c.difficile
TRANSCRIPT
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MANAGEMENT OF CLOSTRIDIUM DIFFICILE INFECTION (CDI):
A TOPIC REVIEW
Tauhid Ahmed Bhuiyan, PharmDPGY-1 Resident (Year 1)
Pharmacy Practice Residency
King Faisal Specialist Hospital and Research Center (KFSHRC) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. (UAN# 0833-0000-14-039– L01-P, 0833-0000-14-039– L01-T)
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Objectives
Familiarize with the background, epidemiology, and general overview of CDI
Identify key elements for diagnosing CDI
Discuss contemporary management strategies of CDI
Recognize key infection control measures as well as understand pharmacists’ role in prevention of the disease
I do not have financial relationship and no actual or potential conflict of interest in relation to this activity
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Background Gram-positive, anaerobic, spore forming organism, first isolated in 1935
Found in soil, human and animal feces, and food products (e.g. processed meats)
Produce two types of toxin Toxin A Toxin B (primary toxin responsible for CDI)
Most common causes of hospital acquired infection along with methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococci (VRE)
Common cause of infectious diarrhea in hospitals and long-term care (LTC) settings
Khanna S. et al. Ther Adv Gastroenterol 2014; 7(2):72-86
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Case Definition of CDI
An episode of CDI is defined as: Presence of diarrhea
Passage of ≥ 3 unformed stool in 24 hours or fewer consecutive hours
Positive stool test result for presence of toxigenic C. difficile or its toxins or histopathologic findings demonstrating pseudomembranous colitis
Rarely (<1% of cases), a symptomatic patient will present with ileus and colonic distension with minimal or no diarrhea
Cohen SH. et al. Infect Control Hosp Epidemiol 2010; 31(5):431-455
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Epidemiology
C. difficile is recognized as: Primary pathogen responsible for antibiotic-associated colitis 15%-25% of cases of nosocomial antibiotic-associated diarrhea
Disease burden: 20%-30% of cases of antibiotic-associated diarrhea The cost attributed to CDI in the US varies from $2470.00−$3669.00
per episode
According to Center for Disease Control (CDC) C. difficile causes diarrhea links to 14,000 deaths each year
Cohen SH. et al. Infect Control Hosp Epidemiol 2010; 31(5):431-455Silva M. Einstein 2012; 10(1):105-9
Clostridium Difficile Infection. www.cdc.gov
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Surveillance Definition Community onset, healthcare facility-associated (CO-HCFA)
Symptom onset in the community or within 48 hours of hospital admission + discharge from healthcare facility within the previous 4 weeks
Hospital onset, healthcare facility-associated (HO-HCFA) Onset of symptoms >48 hours after admission or <4 weeks after discharge from health care
facility
Intermediate Symptom onset occurs in the community between 4-12 weeks after discharge from a hospital
Community associated Not discharged from healthcare facility in the previous 12 weeks
Cohen SH. et al. Infect Control Hosp Epidemiol 2010; 31(5):431-455
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Natural History
CDAD: Clostridium Difficile Associated DiarrheaHCW: Health Care Worker http://www.clevelandclinicmeded.com/medicalpubs/
diseasemanagement/infectious-disease/clostridium-difficile-infection
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Pathogenesis
http://www.cdiff-support.co.uk/about.htm
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Etiology
Exogenous Transmission through
Fecal-oral route Person to person spread Fomites Hospital equipment or furniture
Endogenous Small amount found in natural flora in the small intestine Exposure to antibiotic suppresses natural flora “niche” for C.
