Clinical trials: Clostridium Infections
Clostridium Infections
Safety and Immunogenicity Study of GSK's Clostridium Difficile Vaccine 2904545A When Administered in Healthy Adults Aged 18-45 Years and 50-70 Years
The purpose of this study is to generate safety, reactogenicity (assessment of any expected or unexpected side effect of the vaccine) and immunogenicity (ability to induce an immune response) data for the development of a…
- Trial name
- NCT04026009
- Testing
- C. difficile investigational vaccine based on the F2 antigen (GSK2904545A), C. difficile investigational vaccine based on the F2 antigen (GSK2904545A) adjuvanted with AS01B
- Where
- Belgium
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Clostridium Difficile
Fecal Microbiota Transplant (FMT) Plus Fidaxomicin for Severe or Fulminant Clostridium Difficile Infection
Fecal microbiota transplantation (FMT) has been very effective for patients who suffer from mild C diff infection (CDI) which recurs but it is unclear how effective FMT alone is in treating severe and fulminant CDI.
- Trial name
- NCT03760484
- Testing
- Fidaxomicin 200 mg, fecal microbiota transplantation (FMT)
- Where
- Canada
- Volunteers
- 4 people
- Sponsor
- University of Alberta
Antibiotic Enterocolitis
Effect of Antibiotics on Enteric Neurons and Glia
The interactions between bacteria and their products with the intestinal tissue are important for maintaining a healthy and balanced system.
- Trial name
- NCT05834036
- Testing
- Amoxicillin Oral Capsule
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Rockefeller University
Whole Cell Pertussis, Tetanus
Safety Study of Tritanrix-HepB/Hib-MenAC, Tritanrix-HepB/Hiberix, and Mencevax ACWY Vaccines in Children
This study will be conducted in two stages. In the diphtheria, tetanus, pertussis (DTP) booster phase, subjects will receive a booster dose of Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hiberix (active control) at 15 to 18 or 24…
- Conditions
- Whole Cell Pertussis, Tetanus, Hepatitis B, Diphtheria
- Trial name
- NCT00228917
- Testing
- Tritanrix-HepB/Hib-MenAC, Tritanrix-HepB/Hiberix, Mencevax-ACWY
- Where
- 2 sites in Philippines, Thailand
- Volunteers
- 798 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Acellular Pertussis, Tetanus
Persistence Study of GSK Biologicals' Tdap Vaccine 1, 3, 5 and 9 Years Following Administration as an Initial Single Dose in Healthy Young Adults and to Evaluate the Immunogenicity and Safety of Boostrix as a Second Dose of Tdap, When Administered at Year 9
The purpose of this study is to evaluate the persistence of antibodies against all the vaccine antigens 1, 3, 5 and 9 years after an initial vaccination with Tdap, and also to assess immunogenicity and safety of another dose of…
- Conditions
- Acellular Pertussis, Tetanus, Diphtheria
- Trial name
- NCT00489970
- Testing
- Taking of blood samples, Boostrix, Adacel
- Where
- 37 sites in United States
- Volunteers
- 1,954 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Leukemia, Lymphocytic, Acute, Leukemia, Myeloid, Acute
High- Fiber/ Low-fat Diet for Prevention of Recurrent Clostridioides Difficile Infection in Oncology
The primary objective of the study is to determine whether dietary intervention to increase fiber and decrease fat reduces C. difficile infection recurrence in a cohort of oncology patients.
- Conditions
- Leukemia, Lymphocytic, Acute, Leukemia, Myeloid, Acute, Lymphoma, Clostridium Difficile Infection
- Trial name
- NCT04940468
- Testing
- Diet Intervention
- Where
- 2 sites in United States
- Volunteers
- 8 people
- Sponsor
- University of Colorado, Denver
Bacterial Infections, Virus Diseases
A Study of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-006)
This study will determine whether three manufacturing lots of V419 (PR5I) induce similar immune responses to all of the antigens contained in V419 when given concomitantly with Prevnar13™ and RotaTeq™.
- Trial name
- NCT01340937
- Testing
- V419, PENTACEL™, Prevnar 13™
- Volunteers
- 2,808 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Clostridioides Difficile Infection
Evaluation of CRS3123 vs. Oral Vancomycin in Adult Patients With Clostridioides Difficile Infection
The purpose of this research is to evaluate the primary objectives of safety and efficacy (rate of clinical cure) of 2 dosages of CRS3123 (200 mg and 400 mg) administered orally (po) twice daily (bid) and vancomycin administered…
- Trial name
- NCT04781387
- Testing
- CRS3123, Active Comparator
- Where
- 20 sites in United States, Canada
- Volunteers
- 43 people
- Sponsor
- Crestone, Inc
Bacterial Infections, Virus Diseases
Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 11 to 12 Months (V419-008)
This study will determine whether participants who receive V419 (PR5I) at 2, 4, and 11 to 12 months of age have an acceptable response to the vaccine.
- Trial name
- NCT01480258
- Testing
- PR5I, Rotavirus vaccine, Prevenar 13™
- Volunteers
- 1,315 people, healthy volunteers welcome
- Sponsor
- MCM Vaccines B.V.
