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Guideline Summary
Guideline Title
Clinical practice guidelines for Clostridium difficile infection in adults: 2010 update by the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA).
Bibliographic Source(s)
Cohen SH, Gerding DN, Johnson S, Kelly CP, Loo VG, McDonald LC, Pepin J, Wilcox MH. Clinical practice guidelines for Clostridium difficile infection in adults: 2010 update by the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA). Infect Control Hosp Epidemiol. 2010 May;31(5):431-55. [233 references] PubMed External Web Site Policy
Guideline Status

This is the current release of the guideline.

Scope

Disease/Condition(s)

Clostridium difficile infection (CDI)

Note: A case of CDI is defined by the presence of symptoms (usually diarrhea) and either a stool test positive for C. difficile toxins or toxigenic C. difficile, or colonoscopic or histopathologic findings revealing pseudomembranous colitis.

Guideline Category
Diagnosis
Prevention
Treatment
Clinical Specialty
Critical Care
Geriatrics
Infectious Diseases
Internal Medicine
Nursing
Preventive Medicine
Intended Users
Advanced Practice Nurses
Hospitals
Managed Care Organizations
Nurses
Physician Assistants
Physicians
Guideline Objective(s)

To improve the diagnosis and management of Clostridium difficile infection (CDI) in adult patients

Target Population

Adult patients with Clostridium difficile infection (CDI)

Interventions and Practices Considered

Diagnosis

  1. Conduct surveillance programs
  2. Testing for Clostridium difficile with stool culture, enzyme immunoassay (EIA), toxin testing (2-step method using EIA detection of glutamate dehydrogenase and then cell cytotoxicity assay or toxigenic culture), and polymerase chain reaction (PCR)

Prevention/Management/Treatment

  1. Use of gloves and gowns
  2. Proper hand hygiene including washing with soap (or antimicrobial soap) and water
  3. Use of private rooms, when applicable
  4. Maintenance of contact precautions
  5. Environmental cleaning and disinfection
  6. Antimicrobial use restriction
  7. Avoidance of antiperistaltic agents
  8. Initiate empirical treatment including metronidazole and vancomycin
  9. Colectomy
Major Outcomes Considered
  • Sensitivity and specificity of diagnostic tests
  • Rate of Clostridium difficile infection
  • Morbidity

Methodology

Methods Used to Collect/Select the Evidence
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

For the 2010 update, the Society for Healthcare Epidemiology of America - Infectious Diseases Society of America (SHEA-IDSA) Expert Panel completed the review and analysis of data published since 1994. Computerized literature searches of PubMed were performed. The searches of the English-language literature from 1994 through April 2009 used the terms "Clostridium difficile," "epidemiology," "treatment," and "infection control" and focused on human studies.

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence

Quality of Evidence*

  1. Evidence from at least 1 properly randomized, controlled trial
  2. Evidence from at least 1 well-designed clinical trial without randomization, from cohort or case-controlled analytic studies (preferably from more than 1 center), from multiple time series, or from dramatic results from uncontrolled experiments
  3. Evidence from opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees

*Adapted from the Canadian Task Force on the Periodic Health Examination.

Methods Used to Analyze the Evidence
Review of Published Meta-Analyses
Systematic Review
Description of the Methods Used to Analyze the Evidence

In evaluating the evidence regarding the management of Clostridium difficile infection (CDI), the Expert Panel followed a process used in the development of other Society for Healthcare Epidemiology of America - Infectious Diseases Society of America (SHEA-IDSA) guidelines. The process included a systematic weighting of the quality of the evidence and the strength of each recommendation (see "Rating Scheme for the Strength of the Evidence" and "Rating Scheme for the Strength of the Recommendations" fields).

Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations

Not stated

Rating Scheme for the Strength of the Recommendations

Strength of Recommendation*

  1. Good evidence to support a recommendation for or against use
  2. Moderate evidence to support a recommendation for or against use
  3. Poor evidence to support a recommendation

*Adapted from the Canadian Task Force on the Periodic Health Examination.

Cost Analysis

A formal cost analysis was not performed and published cost analyses were not reviewed.

Method of Guideline Validation
Peer Review
Description of Method of Guideline Validation

Not stated

Recommendations

Major Recommendations

Quality of evidence (I–III) and strength of recommendation (A–C) ratings are defined at the end of the "Major Recommendations" field.

