Durable Prevention of Recurrent C. Difficile Infection with RBX2660: Results of the PUNCH CD 2 Trial
Bibliographic record
Abstract
Introduction: Antibiotic treatment of C. difficile infection (CDI) with standard of care antibiotics is associated with high recurrence rates. Microbiota-based drugs have shown promise in durable prevention of CDI recurrence.1 We report on the durability of RBX2660 for the prevention of recurrent CDI in in a post-hoc analysis of PUNCH CD 2, a Phase 2b a randomized, double-blinded, placebo-controlled trial. Methods: Patients enrolled in the PUNCH CD 2 trial were randomized to receive either: 2 doses of RBX2660 (a microbiota-based drug manufactured from live human-derived microbes); 2 doses of placebo; or 1 dose of RBX2660 and 1 dose of placebo via enema with doses 7 days apart. The placebo consisted of normal saline and cryoprotectant in the same proportions found in RBX2660. Success was measured as the absence of CDI symptoms at 8 weeks post treatment. Failures in any study group were eligible to receive open-label treatment with up to 2 doses of RBX2660. Failure was defined as recurrent C. difficile-associated diarrhea; positive CDI stool test; need for retreatment for CDI; no other cause for CDI symptoms. Patients will be followed to 24 months after completing the last treatment. Results: A total of 107 patients (median age 63, range: 18-92 years; 59.8% female) at 21 centers in the U.S. and Canada received at least 1 dose of RBX2660 with an overall success rate of 88.8% (95/107). Of these patients, 4.2% (4/95) developed a new episode of CDI confirmed by a positive test > 8 weeks after the last RBX2660 treatment. One episode occurred after the patient was treated with antibiotics for a dog bite; another during a hospital stay for small bowel obstruction; and 2 were of unknown origin. The long-term CDI-free rate (median follow-up: 8.3 months; range 1.6 to 14.9 months) was 95.8% (91/95), Table 1. The median time to a new CDI episode was 135, range: 61-259 days after treatment with RBX2660.Table 1: Durability of RBX2660 TreatmentConclusion: Recurrent CDI poses on-going treatment challenges with high recurrence rates after standard antibiotic treatment. RBX2660, a microbiota-based drug, was demonstrated as an efficacious treatment for recurrent CDI with long-term durability in both open-label and randomized controlled trials. Long-term follow-up is ongoing.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".