Phase 3 N=17,535 Clostridium Difficile Vaccine Efficacy Trial
Clostridium Difficile Infection
Primary: Number of First Primary Episodes of Clostridium Difficile Infection (CDI) (Definition 1) Follow-up After Dose 3 — 17; 25 Episodes
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Phase 3 N=27 Compassionate Use of Nitazoxanide for the Treatment of Clostridium Difficile Infection
Clostridium Enterocolitis · Pseudomembranous Colitis
Primary: Nitazoxanide — 27 participants
Phase 4 N=15 TOX NEG Trial: Clostridium Difficile Diagnosis and Treatment
Clostridium Difficile Infection · Diarrhea
Primary: Number of Participants With Detectable C. Difficile — 5; 4 Participants
N/A N=3,153 COMBACTE-CDI Understanding the Burden of C. Difficile Infection
Clostridium Difficile Infection
Primary: The Number of Cases of CDI — 103; 0 Participants
N/A N=25 Daptomycin for the Treatment of Severe Necrotizing Soft-Tissue Infections
Fasciitis, Necrotizing · Severe Necrotizing Skin and Soft Tissue Infections · Fournier's Gangrene
Primary: Clinical Response to High Dose Daptomycin Therapy at End of Treatment (EOT) — 16; 0; 2; 0 Participants
Phase 2 N=133 Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection
Enterocolitis Clostridium Difficile Recurrent
Primary: Treatment Success of Group A (2 Doses of RBX2660) vs Group B (2 Doses of Placebo) (ITT) — 25; 19; 20; 25 Participants
Phase 2 N=42 A Study To Investigate A Clostridium Difficile Vaccine In Healthy Adults Aged 50 to 85 Years, Who Will Each Receive 3 Doses Of Vaccine.
Clostridium Difficile Associated Disease
Primary: Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) — 16.7; 16.7; 50.0; 16.7 Percentage of…
Phase 1 N=24 Safety Study of Intratumoral Injection of Clostridium Novyi-NT Spores to Treat Patients With Solid Tumors That Have Not Responded to Standard Therapies
Solid Tumor Malignancies
Primary: Number of Patients With Treatment-emergent Adverse Events (TEAE) — 3; 3; 4; 6 Patients
Phase 3 N=1,994 Clostridium Difficile Vaccine 2-Dose Versus 3-Dose Study
Clostridium Difficile Associated Disease
Primary: Adjusted Geometric Mean Concentration (GMC) of Clostridium Difficile Toxin A and Toxin B Specific Neutralizing Antibodies at Month 7 for Evaluable Immunogenicity…
Phase 4 N=202 Clindamycin Once a Day in Septic Abortion
Septic Abortion
Primary: Cure (Clinical Improvement Defined as Reduce of Pain, Bleeding and no Fever for 48h) — 94.06; 86.14 percentage of cure — p=0.06
N/A N=600 Prospective Observational Study of Clostridium Difficile Infection in Asian Pacific Countries
Clostridium Difficile Infection
Primary: Patient Demographics — 54; 46; 63; 29 participants
Phase 3 N=92 Primary or Recurrent Clostridioides Difficile Infection Treatment With Capsules of Lyophilised Faecal Microbiota vs Fidaxomicin
Recurrent Clostridium Difficile Infection · Primary Clostridium Difficile Infection
Primary: Global Absence of Diarrhea Due to Clostridiodes Difficile 8 Weeks After the Start of the Treatment — 4; 9 Participants — p=0.228
Phase 3 N=1,317 Evaluation Of Clostridium Difficile Vaccine Lot Consistency In Healthy Adults 65 To 85 Years Of Age
Clostridium Difficile Associated Disease
Primary: Geometric Mean Concentrations (GMCs) of Clostridium Difficile Toxin A and Toxin B Specific Neutralizing Antibodies at Month 7 — 878.8; 873.0; 872.9; 5823.9…
Phase 2 N=200 Study of the Clinical Effectiveness of a Human Monoclonal Antibody to C. Difficile Toxin A and Toxin B in Patients With Clostridium Difficile Associated Disease
Clostridium Infections
Primary: Number of Participants With Recurrence of Clostridium Difficile Associated Disease (CDAD) — 7; 25 Participants
Phase 2 N=94 Inulin for Infections in the Intensive Care Unit
Antibiotic Resistant Infection · Nosocomial Infection · Pathogen Transmission
Primary: Within-individual Change in SCFA Producer Level — -0.0; -1.8; 1.1 percentage of SCFA producers
N/A N=189 Molecular Epidemiology of Clostridium Difficile Infections in Children
Clostridium Difficile Infections
