Clostridioides difficile infection is associated with morbidity and mortality and can recur following initial treatment. Among patients with a first episode or first recurrence of infection, a 4-week vancomycin pulse-and-taper regimen had a 74% probability of being superior to a 2-week pulse regimen followed by placebo taper in preventing recurrence, according to results from the parallel-design, double-blind TAPER-V trial published in JAMA Network Open by Emily G. McDonald, MD, of McGill University, Montréal, and colleagues.

The researchers acknowledged that this difference, observed at day 56, “may have simply been due to delayed recurrences.” Nevertheless, they stated, “This approach may represent a safe and accessible treatment option to delay or prevent early C difficile infection recurrence.”

About TAPER-V

The TAPER-V trial was conducted at 12 Canadian hospitals and enrolled adult patients with a first episode or first recurrence of C difficile infection who had laboratory-confirmed disease and clinical improvement by day 10 of treatment.

A total of 265 patients (median age = 63 years; 52% women) received a 2-week pulse of oral vancomycin (125 mg four times daily at the time of recruitment) and were then randomly assigned to either a vancomycin taper regimen (125 mg twice daily for 7 days, then once daily for 7 days; n = 135) or matching placebo (n = 130).

The primary outcome was the posterior probability of superiority of the pulse-and-taper regimen in preventing recurrence at day 56; recurrence at day 38 was a secondary outcome.

The trial was stopped early because of recruitment feasibility challenges.

Recurrence Rates

By day 56, recurrence occurred in 15% of patients in the vancomycin pulse-and-taper group vs 18% of those who received pulse therapy followed by placebo taper. Recurrence by day 38 was observed in 7% and 15% of the groups, respectively.

Adverse effects were uncommon with both approaches, the researchers wrote.

“Further pragmatic randomized evidence will be essential to optimizing therapy for C difficile infection, particularly a head-to-head clinical trial of a vancomycin pulse-and-taper regimen vs fidaxomicin with longer-term follow-up,” the researchers concluded.

Disclosure: For full disclosures of the researchers, visit jamanetwork.com.

Source: JAMA Network Open