Clostridioides Difficile Infection
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Sign up freeTop drugs studied for this disease
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FDA approval · 2020-05-28FDA Approved: DIFICID — Supplemental Application (Merck Sharp & Dohme LLC)
The FDA approved a supplemental application for DIFICID (fidaxomicin) from Merck Sharp & Dohme LLC.
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FDA label_change · 2020-05-28FDA Approved: DIFICID — Supplemental Application (Merck Sharp & Dohme LLC)
The FDA approved a supplemental application for DIFICID (fidaxomicin) from Merck, updating the product labeling.
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CLINICAL_TRIALS trial_result · 2020-03-06Clinical Trial Update: Dose Ranging Study of the Safety and Efficacy of Orally Administered Lyophilized Fecal Microbiota Product (PRIM-DJ2727) for the Treatment of Recurrent Clostridium Difficile Infection (CDI) [Phase 2]
Phase 2 dose-ranging study evaluating an orally administered lyophilized fecal microbiota product for recurrent Clostridium difficile infect…
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CLINICAL_TRIALS trial_result · 2020-02-20Clinical Trial Update: Lyophilized Fecal Transplant vs Lyophilized Fecal Filtrate in Recurrent C Diff Infection [Phase 2]
Phase 2 trial update comparing lyophilized fecal transplant to lyophilized fecal filtrate for recurrent Clostridioides difficile infection h…
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CLINICAL_TRIALS withdrawal · 2020-01-27Clinical Trial Update: Prospective Trial of Oral Vancomycin Therapy vs. Placebo for Prevention of CDI [Phase 4]
Phase 4 trial investigating oral vancomycin vs placebo to prevent Clostridioides difficile infection has been withdrawn.
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FDA approval · 2020-01-24FDA Approved: DIFICID — Original Application (Merck Sharp & Dohme LLC)
FDA approved DIFICID (fidaxomicin) under an original application from Merck Sharp & Dohme LLC for the treatment of Clostridioides difficile …
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FDA approval · 2020-01-24FDA Approved: DIFICID — Supplemental Application (Merck Sharp & Dohme LLC)
FDA approved a supplemental application for DIFICID (fidaxomicin) from Merck Sharp & Dohme LLC, resulting in updated labeling under the supp…
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FDA approval · 2019-12-13FDA Approved: VANCOMYCIN HYDROCHLORIDE FOR ORAL SOLUTION — Supplemental Application (Wilshire Pharmaceuticals, Inc.)
FDA approved a supplemental application for vancomycin hydrochloride for oral solution from Wilshire Pharmaceuticals, Inc. This approval aut…
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CLINICAL_TRIALS trial_result · 2019-10-24Clinical Trial Update: FMT Delivered by Capsule Versus Colonoscopy for Recurrent C. Diff [Phase 2, Phase 3]
A comparative trial evaluating capsule-delivered fecal microbiota transplantation versus colonoscopy-delivered FMT for recurrent Clostridioi…
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CLINICAL_TRIALS trial_result · 2019-10-02Clinical Trial Update: Impact of Oral Antibiotic Treatment on C. Difficile [Phase 4]
Phase 4 clinical trial assessing the impact of oral antibiotic treatment on C. difficile outcomes; results posted after completion.
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FDA approval · 2019-06-12FDA Approved: VANCOMYCIN HYDROCHLORIDE — Original Application (Slate Run Pharmaceuticals, LLC)
FDA approved the vancomycin hydrochloride original application for Slate Run Pharmaceuticals, enabling a generic version of this antibiotic.
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CLINICAL_TRIALS trial_result · 2019-05-13Clinical Trial Update: Fresh, Frozen or Lyophilized Fecal Microbiota Transplantation for Multiple Recurrent C. Difficile Associated Diarrhea [Phase 1, Phase 2]
The document reports Phase 1 and Phase 2 results for fecal microbiota transplantation to treat recurrent Clostridioides difficile infection.