  1. Epidemiology: What are the minimum data that should be collected for surveillance purposes and how should the data be reported?
    1. To increase comparability between clinical settings, use available standardized case definitions for surveillance of (1) healthcare facility (HCF)-onset, HCF-associated Clostridium difficile infection (CDI); (2) community-onset, HCF-associated CDI; and (3) community-associated CDI (see Figure 1 in the original guideline document) (B-III).
    2. At a minimum, conduct surveillance for HCF-onset, HCF-associated CDI in all inpatient healthcare facilities, to detect outbreaks and monitor patient safety (B-III).
    3. Express the rate of healthcare-associated CDI as the number of cases per 10,000 patient-days (B-III).
    4. If CDI rates are high compared with those at other facilities or if an outbreak is noted, stratify rates by patient location in order to target control measures (B-III).
  1. Diagnosis: What is the best testing strategy to diagnose CDI in the clinical laboratory and what are acceptable options?
    1. Testing for C. difficile or its toxins should be performed only on diarrheal (unformed) stool, unless ileus due to C. difficile is suspected (B-II).
    2. Testing of stool from asymptomatic patients is not clinically useful, including use as a test of cure. It is not recommended, except for epidemiological studies. (B-III)
    3. Stool culture is the most sensitive test and is essential for epidemiological studies (A-II).
    4. Although stool culture is not clinically practical because of its slow turnaround time, the sensitivity and specificity of stool culture followed by identification of a toxigenic isolate (i.e., toxigenic culture), as performed by an experienced laboratory, provides the standard against which other clinical test results should be compared (B-III).
    5. Enzyme immunoassay (EIA) testing for C. difficile toxin A and B is rapid but is less sensitive than the cell cytotoxin assay, and it is thus a suboptimal alternative approach for diagnosis (B-II).
    6. Toxin testing is most important clinically, but is hampered by its lack of sensitivity. One potential strategy to overcome this problem is a 2-step method that uses EIA detection of glutamate dehydrogenase (GDH) as initial screening and then uses the cell cytotoxicity assay or toxigenic culture as the confirmatory test for GDH-positive stool specimens only. Results appear to differ based on the GDH kit used; therefore, until more data are available on the sensitivity of GDH testing, this approach remains an interim recommendation. (B-II)
    7. Polymerase chain reaction (PCR) testing appears to be rapid, sensitive, and specific and may ultimately address testing concerns. More data on utility are necessary before this methodology can be recommended for routine testing. (B-II)
    8. Repeat testing during the same episode of diarrhea is of limited value and should be discouraged (B-II).
  1. Infection Control and Prevention: What are the most important infection control measures to implement in the hospital during an outbreak of CDI?
    1. Measures for Healthcare Workers, Patients, and Visitors
      1. Healthcare workers and visitors must use gloves (A-I) and gowns (B-III) on entry to a room of a patient with CDI.
      2. Emphasize compliance with the practice of hand hygiene (A-II).
      3. In a setting in which there is an outbreak or an increased CDI rate, instruct visitors and healthcare workers to wash hands with soap (or antimicrobial soap) and water after caring for or contacting patients with CDI (B-III).
      4. Accommodate patients with CDI in a private room with contact precautions (B-III). If single rooms are not available, cohort patients, providing a dedicated commode for each patient (C-III).
      5. Maintain contact precautions for the duration of diarrhea (C-III).
      6. Routine identification of asymptomatic carriers (patients or healthcare workers) for infection control purposes is not recommended (A-III) and treatment of such identified patients is not effective (B-I).
    1. Environmental Cleaning and Disinfection
      1. Identification and removal of environmental sources of C. difficile, including replacement of electronic rectal thermometers with disposables, can reduce the incidence of CDI (B-II).
      2. Use chlorine-containing cleaning agents or other sporicidal agents to address environmental contamination in areas associated with increased rates of CDI (B-II).
      3. Routine environmental screening for C. difficile is not recommended (C-III).
    1. Antimicrobial Use Restrictions
      1. Minimize the frequency and duration of antimicrobial therapy and the number of antimicrobial agents prescribed, to reduce CDI risk (A-II).
      2. Implement an antimicrobial stewardship program (A-II). Antimicrobials to be targeted should be based on the local epidemiology and the C. difficile strains present, but restricting the use of cephalosporin and clindamycin (except for surgical antibiotic prophylaxis) may be particularly useful (C-III).
    1. Use of Probiotics
      1. Administration of currently available probiotics is not recommended to prevent primary CDI, as there are limited data to support this approach and there is a potential risk of bloodstream infection (C-III).
  1. Treatment: Does the choice of drug for CDI matter and, if so, which patients should be treated and with which agent?
    1. Discontinue therapy with the inciting antimicrobial agent(s) as soon as possible, as this may influence the risk of CDI recurrence (A-II).
    2. When severe or complicated CDI is suspected, initiate empirical treatment as soon as the diagnosis is suspected (C-III).
    3. If the stool toxin assay result is negative, the decision to initiate, stop, or continue treatment must be individualized (C-III).
    4. If possible, avoid use of antiperistaltic agents, as they may obscure symptoms and precipitate toxic megacolon (C-III).
    5. Metronidazole is the drug of choice for the initial episode of mild-to-moderate CDI. The dosage is 500 mg orally 3 times per day for 10–14 days. (A-I)
    6. Vancomycin is the drug of choice for an initial episode of severe CDI. The dosage is 125 mg orally 4 times per day for 10–14 days. (B-I)
    7. Vancomycin administered orally (and per rectum, if ileus is present) with or without intravenously administered metronidazole is the regimen of choice for the treatment of severe, complicated CDI. The vancomycin dosage is 500 mg orally 4 times per day and 500 mg in approximately 100 mL normal saline per rectum every 6 hours as a retention enema, and the metronidazole dosage is 500 mg intravenously every 8 hours. (C-III)
    8. Consider colectomy for severely ill patients. Monitoring the serum lactate level and the peripheral blood white blood cell count may be helpful in prompting a decision to operate, because a serum lactate level rising to 5 mmol/L and a white blood cell count rising to 50,000 cells per µL have been associated with greatly increased perioperative mortality. If surgical management is necessary, perform subtotal colectomy with preservation of the rectum. (B-II)
    9. Treatment of the first recurrence of CDI is usually with the same regimen as for the initial episode (A-II) but should be stratified by disease severity (mild-to-moderate, severe, or severe complicated), as is recommended for treatment of the initial CDI episode (C-III).
    10. Do not use metronidazole beyond the first recurrence of CDI or for long-term chronic therapy because of potential for cumulative neurotoxicity (B-II).
    11. Treatment of the second or later recurrence of CDI with vancomycin therapy using a tapered and/or pulse regimen is the preferred next strategy (B-III).
    12. No recommendations can be made regarding prevention of recurrent CDI in patients who require continued antimicrobial therapy for the underlying infection (C-III).