Primary: Clostridium Difficile Infections Strain Type Based on Restriction Endonuclease Analysis — 3 cases of BI/NAP1/027
Phase 2 N=10 ACX-362E [Ibezapolstat] for Oral Treatment of Clostridioides Difficile Infection
Clostridium Difficile Infection
Primary: Segment 2A: Clinical Cure (CC) of Clostridioides Difficile Infection (CDI) Per Protocol (PP)/Modified Intent-to-Treat (mITT) Population — 10; 0 Participants
Phase 4 N=674 Screening to Prophylax Against Clostridium Difficile Infection -
Clostridium Difficile Infection
Primary: The Incidence of CDI in Inpatients Receiving Vancomycin Prophylaxis vs. Placebo Who Are on High-risk Antibiotics and Are Colonized With Toxigenic C. Difficile. — 0; 0…
Phase 2 N=272 Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection
Clostridium Difficile Infection
Primary: Number of Participants Who Were CDI-diarrhea Free Through 8 Weeks — 112; 23; 30; 52 Participants
Phase 1 N=50 Safety, Tolerability, and Immunogenicity Study of a Clostridium Difficile Toxoid Vaccine in Healthy Adult Volunteers
Clostridium Infections
Primary: Number of Participants Reporting Solicited Injection Site Erythema and Tenderness Post-vaccination With Either One of Three Formulations of Clostridium Difficile…
Phase 2 N=855 A Study To Investigate Two 3-dose Schedules Of A Clostridium Difficile Vaccine In Healthy Adults Aged 65 to 85 Years
Clostridium Difficile Associated Disease
Primary: Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 37 — 12.5; 68.4; 85.5 percentage of participants
Phase 4 N=34 Study to Assess Inhibition of Spore Production in Patients With C. Difficile Infections: Fidaxomicin Versus Vancomycin
Clostridium Difficile Infection
Primary: C. Difficile Spore Reduction of at Least 2 Log 10 Colony Forming Units (CFU)/g of Stool — 11; 6 Participants
Phase 2 N=34 Microbiota Restoration Therapy for Recurrent Clostridium Difficile-associated Diarrhea
Recurrent Clostridium Difficile Infection
Primary: Incidence of Serious Adverse Events Through 56 Days After the Last Treatment With RBX2660 — 10 number of reported SAEs through 56 days
N/A N=403 Antimicrobial Stewardship Program for Clostridium Difficile Infection.
Clostridium Difficile · Enterocolitis, Pseudomembranous
Primary: Number of Participants With Clostridium Difficile Infection Recurrence. — 34; 21 Participants — p=0.56
Phase 4 N=33 Impact of Oral Antibiotic Treatment on C. Difficile
C. Difficile · Diarrhea · Enterocolitis
Primary: Change in Total Median Total Colony Forming Units (CFU) of C. Difficile Identified in the Hospital Room Environment for Each Antibiotic Treatment Group. — 56; 33; 149; 7…
Phase 4 N=51 Oral Vancomyin for Primary Clostridium Difficile Infection Prophylaxis in Patients Receiving High-Risk Antibiotics
Clostridium Difficile Infection · Prophylaxis · Vancomycin
Primary: Clostridium Difficile Infection Occurrence — 2; 0 Participants
Phase 1 N=140 Safety and Immunogenicity Study of GSK's Clostridium Difficile Vaccine 2904545A When Administered in Healthy Adults Aged 18-45 Years and 50-70 Years
Clostridium Infections
Primary: Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose — 0; 0; 0; 8 Participants
Phase 3 N=267 Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3)
Clostridium Difficile Infection (CDI)
Primary: Efficacy of RBX2660 Compared to Placebo Through 8 Weeks — 57.5; 70.6 Model-estimated percent of participants
N/A N=10 Pharmacokinetics and Safety of Tigecycline in the Treatment of Clostridium Difficile Associated Diarrhea (CDAD)
Diarrhea · Clostridium Difficile
Primary: Pharmacokinetics of Tigecycline Along With Standard Treatments for Clostridium Difficile — 0.18 milligrams/liter
Phase 3 N=333 Ceftazidime-Avibactam for the Treatment of Infections Due to Ceftazidime Resistant Pathogens
Complicated Urinary Tract Infection · Complicated Intra-abdominal Infection
Primary: Clinical Response at Test of Cure (TOC) in Microbiological Modified Intent-to-treat (mMITT) Analysis Set — 6; 8; 129; 132 Participant