difficile to flourish
Cohen SH. et al. Infect Control Hosp Epidemiol 2010; 31(5):431-455
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Risk Factors
Major risk factor Likely risk factor
Age >64 years Immune compromised (e.g. AIDS, cancer)
Recent hospitalization Consumption of contaminated food products
Increased length of hospital stay Inflammatory bowel disease
Long term care (LTC) facility residence Use of proton-pump inhibitors
Antibiotic exposure Gastrointestinal endoscopic procedures
Contact with active carriers
Khanna S. et al. Mayo Clin Proc. 2012; 87(11):1106-1117
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Complications of Severe CDI
Dehydration
Electrolyte disturbances
Hypoalbuminemia
Toxic megacolon
Hypotension
Renal Failure
Systemic inflammatory response syndrome (SIRS)
Bowel perforation
Cohen SH. et al. Infect Control Hosp Epidemiol 2010; 31(5):431-455
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Diagnosis
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Clinical Presentation
Symptomless carriage—mild or moderate diarrhea–fulminant and sometimes fatal pseudomembranous colitis
Watery diarrhea is the cardinal symptom accompanied by Lower abdominal pain and cramping (20%-33%) Fever (30%-50%) Leukocytosis (50%-60%)
Patient with severe disease may develop colonic ileus or toxic dilatation with minimal or no diarrhea
Cohen SH. et al. Infect Control Hosp Epidemiol 2010; 31(5):431-455
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Assessment of Severity
Clinical definition Supportive clinical data
Mild to moderate Leukocytosis with WBC< 15,000
cells/μL Serum Creatinine (Scr) < 1.5 X baseline
Severe Leukocytosis with WBC ≥ 15,000
cells/μL Scr ≥ 1.5 X baseline
Severe-complicated Hypotension or shock, ileus, toxic megacolon
Cohen SH. et al. Infect Control Hosp Epidemiol 2010; 31(5):431-455
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Laboratory Investigations
Confirmatory test Stool examination
Other test for disease severity Complete blood count (CBC) Electrolytes Albumin levels Serum lactate levels
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Stool Tests
Test Sensitivity (%)
Specificity (%) Advantages Disadvantages
Cell Cytotoxicity Assay 80-90 99-100Considerably high sensitivity and specificity; considered as gold standard
Takes 24-48 hr to complete; requires tissue culture facility; cost; detects only toxin B
Enzyme Immunoassay (EIA) Toxin test 65-85 95-100 Fast (2-6 hr), easy to
perform, high specificityLack of sensitivity than cell cytotoxicity assay; detects both toxin A and B
Stool Culture 90-100 98-100 Most sensitive, essential for epidemiologic studies
Takes 2-5 days to complete; labor intensive; not specific for toxin-producing bacteria
Latex Agglutination Assay for Glutamate Dehydrogenase (GDH)
58-68 80-96 Fast, inexpensive, easy to perform
Poor sensitivity and specificity needed to establish diagnosis; requires confirmatory test
PCR assay toxin gene detection 92-97 100
Excellent sensitivity and specificity compared with cytotoxin assay
Not in routine practice
Aberra FN. et al. Clostridium Difficile Colitis. www.medscape.com. March 17, 2014
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Imaging
Endoscopy Not generally used in making initial diagnosis Used in high suspicion despite normal stool tests or ileus
secondary to CDI Findings of pseudomembranes are not specific but sensitive to
CDI diagnosis
Computed tomography (CT) Suggestive of CDI include bowel wall thickening, peri-colonic
stranding Dilated colon may indicate severe-complicated CDI
Khanna S. et al. Mayo Clin Proc. 2012; 87(11):1106-1117
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Management
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Goals of Therapy
Short term: Resolution of signs and symptoms of CDI infections Progression of the disease
Long term: Prevention of recurrences
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General Measures
Supportive care and careful management of fluid and electrolyte
Discontinuation of unnecessary antimicrobial therapy
Avoidance of anti-motility agents
Reviewing of PPI use
Khanna S. et al. Ther Adv Gastroenterol 2014; 7(2):72-86
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Treatment
Pharmacological Agents with activity against C. difficile organisms
Non-pharmacological Fecal Microbiota Transplantation (FMT) Surgical Management
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Pharmacological Agents
Approved Unapproved/Unlabeled
Vancomycin Metronidazole
Fidaxomicin Nitazoxanide
Rifaximin
Immunotherapy
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Treatment Guidance (Adults)
Clinical Definitions Recommended Treatment Initial episode, mild or moderate
Metronidazole, 500 mg orally every 8 hours for 10-14 days
Initial episode, severe Vancomycin, 125 mg orally every 6 hours for 10-14 days
Initial episode, severe, complicated
Vancomycin 500 mg orally every 6 hours + Metronidazole 500 mg every 8 hours intravenously (IV)Note: consider adding rectal instillation
First recurrence Same as initial episodeSecond recurrence Vancomycin tapered and/or pulse regimen*