Definitions:

Quality of Evidence*

  1. Evidence from at least 1 properly randomized, controlled trial
  2. Evidence from at least 1 well-designed clinical trial without randomization, from cohort or case-controlled analytic studies (preferably from more than 1 center), from multiple time series, or from dramatic results from uncontrolled experiments
  3. Evidence from opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees

*Adapted from the Canadian Task Force on the Periodic Health Examination.

Strength of Recommendation*

  1. Good evidence to support a recommendation for or against use
  2. Moderate evidence to support a recommendation for or against use
  3. Poor evidence to support a recommendation

*Adapted from the Canadian Task Force on the Periodic Health Examination.

Clinical Algorithm(s)

None provided

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The type of supporting evidence is identified and graded for each recommendation (see the "Major Recommendations" field).

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Accurate diagnosis, prevention, management, and treatment of Clostridium difficile infection in adults

Potential Harms
  • Patients treated with vancomycin may be at increased risk for reinfection or prolonged carriage after treatment is stopped.
  • Use of chlorine-containing cleaning products presents health and safety concerns, as well as compatibility challenges that need to be assessed for risk.
  • Some patients report a bad taste after taking the intravenous formulation of vancomycin by mouth.
  • Metronidazole should not be used beyond the first recurrence or for long-term therapy because of the potential for cumulative neurotoxicity.
  • Caution is recommended with use of rifaximin because of the potential for isolates to develop an increased minimal inhibitory concentrations (MIC) during treatment.

Contraindications

Contraindications

It should be noted that cholestyramine, colestipol, and other anion-exchange resins bind vancomycin, which make these a specific contraindication.

Qualifying Statements

Qualifying Statements
  • The use of these guidelines can be impacted by the size of the institution and the resources, both financial and laboratory, available in the particular clinical setting.
  • It is important to realize that guidelines cannot always account for individual variation among patients. They are not intended to supplant physician judgment with respect to particular patients or special clinical situations. Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA) consider adherence to these guidelines to be voluntary, with the ultimate determination regarding their application to be made by the physician in the light of each patient’s individual circumstances.
  • The findings and conclusions in this report are those of the author(s), writing on behalf of SHEA and the IDSA, and do not necessarily represent the views of the Centers for Disease Control and Prevention, or the United States Department of Veterans Affairs.

Implementation of the Guideline

Description of Implementation Strategy

An implementation strategy was not provided.

