What is the recommended testing and treatment approach for patients suspected of having Clostridioides difficile (C. difficile) colitis?

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Last updated: September 27, 2025View editorial policy

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Testing for Clostridioides difficile Colitis

For patients suspected of having C. difficile colitis, the recommended testing approach is a two-step protocol using nucleic acid amplification tests (NAATs) or glutamate dehydrogenase (GDH) assay as the initial screen, followed by toxin A/B detection for positive initial screens. 1, 2

Patient Selection for Testing

  • Test only unformed stool samples (liquid or semi-formed stools)

  • Testing should be performed on patients with:

    • Unexplained new-onset diarrhea (≥3 unformed stools in 24 hours)
    • Hospitalization >72 hours with diarrhea, regardless of physician request 2
    • Recent healthcare facility admission within 3 months prior to diarrhea onset 2
    • Diarrhea after antibiotic exposure
    • Negative tests for other common enteropathogens 2
  • Do not test:

    • Formed stools
    • Asymptomatic patients
    • Children under 2 years (high asymptomatic colonization rates)
    • Patients who have received laxatives in the previous 48 hours

Recommended Testing Algorithms

Option 1: Two-Step Algorithm (Preferred)

  1. First step: NAAT (detecting toxin B gene) or GDH assay
  2. Second step: For positive samples, confirm with toxin A/B enzyme immunoassay (EIA)
    • If both tests positive: Confirmed CDI
    • If first test positive but toxin EIA negative: Potential colonization (clinical correlation needed)
    • If first test negative: Report as negative 2, 1

Option 2: NAAT-Only Testing

NAAT-only testing is also recommended as a best practice for detection of the C. difficile toxin gene, with high sensitivity (80-100%) and specificity (87-99%) 2, 1

Option 3: GDH/NAAT Algorithm

This algorithm is recommended for detection of C. difficile organism/toxin gene with high diagnostic accuracy (LR+ 113.5, LR- 0.09) 2

Option 4: GDH/Toxin/NAAT Algorithm

This three-step algorithm is recommended for detection of C. difficile organism, toxin, or toxin gene with moderate strength of evidence (LR+ 155.8, LR- 0.11) 2

Test Performance Characteristics

Test Sensitivity Specificity Advantages Disadvantages
GDH EIA High Moderate Excellent screening test Cannot differentiate toxigenic strains
Toxin A/B EIA 32-98% 84-100% Fast, inexpensive Variable sensitivity
NAATs 80-100% 87-99% High sensitivity, rapid May detect colonization, not infection
Toxigenic culture High High Gold standard Slow, labor-intensive

Repeat Testing Considerations

  • Repeated testing using NAAT within 7 days of a negative result has minimal additional diagnostic yield (only 3% conversion from negative to positive) 2
  • Routine repeat testing during the same episode is not recommended in endemic settings 2
  • Consider repeat testing only in epidemic situations or with high clinical suspicion despite negative initial testing 2

Additional Diagnostic Approaches

  • Imaging: CT scan may show colonic wall thickening, "accordion sign," or "double-halo sign" (sensitivity 52%, specificity 93%) 2
  • Ultrasound: May be useful in critically ill patients who cannot be transported for CT scan (shows thickened colonic wall with heterogeneous echogenicity) 2
  • Endoscopy: Flexible sigmoidoscopy may be helpful when there is high clinical suspicion but negative stool tests; use sparingly due to perforation risk in fulminant colitis 2

Treatment Initiation

  • Begin empiric therapy for suspected severe CDI while awaiting test results if strong clinical suspicion exists 2
  • Discontinue inciting antibiotics if possible 2, 1
  • For confirmed CDI, select treatment based on severity:
    • Mild-moderate: Oral vancomycin 125 mg four times daily for 10 days or metronidazole 500 mg three times daily for 10 days
    • Severe: Oral vancomycin 125 mg four times daily for 10 days
    • Fulminant: Oral vancomycin 500 mg four times daily plus IV metronidazole 500 mg three times daily 2, 1

Common Pitfalls to Avoid

  • Testing formed stools (leads to detection of asymptomatic carriers)
  • Repeat testing during the same episode (low yield, waste of resources)
  • "Test of cure" after treatment completion (not recommended)
  • Relying solely on toxin EIA without NAAT or GDH (may miss cases due to lower sensitivity)
  • Treating patients with positive tests but no diarrhea (asymptomatic colonization)
  • Delaying empiric treatment in severely ill patients while awaiting test results

The two-step testing approach balances sensitivity and specificity while minimizing detection of asymptomatic carriers, leading to more appropriate treatment decisions and improved patient outcomes.

References

Guideline

Treatment of Clostridioides difficile Infection

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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