First 2 weeks: 125 mg PO q6hThird week: 125 mg PO BIDFourth week: 125 mg PO dailyNext 2-8 weeks: 125 mg every 2 to 3 days
*
Cohen SH. et al. Infect Control Hosp Epidemiol 2010; 31(5):431-455
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Metronidazole
Inexpensive, widely used as a first-line treatment for CDI
Compared to vancomycin alone: Similar efficacy for mild to moderate infection Not recommended beyond the first recurrence/long term therapy;
“possible cumulative neurotoxicity” Only 6%-15% excreted in stool
Adverse effects: Nausea, disulfiram-like reaction, metallic taste, peripheral neuropathy
Not routinely recommended for use in children or in women during lactation or pregnancy
Khanna S. et al. Mayo Clin Proc. 2012; 87(11):1106-1117
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Vancomycin First FDA approved labeled indication for treatment of CDI
More expensive than metronidazole; minimal oral absorption
Use is discouraged as initial treatment to decrease selection pressure for the emergence of VRE
Usage: When metronidazole is found to be ineffective If metronidazole is contraindicated or not well tolerated Initial treatment option of severe CDI
For severe complicated CDI, higher dose (250-500 mg 4 times a day) is used as a supplemented therapy along with IV metronidazole
Khanna S. et al. Mayo Clin Proc. 2012; 87(11):1106-1117
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Comparative Effectiveness
Initial Cure:
Drekonja DM. et al. Ann Intern Med. 2011;155:839-847
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Fidaxomicin (Dificid®)
FDA approved (2011) for indication of C. difficile-associated diarrhea (CDAD)
Narrow spectrum macrocyclic antibiotic that targets bacterial RNA polymerase
Activity against gram-positive aerobic and anaerobic organisms
Dose & duration: 200 mg by mouth twice a day for 10 days
Safe and effective for the first episode of C. difficile infection, however, there is limited evidence for recurrent infection
Khanna S. et al. Mayo Clin Proc. 2012; 87(11):1106-1117
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Initial Episode of Mild-to-Moderate CDI
Fidaxomicin (200 mg twice daily) was compared to oral vancomycin (125 mg 4 times daily) in 2 randomized control trials (RCT) for duration of 10 days
Both trial found fidaxomicin noninferior to vancomycin in terms of clinical cure
Fidaxomicin was also associated with a lower recurrence rate within 28 days of clinical cure relative to vancomycin
Louie TJ et al. N Engl J Med 2011; 364:422-431
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Pharmacokinetic Advantage
Minimal systemic absorption after oral administration
>92% excreted in the feces as unchanged drug and metabolites
Concentrations in feces substantially exceed the 90% MIC of C. difficile
Postantibiotic effects against C. difficile in clinical studies range from 6-10 hours
Lexi-Comp OnlineTM , Lexi-Drugs Multinational , Hudson, Ohio: Lexi-Comp, Inc.; September 19, 2014
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Alternative Agents
Nitazoxanide
Rifaximin
Immunotherapy
Probiotics
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Nitazoxanide
Antiparasitic agent, active against C. difficile
Musher et al. compared nitazoxanide in at 2 durations to metronidazole in a prospective, randomized, double-blinded study involving 142 patients with CDI Results showed that nitazoxanide is as effective as metronidazole with
similar response rate (90% vs. 82%) and recurrence rates ( 18% vs. 23%)
Lacks long term safety and efficacy data
Khanna S. et al. Ther Adv Gastroenterol 2014; 7(2):72-86
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Rifaximin
Used as an adjunct to treat patient with multiple CDI recurrences
Course is given in a form of “rifaximin chaser” (400 mg orally for 14 days)
A recent RCT found that rifaximin was similar to vancomycin (57% vs. 64%) in attaining clinical success and was non-inferior in resolution of diarrhea (80% vs. 81%) and recurrence (9% vs. 14%)
Khanna S. et al. Ther Adv Gastroenterol 2014; 7(2):72-86
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Immunotherapy (IVIG)
Variable success
No RCT trials showing benefit of IVIG for CDI
Its mechanism may relate to antibodies against C. difficile toxin A and toxin B
In a large, randomized, controlled trial of monoclonal antibody against C. difficile toxin A and toxin B in addition to antibiotic therapy Rate of recurrence rate was lower among patient treated with
monoclonal antibody (7% vs. 25%; p <0.001)Khanna S. et al. Ther Adv Gastroenterol 2014; 7(2):72-86
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Probiotics
Goal is to repopulate the colonic microflora
Commonly used species Lactobacillus, Bifedobacterium, and Saccharomyces
Currently has no role in the primary prevention of CDI
Khanna S. et al. Ther Adv Gastroenterol 2014; 7(2):72-86
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Non-pharmacological Treatment
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Fecal Microbiota Transplantation (FMT)