Implementation Tools
Audit Criteria/Indicators
Foreign Language Translations
Patient Resources
For information about availability, see the Availability of Companion Documents and Patient Resources fields below.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
Getting Better
Staying Healthy
IOM Domain
Effectiveness
Patient-centeredness
Safety

Identifying Information and Availability

Bibliographic Source(s)
Cohen SH, Gerding DN, Johnson S, Kelly CP, Loo VG, McDonald LC, Pepin J, Wilcox MH. Clinical practice guidelines for Clostridium difficile infection in adults: 2010 update by the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA). Infect Control Hosp Epidemiol. 2010 May;31(5):431-55. [233 references] PubMed External Web Site Policy
Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released
2010 May
Guideline Developer(s)
Infectious Diseases Society of America - Medical Specialty Society
Society for Healthcare Epidemiology of America - Professional Association
Source(s) of Funding

Society for Healthcare Epidemiology of America (SHEA)

Infectious Diseases Society of America (IDSA)

Guideline Committee

Society for Healthcare Epidemiology and Infectious Diseases Society of America (SHEA-IDSA) Expert Panel

Composition of Group That Authored the Guideline

Panel Members: Stuart H. Cohen, MD; Dale N. Gerding, MD; Stuart Johnson, MD; Ciaran P. Kelly, MD; Vivian G. Loo, MD; L. Clifford McDonald, MD; Jacques Pepin, MD; Mark H. Wilcox, MD

Financial Disclosures/Conflicts of Interest

All members of the Expert Panel complied with the Society for Healthcare Epidemiology of America (SHEA) and Infectious Diseases Society of America (IDSA) policy on conflicts of interest, which requires disclosure of any financial or other interest that might be construed as constituting an actual, potential, or apparent conflict. Members of the Expert Panel were provided with the SHEA and IDSA conflict of interest disclosure statement and were asked to identify ties to companies developing products that might be affected by promulgation of the guideline. Information was requested regarding employment, consultancies, stock ownership, honoraria, research funding, expert testimony, and membership on company advisory boards or committees. The Expert Panel made decisions on a case-by-case basis as to whether an individual's role should be limited as a result of a conflict. No limiting conflicts were identified.

S.H.C. reports that he has served as a speaker for ViroPharma and Wyeth Pharmaceuticals and has served as a consultant to Genzyme, Salix and Romark Laboratories.

D.N.G. reports that he has served as a consultant for ViroPharma, Optimer, Genzyme, Cepheid, BD GeneOhm, Salix, Romark, Merck, Schering-Plough, Gojo, and TheraDoc; has received research support from ViroPharma, Massachusetts Biological Laboratories, Optimer, Cepheid, Gojo, Merck, and Genzyme; and holds patents for the prevention and treatment of CDI licensed to ViroPharma.

S.J. reports that he has served as an advisor to Genzyme, Viropharma, Salix Pharmaceutical, Romark Laboratories, and Acambis.

V.G.L. reports that she has served as a consultant for Genzyme.

J.P. reports that he has served on advisory boards for Pfizer and Novartis; as an advisor for Viropharma, Acambis, Wyeth Pharmaceuticals, and Bayer; and as speaker for Wyeth Pharmaceuticals.

C.P.K. reports that he has served as scientific advisor and consultant to Actelion, Cubist Pharm, MicroBiotix, Salix Pharm, Sanofi-Pasteur, ViroPharma, and Wyeth Pharm and has received research support from Actelion and MicroBiotix.

M.H.W. and L.C.M. report no conflicts relevant to this guideline.

Guideline Status

This is the current release of the guideline.

Guideline Availability

Electronic copies: Available from the Infectious Diseases Society of America (IDSA) Web site External Web Site Policy.

Print copies: Address reprint requests to Clinical Affairs, Infectious Diseases Society of America, 1300 Wilson Blvd, Suite 300, Arlington, VA 22209; E-mail: idsaguidelines@idsociety.org.

Availability of Companion Documents

Performance measures are available in the original guideline document External Web Site Policy.

Patient Resources

The following is available:

  • Frequently asked questions (FAQs) about Clostridium difficile. Patient guide. The Society for Healthcare Epidemiology of America (SHEA). 2010. 1 p. Available in Portable Document Format (PDF) from the SHEA Web site External Web Site Policy. Also available in Spanish, Arabic, and Polish translations, as well as large print format, from the SHEA Web site External Web Site Policy.

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

NGC Status

This NGC summary was completed by ECRI Institute on November 17, 2010.

Copyright Statement

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.

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