APPENDIX 10: CLINICAL PRACTICE GUIDELINES –
RECOMMENDATIONS AND QUALITY ASSESSMENT
Table 1: Clinical Practice Guidelines – Recommendations and strength of the
evidence*
SHEA-IDSA16
Objectives
To improve the diagnosis and management of
CDI in adult patients by updating
recommendations regarding epidemiology,
diagnosis, treatment, infection control and
environmental management.
Treatment of Non-Severe Initial Episode
Metronidazole 500 mg po tid for 10 to 14 days
(A-I)
Criteria for Severe Disease
Leukocytosis with a white blood cell count
≥15,000 cells/ L
Serum creatinine level ≥ 1.5 times the premorbid
level (based on expert opinion)
A-57
ESCMID19
To evaluate the available evidence regarding the
treatment of CDI and formulate recommendations for
treatment.
If oral therapy possible:
Metronidazole 500 mg po tid for 10 days (A-I)
If oral therapy not possible:
Metronidazole 500 mg iv tid for 10 days (A-III)
CDI is judged to be severe when one or more of the
markers of severe colitis is present:
Physical examination
-fever (core body temperature >38.5°C)
-rigors (uncontrollable shaking and a feeling of cold
followed by a rise in body temperature)
-haemodynamic instability including signs of
vasodilatory or septic shock
-signs of peritonitis, including decreased bowel
sounds, abdominal tenderness, rebound tenderness
and guarding
-signs of ileus including vomiting and absent passage
of stool
Laboratory investigations
-marked leukocytosis (leukocyte count >15 X 109/L)
-marked left shift (band neutrophils >20% of
leukocytes)
-rise in serum creatinine (>50% above the baseline)
-elevated serum lactate
Colonoscopy or sigmoidoscopy
-pseudomembranous colitis
Imaging
-distension of large intestine
-colonic wall thickening including low-attenuation
mural thickening
-pericolonic fat stranding
-ascites not explained by other causes
 Table 1: Clinical Practice Guidelines – Recommendations and strength of the
evidence*
SHEA-IDSA16
Treatment of Severe Initial Episode
Vancomycin 125 mg po qid for 10 to 14 days
(B-I)
Criteria for Severe, Complicated Disease
Hypotension or shock, ileus, megacolon (based
on expert opinion)
Treatment of Severe, Complicated Initial Episode
Vancomycin 500 g qid po or by nasogastic tube
with or without metronidazole 500 mg iv every 8
h. Consider adding rectal installation of
vancomycin 500 mg in 100 mL ns every 6 h in
cases of complete ileus (C-III)
Treatment of first recurrent episode
Same as initial episode (A-II) but should be
stratified based on disease severity (C-III)
Treatment of subsequent recurrent episodes
Vancomycin in a tapered and/or pulsed regimen
(B-III)
Other Recommendations
Metronidazole is not recommended beyond the
first recurrence or for long-term chronic therapy
due to cumulative neurotoxicity (B-II)
ESCMID19
It is unclear whether moderate disease in a patient
with other unfavourable prognostic factors such as
advanced age (≥65 years), comorbidity, ICU
admission, and immunodeficiency should be regarded
as severe.
If oral therapy possible:
Vancomycin 125 mg po qid for 10 days (A-I)
If oral therapy not possible:
Metronidazole 500 mg iv tid for 10 days (A-III) +
intracolonic vancomycin 500 mg in 100 mL of ns
every 4 to 12 h (C-III) and/ or vancomycin 500 mg
qid by nasogastric tube (C-III)
NR
NR
Treat a first recurrence as a first episode, unless the
disease has progressed from non-severe to severe
(not rated for strength)
If oral therapy is possible:
Vancomycin 125 mg po qid for 10 days (B-II)
Consider a taper strategy (decreasing daily dose by
125 mg every 3 days) or a pulse strategy (a dose of
125 mg every 3 days for 3 weeks) (B-II)
If oral therapy is not possible:
Metronidazole 500 mg iv tid for 10 to 14 days (A-III)
+ retention enema of vancomycin 500 mg in 100 mL
of ns every 4 to 12 h (C-III) and/or vancomycin 500
mg qid by nasogastric tube (C-III)
In all of the above cases, vacomycin may be replaced
by teicoplanin 100 mg bid (not available in Canada)
(not rated for strength)
A-58
 Table 1: Clinical Practice Guidelines – Recommendations and strength of the
evidence*
SHEA-IDSA16 ESCMID19

There is no evidence that various genotypes of C.

difficile should be treated differently if disease
severity does not differ.
bid= twice daily; CDI= C. difficile infection; ESCMID= European Society of Clinical Microbiology and
Infectious Diseases; h= hour; iv= intravenous; NR= not reported; ns= normal saline; po= orally; qid= four
times daily; SHEA-IDSA= Society for Healthcare Epidemiology of America-Infectious Diseases Society
of America; tid= three times daily

*according to the Canadian Task Force on Preventative Health Care

Strength of recommendation
A: Good evidence to support a recommendation
B: Moderate evidence to support a recommendation
C: Poor evidence to support a recommendation

Quality of the Evidence

I: Evidence from ≥ one properly randomized controlled trial
II: Evidence from ≥ one well-designed clinical trial, without randomization; from cohort or case-
controlled analytic studies (preferably from more than one centre); from multiple time-series; or from
dramatic results from uncontrolled experiments
III: Evidence from opinions of respected authorities, based on clinical experience, descriptive studies, or
reports of expert committees

Table 2: AGREE104 scores – ESCMID guidelines

Criteria Standardized domain score*
SHEA-IDSA16 ESCMID19
Scope and purpose
The overall objective(s) of the guideline is (are) specifically
described
The clinical question(s) covered by the guideline is(are) 83.3% 22.2%
specifically described
The patients to whom the guideline is meant to apply are
specifically described
Stakeholder involvement
The guideline development group includes individuals from all the
relevant professional groups
The patients’ views and preferences have been sought 4.2% 20.8%
The target users of the guideline are clearly defined
The guideline has been piloted among target users
Rigor of development
Systematic methods were used to search for evidence
The criteria for selecting the evidence are clearly described
The methods used for formulating the recommendations are clearly
64.3% 50.0%
described
The health benefits, side effects, and risks have been considered in
formulating the recommendations

A-59