The PUNCH CD 3 study is a Phase 3 clinical study to evaluate the safety and efficacy of Rebiotix RBX2660 for the prevention of recurrent Clostridium difficile infection (CDI).
This prospective, randomized, double-blinded, placebo-controlled clinical research study is expected to enroll up to 270 patients at 60 research sites in the U.S. and Canada. Patients that meet the study requirements and choose to enroll will be randomized to received either RBX2660, an investigational new drug, or a placebo. Two out of every three study patients will receive RBX2660, and one out of every three study patients will receive the placebo study treatment (2:1 randomization). Study patients whose CDI returns within 8 weeks after blinded study treatment may be scheduled to receive an RBX2660 treatment (no placebo). The study’s primary endpoint will compare the proportion of patients with treatment success following treatment with RBX2660 to prevent recurrent CDI within 8 weeks of blinded treament as compared to placebo.