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Clostridioides difficile Infection, Including Pseudomembranous Colitis

Chapter 139 | Part 5: Infectious Diseases · Part 5 – Infectious Diseases: Bacterial · Chapter 139


Key Clinical Points

  1. CDI is the most common healthcare-associated infection in the US (462,100 cases in 2017).
  2. Diagnosis requires diarrhea (≥3 unformed stools/24h for ≥2 days) plus detection of toxin A/B or toxigenic C. difficile.
  3. First-line treatment: Fidaxomicin (200 mg bid imes 10d) or Vancomycin (125 mg qid imes 10d).
  4. Metronidazole is recommended only for mild/moderate CDI if vancomycin/fidaxomicin unavailable.
  5. Fulminant CDI: Vancomycin (PO/NG) + Metronidazole (IV) + Rectal Vancomycin enema.
  6. Recurrent CDI: Fidaxomicin, Vancomycin taper-and-pulse, Rifaximin, or FMT.
  7. Bezlotoxumab reduces recurrent CDI risk in high-risk patients (>65 years, immunocompromised).
  8. Asymptomatic testing and 'tests of cure' are not recommended (50% remain colonized post-diarrhea).
  9. NAP1/BI/027 strain produces 16–23 imes more toxin and carries binary toxin CDT.
  10. Adynamic ileus with unexplained leukocytosis (≥15,000 WBC/μL) suggests unsuspected CDI.

1. DEFINITION & OVERVIEW

Definition: Colonic infection acquired via antimicrobial use, disrupting normal microbiota.

Key Features: ◦ Acquired in healthcare settings; most common hospital-acquired diarrheal illness. ◦ Caused by ingestion of C. difficile spores that germinate and secrete toxins (A/B) after microbiota disruption. ◦ Pseudomembranous colitis (PMC) is advanced CDI visible at endoscopy in \sim50% of cases with positive stool tests.

1.1 Microbiology & Classification

C. difficile: Obligate anaerobe, gram-positive spore-forming bacillus. ◦ Spores persist on environmental surfaces and healthcare workers' hands. ◦ NAP1/BI/027 strain: Epidemic strain with 16–23 imes higher toxin production, binary toxin CDT, and fluoroquinolone resistance.

1.2 Toxin Production & Pathogenesis

Toxigenic strains produce: ◦ Toxin A (enterotoxin) and Toxin B (cytotoxin): glucosylate Rho family GTPases, disrupting actin cytoskeleton. ◦ Binary toxin CDT: present in NAP1/BI/027 strain. ◦ Toxin B may be primary virulence factor (based on studies of isogenic mutants).


2. EPIDEMIOLOGY

Trends: 462,100 US cases in 2017; 24% decrease (2011–2017) due to reduced healthcare-associated infections. • Community Spread: Community-associated rates now match healthcare-associated rates. • Historical Context: Epidemic NAP1/BI/027 strain drove early 2000s incidence surge.

2.1 Risk Factors

Primary Driver: Antimicrobial use. ◦ Age >65 ◦ Prolonged hospitalization (>2 weeks: fecal colonization ≥20%). ◦ Gastrointestinal surgery, enteral feeding, proton pump inhibitors.

2.2 Strain Epidemiology

NAP1/BI/027: Epidemic strain with 16–23 imes higher toxin production and binary toxin CDT. • Ribotype 106: (UK origin) currently the most common community-associated strain in the US.


3. ETIOLOGY & PATHOPHYSIOLOGY

Three essential events for CDI development: 1. Antimicrobial exposure → microbiota disruption. 2. Toxigenic C. difficile colonization. 3. Virulent strain, specific antimicrobials, or inadequate host immunity.

3.1 Host Immunity

Immune Response: ◦ Serum IgG to toxin A/B correlates with protection against recurrence. ◦ Monoclonal antibodies (toxin A+B) reduce recurrence rates in trials. ◦ Antibody to toxin A alone is ineffective.


4. CLINICAL FEATURES

General Manifestations: ◦ Diarrhea: soft/unformed/watery, non-bloody, characteristic odor. ◦ Systemic signs: Fever (28%), abdominal pain (22%), leukocytosis (50%). ◦ Adynamic ileus (20% of cases): May mask CDI with unexplained leukocytosis (≥15,000 WBC/μL).

4.1 Pseudomembranous Colitis (PMC)

Pathology: Whitish-yellow plaques (1–2 mm) progressing to confluent pseudomembranes. ◦ Microscopy: necrotic leukocytes, fibrin, mucus, eroded epithelium with neutrophil infiltration. ◦ Note: 10% of cases have rectal sparing (see Figure 139-1).

