Clinical trials: CDI
Clostridium Difficile, Clostridium Difficile Infections
VE303 for Prevention of Recurrent Clostridioides Difficile Infection
The overall objective of the RESTORATiVE303 study is to evaluate the safety and the Clostridioides difficile infection (CDI) recurrence rate at Week 8 in participants who receive a 14-day course of VE303 or matching placebo.
- Conditions
- Clostridium Difficile, Clostridium Difficile Infections, Clostridium Difficile Infection Recurrence, Clostridioides Difficile Infection
- Trial name
- RESTORATiVE303 (NCT06237452)
- Testing
- VE303
- Where
- 215 sites in United States, Australia and 22 more
- Volunteers
- 852 people
- Sponsor
- Vedanta Biosciences, Inc.
Central Diabetes Insipidus (cDI)
Oxytocin Substitution Therapy in Patients With Central Diabetes Insipidus
This randomized, placebo-controlled, double-blind trial aims to investigate intranasal OXT as a novel therapeutical option in central diabetes insipidus (cDI) to improve psychological symptoms and socio-emotional functioning.
- Trial name
- OxyTUTION (NCT06036004)
- Testing
- Intranasal OXT
- Where
- 3 sites in Germany, Netherlands and 1 more
- Volunteers
- 112 people
- Sponsor
- University Hospital, Basel, Switzerland
Acute Graft-Versus-Host Reaction Following Bone Marrow Transplant, Prevention of CDI in Adult Patients Being Treated With IV Beta-lactam Antibiotics
SYN-004 Safety and Tolerability in Allo-HCT Subjects
Study Objectives: 1. To evaluate the safety and tolerability of oral SYN-004 in adult allogeneic HCT (allo-HCT) recipients who develop fever after conditioning therapy and are treated with IV β-lactam antibiotics meropenem (MER)…
- Trial name
- NCT04692181
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Theriva Biologics, Inc.
Clostridium Difficile Infection (CDI)
Study of Metronidazole Delayed-Release Capsules in Comparison With Immediate-Release Tablets (Flagyl) for Safety and Pharmacokinetics
Clostridium difficile Infection (CDI) also referred to as Clostridium difficile associated diarrhea (CDAD) is an infectious disease that is commonly associated with taking broad-spectrum antimicrobials and certain cancer…
- Trial name
- NCT07251127
- Testing
- Delayed-release metronidazole, Immediate-release metronidazole
- Where
- India
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Gateway Pharmaceutical LLC
Clostridioides Difficile Infection, Clostridioides Difficile Infection Recurrence
STOP-CDI: Efficacy of Fecal Microbiota Transplantation vs Fidaxomicin vs Vancomycin in Treating and Preventing Relapse of Clostridioides Difficile Infection
The STOP-CDI study is a multicenter, randomized, open-label, three-arm clinical trial comparing the efficacy of fecal microbiota transplantation (FMT) preceded by vancomycin, fidaxomicin monotherapy, and standard-of-care…
- Conditions
- Clostridioides Difficile Infection, Clostridioides Difficile Infection Recurrence, Fecal Microbiota Transplantation (FMT), Comparative Effectiveness of CDI Treatments
- Trial name
- STOP-CDI (NCT07120490)
- Testing
- FMT (fecal microbiota transplantation), Fidaxomicin, Vancomycin (VAN) treatment
- Volunteers
- 424 people
- Sponsor
- Medical University of Warsaw
Clostridium Difficile, Clostridium Difficile Infection
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Clostridoides Difficile Infection
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.
- Conditions
- Clostridium Difficile, Clostridium Difficile Infection, Microbiome, CDI
- Trial name
- NCT04100603
- Testing
- No Intervention
- Where
- United States
- Sponsor
- ProgenaBiome
Recurrent Clostridium Difficile Infection, Clostridium Difficile Infection
Efficacy of Oral Vancomycin Prophylaxis for Prevention of Recurrent Clostridium Difficile Infection
This study evaluates the efficacy of prophylaxis with oral vancomycin for preventing recurrent Clostridium difficile Infection (CDI) in patients who have experienced at least one CDI episode in the last 180 days and are receiving…
- Conditions
- Recurrent Clostridium Difficile Infection, Clostridium Difficile Infection, CDI, C.Difficile Diarrhea
- Trial name
- NCT03462459
- Testing
- Vancomycin
- Where
- 2 sites in United States
- Volunteers
- 79 people
- Sponsor
- University of Wisconsin, Madison
Inflammatory Bowel Disease (IBD), Clostridium Difficile Infection (CDI)
Study to Evaluate the Pharmacokinetics of Fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects With Clostridium Difficile Infection (CDI)
The purpose of this study is to investigate the plasma pharmacokinetics (PK) of fidaxomicin (FDX) and primary metabolite OP-1118 in Subjects with Inflammatory Bowel Disease (IBD) and C. difficile Infection (CDI).
- Trial name
- PROFILE (NCT02437591)
- Testing
- fidaxomicin
- Where
- 12 sites in Austria, France and 5 more
- Volunteers
- 25 people
- Sponsor
- Astellas Pharma Europe Ltd.
