes following
hospitalisation of patients with CDI in Scotland. The primary
analysis 'Clinical outcomes following hospitalisation with
Clostridium difficile' aimed to quantify the impact of CDI on
recurrence of CDI, mortality, readmissions to hospital and length of
stay, in order to understand the impact of the infection.[4] The
second analysis 'Clinical outcomes following community associated and
hospital associated Clostridium difficile infection: matched
case-control studies' investigated the recurrence of CDI and
readmissions to hospital, in both community associated CDI (CA-CDI)
and hospital associated CDI (HA-CDI) cases, and mortality and length
of stay in CA-CDI cases compared to controls and HA-CDI cases
compared to controls.[5] The research was funded by Astellas Pharma
EMEA.

About Astellas Pharma EMEA

Astellas Pharma EMEA operates in 40 countries across Europe, the
Middle East and Africa, and is the EMEA regional business of
Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company
dedicated to improving the health of people around the world through
the provision of innovative and reliable pharmaceuticals. The
organisation's focus is to deliver outstanding R&D and marketing to
continue growing in the world pharmaceutical market. Astellas
presence in Europe also includes an R&D site and three manufacturing
plants. The company employs over 4,500 people across the EMEA region.
In 2013 Astellas was awarded SCRIP Pharmaceutical Company of the Year
in recognition of its commercial success and pipeline development.

References

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.pdf (last accessed April 2017).

2. Bauer MP, et al. Clostridium difficile infection in Europe: a
hospital-based survey. Lancet. 2011;377:63-73.

3. European Centre for Disease Prevention and Control/European
Medicines Agency (ECDC/EMEA). Joint technical report The bacterial
challenge: time to react. Stockholm: ECDC / EMEA; 2009. Available
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_Bacterial_Challenge_Time_to_React.pdf (last accessed April 2017).

4. Data on file, AI/17/0003/APEL, Astellas Pharma Europe Ltd,
April 2017.

5. Data on file, AI/17/0002/APEL, Astellas Pharma Europe Ltd,
April 2017.

6. Kuijper EJ, et al. ESCMID study group for Clostridium
difficile. Emergence of Clostridium difficile associated disease in
North America and Europe. Clin Microbiol Infect. 2006;12:2-18.

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Clostridium difficile Infection: Results From Two Multinational,
Randomized, Controlled Trials. Clin Infect Dis. 2014;59(3):345-54.

8. Lowy I, et al. Treatment with monoclonal antibodies against
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9. Louie TJ, et al. Fidaxomicin versus vancomycin for Clostridium
difficile infection. N Engl J Med. 2011;364:422-31.

10. Kelly CP, LaMont JT. Clostridium difficile - more difficult
than ever. N Engl J Med. 2008;359(18):1932?1940.

11. Olsen MA, et al. Recurrent Clostridium difficile infection is
associated with increased mortality. Clin Microbiol Infect. 2014;1-7.

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associated diarrhoea: a cost-of-illness study from a German tertiary
care hospital. Infection. 2015:43:707.

13. Barbut F, Petit JC. Epidemiology of Clostridium Difficile
Associated Infections. Clin Microbiol Infect. 2001;7:405-10.

14. McMaster-Baxter NL, Musher DM. Clostridium difficile: recent
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15. Sunenshine R, McDonald L. Clostridium difficile-associated
disease: new challenges from an established pathogen. Cleve Clin J
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16. Klingler PJ, et al. Clostridium difficile Infection: Risk
Factors, Medical and Surgical Management. Digestive Diseases
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17. Donnelly JP et al. Hospital-Onset Clostridium difficile
Infection Among Solid Organ Transplant Recipients. J Am
Transplantation. 2015:15(11):2970-2977.

18. Mamoon A. An evaluation of the impact of antibiotic
stewardship on reducing the use of high-risk antibiotics and its
effect on the incidence of Clostridium difficile infection in
hospital settings. Journal of antimicrobial chemotherapy.
2012:67(12):2988-2996.

19. Bell BG. A systematic review and meta-analysis of the effects
of antibiotic consumption on antibiotic resistance. BMC Infectious
Diseases. 2014;14:13.

20. Bignardi GE. Risk factors for Clostridium difficile infection.
J Hospital Infect. 1998:40:1-15.

21. Louie TJ, et al. Fidaxomicin preserves the intestinal
microbiome during and after treatment of Clostridium difficile
infection (CDI) and reduces both toxin reexpression and recurrence of
CDI. Clinical Infectious Diseases. 2012:2:S132-142.

22. Ananthakrishnan AN. Clostridium difficile infection:
epidemiology, risk factors and management. Nat Rev Gastroenterol
Hepatol. 2011;8:17-26.

23. Oake N, et al. The effect of hospital acquired Clostridium
difficile infection on in-hospital mortality. Arch Intern Med.
2010;1701804-10.

24. Hensgens MP, et al. All-Cause and disease-specific mortality
in hospitalized patients with Clostridium difficile infection: a
Multicenter Cohort Study. Clin Infect Dis. 2013;56:1108-16.

25. Bauer MP, et al. European Society of Clinical Microbiology and
Infectious Disease (ESCMID): treatment guidance document for
Clostridium difficile-infection (CDI). Clin Microbiol Infect.
2009;15:1067-79.

26. Scottish Healthcare Associated Infection Prevention Institute.
About SHAIPI. Available from: http://www.gla.ac.uk/researchinstitutes
/iii/research/researchcentres/sirn/shaipi/welcometoshaipi/ (last
accessed April 2017).

April 2017

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