Alternative to standard antibiotic therapy to treat recurrent CDI
Restoration of colonic flora with the use of intestinal microorganisms from a healthy donor (via infusion of a liquid suspension of stool)
A systemic review of 317 patients with recurrent CDI treated via FMT found overall success rate of 92%, with 89% of patients responding after a single treatment
Khanna S. et al. Ther Adv Gastroenterol 2014; 7(2):72-86
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Surgical Management
Indicated for treatment of refractory CDI not responding to medical therapy, or for fulminant colitis or toxic megacolon
Traditional surgical approach—subtotal or total colectomy
Poor outcome with mortality as high as 50%
Khanna S. et al. Mayo Clin Proc. 2012; 87(11):1106-1117
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Recurrent CDI
Major drawback in management of CDI
Occurs 20%-25% of patients after first dose
Defined as “occurrence of symptomatic diarrhea or abdominal pain, with positive stool test within 56 days of previous episode after interim symptom resolution”
Khanna S. et al. Mayo Clin Proc. 2012; 87(11):1106-1117
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Management of Recurrent CDI
Khanna S. et al. Mayo Clin Proc. 2012; 87(11):1106-1117
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Infection Control Measures
Hand hygiene
Contact precautions Glove use Gowns
Isolation rooms or cohorting
Environmental cleaning, disinfection, or use of disposables Patient room, equipment between uses Elimination of rectal thermometer usage Use of hypochlorite for disinfection
Cohen SH. et al. Infect Control Hosp Epidemiol 2010; 31(5):431-455
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“Three Big Role”
Identify potential risk factors
Evaluate antibiotic usage
Education
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Summary
Clostridium difficile is a Gram-positive, anaerobic, spore forming organism that produces two types of toxin: A & B
Major risk factors of CDI include elderly (age >64 years), antibiotic exposure, recent hospitalization or LTC facility residence
Toxin detection assay such as cell cytotoxic assay or EIA are considered as suitable alternatives
Metronidazole is considered as first line for initial episode of mild-to-moderate infection and should not be used beyond first recurrence
Vancomycin is reserved for severe CDI and the dose is 125 mg PO 4 times a day for 10-14 days
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Summary
Fidaxomicin has been shown to be non-inferior to vancomycin in terms of clinical cure in addition to lower rates of recurrences, however, use is limited by high cost
Alternate agents such as, nitazoxanide, rifaximin, IVIG, or probiotics, do not get used routinely in clinical practice due to lack of substantial evidence
Non-pharmacological management such as FMT, or surgery is indicated in the case of multiple recurrences or refractory CDI
Proper hand hygiene and contact precautions are considered to be the cornerstone when it comes to infection control and nosocomial transmission
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Self Assessment Questions????
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Q1: Identify the CORRECT statement regarding Clostridium difficile infection (CDI):
a) It caused by aerobic, Gram-negative bacilli
b) The primary toxin responsible for causing the infection is toxin A
c) It is a common cause of infectious diarrhea in the community
d) Use of broad spectrum antibiotic is responsible for most CDI cases
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Q2: Which of the following is one of the means of acquiring CDI?
a) Alteration of gut flora using antibiotic
b) Fecal-to-oral transmission
c) Through contaminated environment
d) All of the above
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Q3: Case R.J is a 65 year old female who was recently discharged from
hospital after being treated for hospital acquired pneumonia. For past 2 days R.J has been passing watery stool for >3-4 times a day. She was brought to the Emergency and was diagnosed with CDI. Which of the following treatment regimen is appropriate for R.J?
a) Vancomycin 125 mg PO 4 times a day for 10-14 daysb) Fidaxomicin 200 mg PO twice a day for 10 daysc) Vancomycin 500 mg orally every 6 hours + Metronidazole 500 mg
every 8 hours intravenously d) Metronidazole 500 mg orally every 8 hours for 10-14 dayse) None of the above
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Q4:Which of the following statement is FALSE regarding management of CDI?
a) Oral vancomycin is initial treatment option for severe CDI
b) Fidaxomicin is FDA approved for treatment of CDAD
c) Rifaximin is used as adjunct to treat multiple CDI recurrences in the form of “rifaximin chaser”
d) Use of Probiotics has clinical role in the primary prevention of CDI
e) None of the above
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Q5: Which of the following is FDA approved for treatment of C. difficile?
a) Vancomycin
b) Metronidazole
c) Fidaxomicin
d) Vancomycin + Fidaxomicin