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FDA approval · 2019-04-05FDA Approved: DIFICID — Supplemental Application (Merck Sharp & Dohme LLC)
FDA approved a supplemental application for DIFICID (fidaxomicin) by Merck Sharp & Dohme LLC. The snippet does not specify the exact changes…
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CLINICAL_TRIALS trial_result · 2019-04-03Clinical Trial Update: Comparison of Cadazolid Versus Vancomycin in Children With Clostridium Difficile-associated Diarrhea (CDAD) [Phase 2, Phase 3]
Actelion-sponsored pediatric trial comparing cadazolid to vancomycin for Clostridioides difficile infection has terminated; results were pos…
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CLINICAL_TRIALS trial_result · 2019-03-25Clinical Trial Update: Fecal Microbiota Transplantation to Treat Recurrent C. Difficile Associated Diarrhea Via Retention Enema or Oral Route [Phase 1, Phase 2]
A combined Phase 1/Phase 2 clinical trial evaluating fecal microbiota transplantation via retention enema or oral route for recurrent Clostr…
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FDA approval · 2019-03-15FDA Approved: DIFICID — Supplemental Application (Merck Sharp & Dohme LLC)
FDA approves a supplemental application for DIFICID (fidaxomicin) by Merck Sharp & Dohme LLC.
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FDA approval · 2019-02-15FDA Approved: TYZAVAN — Original Application (Hikma Pharmaceuticals USA Inc.)
FDA approved TYZAVAN (vancomycin) from Hikma Pharmaceuticals USA Inc. under an Original Application (NDA211962). This marks the brand’s offi…
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CLINICAL_TRIALS trial_result · 2018-12-07Clinical Trial Update: A Study to Investigate the Safety and Efficacy of Fidaxomicin (Oral Suspension or Tablets) and Vancomycin (Oral Liquid or Capsules) in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD) [Phase 3]
This completed Phase 3 study evaluated fidaxomicin (oral suspension or tablets) versus vancomycin (oral liquid or capsules) for pediatric Cl…
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CLINICAL_TRIALS research · 2018-10-23Clinical Trial Update: Hospital Design and Risk of Nosocomial Infections: A Prospective Controlled Trial [NA]
A completed clinical trial examining hospital design and risk of nosocomial infections, with results posted in 2018, focusing on infections …
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CLINICAL_TRIALS research · 2018-07-30Clinical Trial Update: Digestive Microbiota Transplant
A digestive microbiota transplant trial update sponsored by Assistance Publique Hôpitaux de Marseille; the study status is unknown and it co…
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CLINICAL_TRIALS trial_result · 2018-07-27Clinical Trial Update: Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection [Phase 2]
Phase 2 trial results for a microbiota restoration therapy in recurrent Clostridium difficile infection have been completed and results post…
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CLINICAL_TRIALS trial_result · 2018-07-26Clinical Trial Update: SER-109 Versus Placebo to Prevent Recurrent Clostridium Difficile Infection (RCDI) [Phase 2]
Phase 2 trial SER-109 vs placebo for preventing recurrent Clostridioides difficile infection has completed, with results posted in 2018. The…
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CLINICAL_TRIALS withdrawal · 2018-07-19Clinical Trial Update: Use of Bismuth Subsalicylate in Clostridium Difficile Colitis [Phase 4]
A Phase 4 trial evaluating Bismuth Subsalicylate for Clostridioides difficile infection has been withdrawn.
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CLINICAL_TRIALS trial_result · 2018-07-18Clinical Trial Update: Study of Different Formulations of a Clostridium Difficile Toxoid Vaccine Given at Three Different Schedules in Adults [Phase 2]
The document reports the completion of a Phase 2 trial evaluating multiple formulations of a Clostridioides difficile toxoid vaccine given o…
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CLINICAL_TRIALS trial_result · 2018-07-18Clinical Trial Update: Study of a Candidate Clostridium Difficile Toxoid Vaccine in Healthy Adult Subjects Aged 40 to 75 Years in Japan [Phase 1, Phase 2]
Completion of Phase 1/Phase 2 evaluation of a candidate Clostridioides difficile toxoid vaccine in healthy adults aged 40-75 years in Japan.