4.2 Fulminant CDI

Severe Presentation: Mimics acute surgical abdomen (ileus, toxic megacolon). ◦ Sepsis signs: hypotension, fever, tachycardia, leukocytosis (≥20,000 WBC/μL). ◦ Diagnostic Challenge: May occur when no diarrhea is present.


5. DIFFERENTIAL DIAGNOSIS

Clinical Context: Consider CDI in acute abdomen or sepsis cases with recent antimicrobial use (past 2 months). ◦ Note: Adynamic ileus may obscure diagnosis.


6. INVESTIGATIONS & DIAGNOSIS

  1. Clinical Presentation: Identify diarrhea ≥3 unformed stools/24h for ≥2 days.
  2. Laboratory Testing (Table 1): ◦ Stool culture: Most sensitive (++++); specificity of ++++ if the C. difficile isolate tests positive for toxin; turnaround time too slow for practical use. ◦ Cell culture cytotoxin test on stool: High specificity (++++), sensitivity (+++). ◦ Toxin EIA (A/B): Rapid results, but less sensitive than stool culture or cell culture cytotoxin test (sensitivity ++ to +++; specificity +++). ◦ GDH assay: More sensitive than toxin EIA (sensitivity +++ to ++++); requires confirmation. ◦ NAAT (PCR) for toxin A or B gene: Widely used in US; more sensitive than enzyme immunoassay; marked increase in CDI diagnoses when implemented (sensitivity ++++; specificity +++).
  3. Endoscopy: Rapid tool for suspected PMC; note that negative results do not exclude CDI.

6.1 Diagnostic Test Summary

Table 1 — Relative Sensitivity and Specificity of Diagnostic Tests for Clostridioides difficile Infection (CDI)

TYPE OF TEST RELATIVE SENSITIVITY RELATIVE SPECIFICITY COMMENT
Stool culture for C. difficile ++++ +++ Most sensitive test; specificity of ++++ if toxin-positive; slow turnaround
Cell culture cytotoxin test on stool +++ ++++ High specificity but not as sensitive as culture; slow turnaround
Enzyme immunoassay for toxins A and B in stool ++ to +++ +++ Rapid results, less sensitive than culture or cell culture cytotoxin test
Enzyme immunoassay for C. difficile common antigen (GDH) +++ to ++++ +++ More sensitive than toxin EIA; requires confirmation
Nucleic acid amplification tests (NAAT) ++++ +++ Widely used in US; more sensitive than EIA; increased diagnoses when implemented
Colonoscopy/sigmoidoscopy + ++++ Highly specific if pseudomembranes seen

7. MANAGEMENT & TREATMENT

  1. Initial Actions: Discontinue antimicrobials if possible (15–23% respond).
  2. Primary Treatment (Table 2): ◦ Mild/Moderate: Fidaxomicin (200 mg bid imes 10d) OR Vancomycin (125 mg qid imes 10d). ◦ Severe: Fidaxomicin (200 mg bid imes 10d) OR Vancomycin (125 mg qid imes 10d). ◦ Metronidazole: Only if vancomycin/fidaxomicin unavailable; dose 500 mg tid imes 10–14 d.
  3. Fulminant CDI Treatment: ◦ Vancomycin (500 mg PO or via nasogastric tube) ◦ Metronidazole (500 mg IV q8h) ◦ Rectal instillation of vancomycin (500 mg in 100 mL of normal saline as a retention enema q6–8h).
  4. Recurrent CDI Management: ◦ Fidaxomicin (200 mg bid imes 10d OR 200 mg bid imes 5d followed by every other day imes 20 d). ◦ Vancomycin taper-and-pulse regimen. ◦ Rifaximin (400 mg bid imes 2 weeks). ◦ Fecal microbiota replacement therapy (FMRT) (Rebyota, Vowst) after appropriate antibiotic treatment.
  5. Adjunctive Therapy: ◦ Bezlotoxumab (10 mg/kg IV) for high-risk patients (age >65, immunocompromised, severe CDI).

