- For patients with recurrent Clostridium difficile infections (rCDIs), 1 but not 2 doses of RBX2660, a microbiota-based drug, prevented rCDI for 8 weeks after treatment.
Why this matters
- If further research proves successful, RBX2660 may be first in a new class of treatment options for rCDIs.
- Randomized, placebo-controlled, double-blinded, multicenter trial of 127 patients with rCDI assigned to receive: 2 doses of RBX2660, each in a 150 mL suspension containing ≥107 live organisms/mL in a single-dose ready-to-use enema bag (group A), 2 doses of placebo (group B), or 1 dose of RBX2660 followed by 1 dose of placebo (group C).
- Efficacy was defined as prevention of rCDI for 8 weeks after treatment.
- The primary outcome was efficacy for group A vs group B.
- Funding: Rebiotix Inc.
- Efficacy was achieved by 61% of group A, 45% of group B, and 67% of group C, but the primary outcome was not met (group A vs B; P=.152).
- Group C (1 dose of RBX2660) had greater efficacy than group B (placebo) (P=.049).
- There was no difference among groups in adverse or serious adverse events, most commonly gastrointestinal disorders, infections, and nervous system disorders.
- Small sample size.