Acellular Pertussis, Diphtheria
Immunogenicity and Reactogenicity of a Booster Dose of GSK Bio's DTPa-HBV-IPV/Hib Vaccine
The purpose of this booster study is to evaluate, in subjects primed in the primary study 106786, the persistence, at the time of the booster vaccination, of antibodies elicited by the different formulation of DTPa-HBV-IPV/ Hib…
- Conditions
- Acellular Pertussis, Diphtheria, Poliomyelitis, Haemophilus Influenzae Type b
- Trial name
- NCT00627458
- Testing
- Infanrix Hexa
- Where
- 6 sites in Finland
- Volunteers
- 403 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Clostridium Infections
Safety, Tolerability, and Immunogenicity of a Clostridium Difficile Toxoid Vaccine in Healthy Elderly Volunteers
The purpose of this study is to determine the safety and tolerability of a modified C. difficile vaccine at 3 dose levels compared with a placebo control administered via intramuscular injection in healthy elderly subjects aged >…
- Trial name
- NCT00214461
- Testing
- C. difficile toxoid vaccine (2 µg), C. difficile toxoid vaccine (10 µg), C. difficile toxoid vaccine (50 µg)
- Where
- 2 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Sanofi
Healthcare Associated Infection, Clostridium Difficile Infection
Pulsed UV Xenon Disinfection to Prevent Resistant Healthcare Associated Infection
The objective is to conduct a prospective, sham controlled, double-blinded, interventional crossover trial to compare standard terminal cleaning plus PX-UV (intervention) with standard terminal cleaning plus sham PX-UV (control)…
- Conditions
- Healthcare Associated Infection, Clostridium Difficile Infection, Infection Due to Multidrug Resistant Bacteria
- Trial name
- NCT03349268
- Testing
- Pulsed xenon ultraviolet (PX-UV) Device
- Where
- United States
- Volunteers
- 25,732 people
- Sponsor
- University of Michigan
Diphtheria, Tetanus
Immunogenicity Study of Antibody Persistence and Booster Effect of PENTAXIM™ at 18 Months in Healthy Argentinean Infants
This study will assess both the antibody persistence of the investigational vaccine and the immune response and safety of a booster dose of PENTAXIM™ vaccine in 18 months-old toddlers who participated in an earlier study in order…
- Conditions
- Diphtheria, Tetanus, Pertussis, Poliomyelitis
- Trial name
- NCT00303316
- Testing
- DTaP-IPV//PRP~T combined vaccine
- Where
- Argentina
- Volunteers
- 458 people, healthy volunteers welcome
- Sponsor
- Sanofi
Clostridium Difficile Infection
A Study of MK-3415, MK-6072, and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection (MK-3415A-001)
This study will investigate whether: 1) treatment with MK-3415A in addition to standard of care (SOC) antibiotic therapy will decrease Clostridium difficile infection (CDI) recurrence as compared to treatment with MK-6072 or…
- Trial name
- MODIFY I (NCT01241552)
- Testing
- MK-3415, MK-6072, MK-3415A
- Volunteers
- 1,452 people
- Sponsor
- Merck Sharp & Dohme LLC
Clostridium Difficile Infection
FMT Versus Antimicrobials for Initial Treatment of Recurrent CDI
The purpose of the study is to determine the safety and efficacy of Fecal Microbiota Transplant (FMT) for the treatment of the recurrence of Clostridium difficile infection (CDI) as compared to standard antibiotic therapy.
- Trial name
- NCT02255305
- Testing
- FMT, Antimicrobials
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Endeavor Health
Diphtheria, Tetanus
Lot Consistency Study of DTaP-IPV-HB-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy Infants
The purpose of this trial is to clinically confirm that the manufacturing process of the final bulk products of the investigational DTaP-IPV-HB-PRP~T vaccine is consistent.
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT00404651
- Testing
- DTaP-IPV-HB-PRP~T vaccine, DTaP-HBV-IPV vaccine
- Where
- 6 sites in Mexico
- Volunteers
- 1,189 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Clostridium Difficile Infection
A Study of MK-6072 and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection (MK-3415A-002)
MK-3415A is the combination of monoclonal antibodies to Clostridium (C.) difficile toxin A (MK-3415) and toxin B (MK-6072). This study will investigate whether: 1) treatment with MK-6072 or MK-3415A in addition to standard of…
- Trial name
- MODIFY II (NCT01513239)
- Testing
- MK-6072, MK-3415A, SOC
- Volunteers
- 1,203 people
- Sponsor
- Merck Sharp & Dohme LLC
Tetanus, Diphtheria
Immunogenicity and Safety Study of GSK Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 3 and 4 Months of Age
This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine co-administered with GSK Biologicals' 10-valent pneumococcal conjugate (GSK1024850A) vaccine given as a three-dose primary vaccination…
- Conditions
- Tetanus, Diphtheria, Haemophilus Influenzae Type b, Poliomyelitis
- Trial name
- NCT00970307
- Testing
- GSK2202083A vaccine, 10-valent pneumococcal vaccine (GSK 1024850A), Infanrix hexa™
- Where
- 9 sites in Poland
- Volunteers
- 421 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Clostridial Infection, Dysbiosis
Safety and Efficacy of FMT in Individuals With One or More Recurrences of Clostridium Difficile Associated Disease (CDAD)
Multi-center, randomized, placebo controlled, partially blinded trial comparing the safety and efficacy of fecal microbiota transplantation versus placebo both delivered by rectal enema in subjects 18 years of age or older with…
- Conditions
- Clostridial Infection, Dysbiosis, Probiotic Therapy
- Trial name
- NCT03548051
- Testing
- Fecal Microbiota Transplantation (FMT), Saline
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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.