7.1 Treatment Regimens

Table 2 — Recommendations for the Treatment of Clostridioides difficile Infection (CDI)

CLINICAL SETTING TREATMENT(S) COMMENTS
Initial episode, mild to moderate Fidaxomicin (200 mg bid imes 10 d) or alternatively Oral vancomycin (125 mg qid imes 10 d) Metronidazole is less effective; use only if vancomycin/fidaxomicin not available.
Initial episode, severe Vancomycin (125 mg qid imes 10 d) or Fidaxomicin (200 mg bid imes 10 d)
Fulminant Vancomycin (500 mg PO/NG) + Metronidazole (500 mg IV q8h) + Rectal vancomycin enema (500 mg in 100 mL NS, q6–8h) Defined as severe CDI with hypotension, shock, ileus, or toxic megacolon. Duration may be >2 weeks.
Multiple recurrences Vancomycin taper-and-pulse; Fidaxomicin (200 mg bid imes 10d OR 200 mg bid imes 5d followed by every other day imes 20 d); Rifaximin (400 mg bid imes 2 weeks); FMRT FMRT (Rebyota, Vowst) only after appropriate antibiotic treatment.
Adjunctive Bezlotoxumab 10 mg/kg given IV For high-risk patients.

8. PROGNOSIS & COMPLICATIONS

Recurrence: 15–30% of treated patients experience recurrence. ◦ Recurrent CDI carries 11% risk of serious complications (shock, megacolon, perforation, colectomy, death within 30 days). • Surgical Intervention: Surgical colectomy for refractory cases of fulminant CDI.


9. SPECIAL CONSIDERATIONS

Proton Pump Inhibitors: Modest risk factor if not on antibiotics. • Neonatal: Common colonization but disease is rare. • FMT: Now FDA-approved (Rebyota/Vowst) for recurrent CDI.


10. KEY PEARLS & CLINICAL TRAPS

Avoid 'tests of cure': Not predictive of recurrence; 50% remain colonized post-diarrhea. • Clinical Trap: Adynamic ileus + leukocytosis (≥15,000 WBC/μL) → suspect CDI. • Surgical Mimic: Fulminant CDI may present without diarrhea (mimics surgical abdomen).


Reference Tables

TABLE 139-1 Relative Sensitivity and Specificity of Diagnostic Tests for Clostridioides difficile Infection

Harrison's 22e, p.1084

TYPE OF TEST RELATIVE SENSITIVITYa RELATIVE SPECIFICITYa COMMENT
Stool culture for C. difficile ++++ +++ Most sensitive test; specificity of ++++ if the C. difficile isolate tests
positive for toxin; turnaround time too slow for practical use
+++ ++++
Enzyme immunoassay for toxins A and
B in stool
++ to +++ +++ With clinical data, is diagnostic of CDI; rapid results, but not as sensitive
as stool culture or cell culture cytotoxin test
+++ to ++++ +++
Nucleic acid amplification tests for
C. difficile toxin A or B gene in stool
++++ +++ Detects toxigenic C. difficile in stool; widely used in United States for
clinical testing; more sensitive than enzyme immunoassay toxin testing;
marked increase in CDI diagnoses when implemented
+ ++++

TABLE 139-2 Recommendations for the Treatment of Clostridioides difficile Infection

Harrison's 22e, p.1085

CLINICAL SETTING TREATMENT(S) COMMENTS
Initial episode, mild to
moderate
Fidaxomicin (200 mg bid × 10 d) or alternatively
Oral vancomycin (125 mg qid × 10 d)
Oral metronidazole is less effective than the other options and may
necessitate a longer treatment course for response. Metronidazole
(500 mg tid × 10–14 d) is recommended only if vancomycin or fidaxomicin
is not readily accessible and for mild to moderate disease only.
Oral vancomycin (125 mg qid × 10 d) or alternatively
Fidaxomicin (200 mg bid × 10 d)
Initial episode, fulminant Vancomycin (500 mg PO or via nasogastric tube) plus
metronidazole (500 mg IV q8h) plus consider
Rectal instillation of vancomycin (500 mg in 100 mL of normal
saline as a retention enema q6–8h)
Fulminant CDI is defined as severe CDI with the addition of hypotension,
shock, ileus, or toxic megacolon. The duration of treatment may need to
be >2 weeks and is dictated by response.
Fidaxomicin (200 mg bid × 10 d) or
Oral vancomycin (125 mg qid × 10 d) or
Oral vancomycin followed by a taper-and-pulse regimena
Multiple recurrences Oral vancomycin treatment followed by a taper-and-pulse
regimen or
Fidaxomicin (200 mg bid × 10 d or 200 mg bid × 5 d followed by
every other day × 20 d) or
Vancomycin (125 mg qid × 10 d), then stop vancomycin and
start rifaximin (400 mg bid × 2 weeks) or
Fecal microbiota replacement therapy (FMRT)
It is recommended that FMRT by fecal microbiota (Rebyota, live-jslm)
given by enema or fecal microbiota spores (Vowst, live-brpk) given orally
be considered only after appropriate antibiotic treatment for recurrent
CDI.
Bezlotoxumab 10 mg/kg given IV