CDI
Evaluation of Gut Microbiota and Its Associated Resistome in FMT Donors and Recipients Due to Recurrent Clostridiodes Difficile Infection
Caratterizzazione della composizione microbica intestinale nei donatori di FMT e nei pazienti affetti da rCDI al tempo basale e a seguito del trapianto di microbiota fecale.
- Trial name
- MICROFMT (NCT06533800)
- Volunteers
- 24 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Clostridium Difficile Infection (CDI)
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3)
This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3 study of a microbiota suspension of intestinal microbes.
- Trial name
- NCT03244644
- Testing
- RBX2660, Open label RBX2660 (only for confirmed CDI recurrence)
- Where
- 66 sites in United States, Canada
- Volunteers
- 320 people
- Sponsor
- Rebiotix Inc.
Clostridium Difficile Infection (CDI)
Evaluation of Fidaxomicin in the Treatment of Clostridium Difficile Infection (CDI)
This is a single center collection of discarded biological samples and electronic medical review (EMR) data on patients who are hospitalized with clostridium difficile infections and treated with Fidaxomicin
- Trial name
- NCT04070352
- Testing
- Fidaxomicin
- Where
- United States
- Sponsor
- University of Pittsburgh
Clostridium Difficile Infection Recurrence, Clostridium Difficile Infection
Phase 2 Study of VE303 for Prevention of Recurrent Clostridioides Difficile Infection
This study evaluated the safety and efficacy of VE303 for participants with primary C. difficile infection (pCDI) at high risk for recurrence or subjects with recurrent C. difficile infections (rCDI).
- Conditions
- Clostridium Difficile Infection Recurrence, Clostridium Difficile Infection, Clostridium Difficile, Clostridioides Difficile Infection Recurrence
- Trial name
- CONSORTIUM (NCT03788434)
- Testing
- VE303
- Where
- 37 sites in United States, Canada
- Volunteers
- 79 people
- Sponsor
- Vedanta Biosciences, Inc.
Clostridium Difficile Infection (CDI)
Treatment of Mild-moderate Clostridium Difficile Infection (CDI)
Patients diagnosed to have mild-moderate CDI will be randomized to receive IM-01 egg-derived anti-C. difficile polyclonal antibodies in increasing dosages, twice daily, for a total of 10 - 14 days.
- Trial name
- IM-01 (NCT04121169)
- Testing
- IM-01
- Where
- Canada
- Volunteers
- 60 people
- Sponsor
- ImmuniMed Inc.
Clostridium Difficile Infection, Recurrent Clostridium Difficile Infection
Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota™ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection
This is an open-label study evaluating the safety and efficacy of CP101 treatment in 1) Subjects in CDI-001 who had a CDI recurrence within 8 weeks of receiving CP101 or placebo; OR 2) adults with recurrent CDI who are eligible…
- Conditions
- Clostridium Difficile Infection, Recurrent Clostridium Difficile Infection, C. Diff, CDI
- Trial name
- PRISM-EXT (NCT03497806)
- Testing
- CP101
- Where
- 57 sites in United States, Canada
- Volunteers
- 132 people
- Sponsor
- Finch Research and Development LLC.
CDI
Precision Antimicrobial STewardship for Clostridioides DIfficile Prevention
To decrease CDI incidence by implementing an electronic health record-integrated CDI-risk classification tool for Clostridioides difficile infection (CDI) to focus a bundle of antimicrobial stewardship (AMS) CDI prevention…
- Trial name
- PASTCDI (NCT05508607)
- Testing
- CDI-risk Classification Tool
- Where
- United States
- Volunteers
- 13,319 people
- Sponsor
- Intermountain Health Care, Inc.
Clostridium Difficile Infection (CDI)
A Comparison of Fidaxomicin and Vancomycin in Patients With CDI Receiving Antibiotics for Concurrent Infections
Administration of concomitant antibiotics (CA) is a known risk factor for treatment failure in the treatment of CDI, as well as for recurrence of CDI.
- Trial name
- NCT02692651
- Testing
- Fidaxomicin, Vancomycin
- Where
- 2 sites in United States
- Volunteers
- 144 people
- Sponsor
- University of Michigan
Clostridium Difficile Infection, C.Difficile Diarrhea
The GRAFT Study: Gut RecolonizAtion by Fecal Transplantation
The primary objective of this study is to compare the gut microbiota and clinical outcomes of oral FMT during antibiotic treatment, immediately following antibiotic treatment, and placebo.
- Conditions
- Clostridium Difficile Infection, C.Difficile Diarrhea, CDI
- Trial name
- GRAFT (NCT03621657)
- Testing
- Low Dose FMT Capsule DE, Single Dose FMT Capsule DE
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- University of Wisconsin, Madison
CDI
Prospective Trial of Oral Vancomycin Therapy vs. Placebo for Prevention of CDI
The purpose of this research study is to determine in patients receiving intravenous (IV) antibiotic(s), if giving oral vancomycin therapy will prevent C. difficile-associated infection (commonly called CDI).
- Trial name
- NCT04241744
- Testing
- Vancomycin 125 MG po BID
- Where
- United States
- Sponsor
- Creighton University