Secondary Prophylaxis of Recurrent Clostridioides difficile Infections During Systemic Antibiotics with Vancomycin...

Area of Science:

• Infectious Diseases
• Clinical Trials
• Pharmacology

Background:

• Clostridioides difficile infection (CDI) frequently recurs (approx. 25%) despite treatment.
• Re-exposure to systemic antibiotics is a major risk factor for CDI recurrence.
• Existing evidence on secondary vancomycin prophylaxis for preventing recurrent CDI is inconclusive.

Purpose of the Study:

• To evaluate the efficacy and safety of secondary vancomycin prophylaxis in preventing recurrent CDI.
• To determine if prophylactic oral vancomycin reduces CDI recurrence in patients re-exposed to systemic antibiotics.
• To provide high-quality evidence for clinical decision-making regarding CDI recurrence prevention.

Main Methods:

• Phase III, double-blind, randomized controlled trial (SPORES-V).
• Patients with recent CDI re-exposed to antibiotics randomized to oral vancomycin or placebo.
• Primary outcome: CDI recurrence at 56 days; secondary outcomes: adverse events, longer-term recurrence, healthcare usage, mortality.

Main Results:

• Data collection and analysis are ongoing as the trial has begun recruitment.
• Primary and secondary outcome data will be analyzed using intention-to-treat principles.
• The trial is registered on ClinicalTrials.gov (NCT06979609).

Conclusions:

• The SPORES-V trial is designed to yield definitive evidence on vancomycin prophylaxis for recurrent CDI.
• Results will clarify the role of secondary vancomycin prophylaxis in managing patients at risk of CDI recurrence.
• The study will inform clinical guidelines for preventing CDI recurrence.