Efficacy and Safety of RBX2660 for the Prevention of Recurrent Clostridium difficile Infection: Results. of the PUNCH CD 2 Trial
Notice bibliographique
Résumé
Background. Restoration of the intestinal microbiota is highly efficacious in preventing recurrent Clostridium difficile infection (CDI). RBX2660 is a microbiota-based drug targeted at recurrent CDI. PUNCH CD 2, a multicenter, randomized, placebo-controlled, double-blinded Phase 2b trial was conducted to evaluate the safety and efficacy of RBX2660, including questions about dosing strategy and enema administration. Methods. Patients were randomized to receive: 2 doses of RBX2660 (Group A); 2 doses of placebo (Group B); or 1 dose of RBX2660 and 1 dose of placebo (Group C) via enema with doses 7 days apart. The primary end point was treatment success following 2 doses of RBX2660 compared with 2 doses of placebo. Success was defined as the absence of Clostridium difficile–associated diarrhea at 56 days following completion of the assigned treatment. Failures could receive up to 2 doses of open-label active treatment, 7 days apart. Secondary end points included overall efficacy and safety. Safety was assessed via a patient diary and clinical assessment. Results. A total of 150 patients at 21 sites in the United States and Canada were enrolled in the study. Of these, 127 patients (Group A: n = 41; Group B: n = 44; Group C: n = 42) were in the intention-to-treat population (mean age 61 years; 62.2% female). Efficacy for Group A was 61% versus 45.5% for Group B, P = 0.152. Efficacy for Group C was 66.7% compared with Group B (45.5%), P = 0.048. Efficacy for Group A and C (63.9%) versus B (45.5%), P = 0.046. For patients who developed recurrent CDI after receipt of the study drug, open-label treatment success was: Group A (68.8%, 11/16); Group B (87.5%, 21/24); Group C (71.4%; 10/14) for an overall open-label success rate of 77.8%. The combined efficacy for all patients who received at least 1 active treatment, including those who received open label RBX2660 after initial treatment failure, was 88.8% (n = 95). Adverse events (AEs) at 56 days were primarily gastrointestinal; there were no unanticipated AEs. There was no significant difference in the proportion of adverse or serious AEs among the treatment groups. Conclusion. In patients with recurrent CDI, a single dose of RBX2660 was superior to placebo, and showed equivalent efficacy as 2 doses. RBX2660 administered via enema was safe. Disclosures. E. R. Dubberke, Rebiotix Inc.: Scientific Advisor, Consulting fee and Research support Merck: Consultant and Investigator, Consulting fee and Research grant Sanofi Pasteur: Consultant and Grant Investigator, Consulting fee and Grant recipient Summitt: Consultant, Consulting fee C. Lee, Rebiotix Inc.: Investigator and Scientific Advisor, Consulting fee and Research support R. Orenstein, Rebiotix Inc.: Investigator and Scientific Advisor, Consulting fee and Research support S. Khanna, Rebiotix Inc.: Investigator and Scientific Advisor, Consulting fee and Research support G. Hecht, Rebiotix Inc.: Investigator and Scientific Advisor, Consulting fee and Research support J. Fraiz, Rebiotix Inc.: Investigator, Research support
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,002 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».