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Clostridium difficile infection

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Clinical Trial Landscape

Clinical Trials for Clostridium difficile infection

30 trials tracked for Clostridium difficile infection: 14 in phase 3 or 4 and 12 with published results. The most-cited published study has 524 citations.

30Trials tracked
14Phase 3 & 4
0Recruiting
12With published results
Phase distribution
Phase 4 4 Phase 3 10 Phase 2 11 Other / NA 5
  1. Phase 3 ECOSPOR III - SER-109 Versus Placebo in the Treatment of Adults With Recurrent Clostridium Difficile Infection Completed · 524 cited
  2. Phase 3 Study of CB-183,315 in Participants With Clostridium Difficile Associated Diarrhea (MK-4261-005) Completed · 72 cited
  3. Phase 3 A Study of CB-183,315 in Participants With Clostridium Difficile Associated Diarrhea (MK-4261-006) Completed · 71 cited
  4. Phase 3 Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea Completed · 66 cited
  5. Phase 3 Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile - Associated Diarrhea Completed · 66 cited
  6. Phase 4 TOX NEG Trial: Clostridium Difficile Diagnosis and Treatment Completed · 39 cited
Show 24 more trials
  1. Phase 3 Clostridium Difficile Vaccine Efficacy Trial Completed · 35 cited
  2. Phase 3 Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH CD3-OLS) Completed · 34 cited
  3. Phase 4 Study to Assess Inhibition of Spore Production in Patients With C. Difficile Infections: Fidaxomicin Versus Vancomycin Completed · 32 cited
  4. Phase 3 A Study of MK-3415, MK-6072, and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection (MK-3415A-001) Completed · 25 cited
  5. Phase 3 A Study of MK-6072 and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection (MK-3415A-002) Completed · 18 cited
  6. Phase 3 Bezlotoxumab (MK-6072) Versus Placebo in Children With Clostridium Difficile Infection (CDI) (MK-6072-001) Completed · 12 cited
  7. Phase 4 Oral Vancomyin for Primary Clostridium Difficile Infection Prophylaxis in Patients Receiving High-Risk Antibiotics Completed
  8. Phase 4 Screening to Prophylax Against Clostridium Difficile Infection - Completed
  9. Phase 2 ICON-2: FMT and Bezlotoxumab Compared to FMT and Placebo for Patients With IBD and CDI Completed
  10. Phase 2 The GRAFT Study: Gut RecolonizAtion by Fecal Transplantation Completed
  11. Phase 2 The ICON Study: Outcomes After FMT for Patients With IBD and CDI Completed
  12. Phase 2 ACX-362E [Ibezapolstat] for Oral Treatment of Clostridioides Difficile Infection Completed
  13. Phase 2 Study of CB-183,315 in Participants With Clostridium Difficile Infection Completed
  14. Phase 2 Efficacy of Oral Vancomycin Prophylaxis for Prevention of Recurrent Clostridium Difficile Infection Completed
  15. Phase 2 Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection Completed
  16. Phase 2 Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota™ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection Completed
  17. Phase 2 Safety and Efficacy Study of VP20621 for Prevention of Recurrent Clostridium Difficile Infection Completed
  18. Phase 2 Phase 2 Study of VE303 for Prevention of Recurrent Clostridioides Difficile Infection Completed
  19. Phase 2 Vancomycin for C Difficile NAAT+/EIA- Hematology Oncology Patients Completed
  20. N/A Pulsed UV Xenon Disinfection to Prevent Resistant Healthcare Associated Infection Completed
  21. N/A COMBACTE-CDI Understanding the Burden of C. Difficile Infection Completed
  22. N/A Hospital Design and Risk of Nosocomial Infections: A Prospective Controlled Trial Completed
  23. N/A Validation of the GenePOC CDiff Assay for the Detection of the Toxin B Gene From Toxigenic Clostridium Difficile Strains Completed
  24. N/A Prospective Observational Study of Clostridium Difficile Infection in Asian Pacific Countries Completed

Showing the 30 most-cited and recently-updated of 30 trials. Browse the full registry →

Trial data sourced from ClinicalTrials.gov. Counts describe the research landscape and are not a treatment recommendation. Informational only — not medical advice.

What the trials found Updated — new results For clinicians

Clostridium difficile infection: what the trials found

Vancomycin has been evaluated across multiple trials for the treatment of Clostridium difficile infection (CDI). In one study, vancomycin was associated with a significant reduction in C. Difficile spores (at least 2 Log10 CFU/g) and vegetative cells (at least 2 Log10 CFU/g) 3. Other studies confirmed its use in various clinical settings [2, 4, 5, 16].

Several other agents have demonstrated efficacy in managing CDI. SER-109 significantly reduced the recurrence of CDI at 8 weeks (p<0.001) and across multiple subsequent time points including 4, 12, and 24 weeks (p<0.001) 6. Surotomycin showed clinical cure rates of 79.0% and 83.6% with manageable adverse event profiles 7, while CB-183,315 demonstrated clinical response rates of 83.4% and 82.1% 8.

Biological and targeted therapies have also been investigated. MK-6072 showed a statistically significant difference in CDI recurrence rates compared to other cohorts (p<0.0001) 14. Bezlotoxumab was evaluated for its impact on recurrence, though results did not reach statistical significance in the studied groups [15, 18]. RBX2660 demonstrated sustained clinical response through 6 months post-treatment in a significant number of patients 12.

Cadazolid was evaluated regarding the resolution of diarrhea and patient-reported symptom scores; however, these outcomes did not reach statistical significance (p=0.6016 and p=0.9814 respectively) [9, 10]. A large-scale study on a C. difficile vaccine reported low rates of local reactions across multiple doses 11.

Recent results — preliminary, needs further review

  • Vancomycin Oral Capsule was evaluated in a Phase 2 trial 1.

For the clinician treating this condition

  • Vancomycin is established for reducing both C. Difficile spores and vegetative cells 3.
  • SER-109 significantly reduces the rate of CDI recurrence at 8 weeks and beyond 6.
  • MK-6072 showed a statistically significant difference in recurrence rates compared to other treatments 14.
  • Surotomycin and CB-183,315 demonstrated high clinical response/cure rates [7, 8].

AI synthesis of 8 cited trials, updated Aug 4, 2026. Informational only — not medical advice; trial data sourced from ClinicalTrials.gov. How we use AI.

HCP Mode — summaries include clinical detail, trial data, and statistical outcomes.
Patient Mode — summaries use plain language, avoiding clinical jargon.
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