668. Quality of Life Changes in Patients with Clostridium difficile Infection (CDI): A Randomized, Double-Blind Trial of Ridinilazole (RDZ) Compared with Vancomycin (VAN)

Abstract

Background C. difficile is the most frequent hospital-acquired bacteria in the United States. CDI is associated with significant morbidity and mortality, and a 46% lower mean EQ-5D index of Health-Related Quality of Life (HRQoL) compared with the general population. However, data on the impact of antibiotic treatment for CDI on HRQoL are lacking.MethodsRDZ is a novel, narrow-spectrum antibiotic with targeted activity against C. difficile, under development for the treatment of CDI and prevention of recurrence. We evaluated HRQoL prospectively with the EQ-5D-3L in 69 patients enrolled in a Phase 2 randomized, double-blind trial comparing RDZ (n = 36) with VAN (n = 33). EQ-5D-3L was obtained at five time points (baseline, days 5, 10, 12, and 40) with summary index values calculated using US weights (Shaw 2005) evaluating raw scores for mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and visual analog scale (VAS) scores.ResultsAs early as Day 5, CDI patients on RDZ had significant improvements in mean change from baseline in index scores (P = 0.008) and VAS scores (P = 0.01) but no significant improvements were seen in patients on VAN. Time to resolution of diarrhea also occurred sooner with RDZ with a hazard ratio 1.19 in favor of RDZ (90% CI: 0.76, 1.87). Mean changes in index scores in the VAN group took longer to improve significantly compared with baseline and became higher on VAN on Day 12 and Day 40. Treatment-related improvements in pain/discomfort and anxiety/depression are shown in Figures 1 and 2. The mean change from baseline in EQ-5D-3L domains showed the highest (significant) improvements in the pain/discomfort domain for both treatment groups across all time points. However, by Day 40, anxiety/depression improved significantly more with RDZ than with VAN (P = 0.039).ConclusionWe believe this is the first study to document improvements in HRQoL after antimicrobial treatment for CDI. Patients receiving ridinilazole experienced greater improvements in HRQoL sooner than those on VAN. Anxiety/depression and pain/discomfort improved significantly with treatment. HRQoL should be evaluated in Phase 3 interventional studies for CDI. These results will need to be validated in the ongoing Phase 3 randomized, double-blind, global trials comparing RDZ to VAN for the treatment of CDI. Disclosures All authors: No reported disclosures.