Clostridium Infections Clinical Trial
Official title:
A Phase I Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study of the Safety, Tolerability and Immunogenicity of a Clostridium Difficile Toxoid Vaccine, Alum Adsorbed, in Healthy Elderly Volunteers (> or =65 Years)
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 > or = 65 years. This is the companion study to H-030-008, in which healthy younger adults have already been dosed.
Clostridium difficile is the leading infectious cause of nosocomial diarrhea in developed countries. Hospital outbreaks of Clostridium difficile-associated diarrhea (CDAD) are associated with substantial patient morbidity and mortality. Conventional therapy with antibiotics often results in secondary infection with resistant organisms or clinical relapse after discontinuation of the antimicrobial course. New strategies are needed to limit the impact of this opportunistic pathogen. Considerable evidence exists that immunity against C. difficile toxins may be effective in controlling CDAD. 48 subjects will be enrolled to receive one of three dose levels of modified C difficile vaccine or placebo administered on a 3-dose schedule. The study consists of a 30-day screening period, a 70-day treatment period, one follow-up phone interview 2 months after the last vaccination, and one follow-up clinic visit 6 months after the last vaccination. ;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04179201 -
Study on Clostridium Difficile Infection in Chinese Patients With Inflammatory Bowel Disease
|
||
| Completed |
NCT02563106 -
A Study of SYN-004 for the Prevention of C.Diff in Patients With a LRTI
|
Phase 2 | |
| Completed |
NCT00314951 -
Fidaxomicin Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)
|
Phase 3 | |
| Completed |
NCT00328263 -
Efficacy and Safety of BIO-K + CL1285 in Prevention of Antibiotic-associated Diarrhea in Hospitalized Adult Patients
|
Phase 3 | |
| Completed |
NCT00127803 -
Safety, Tolerability, and Immunogenicity Study of a Clostridium Difficile Toxoid Vaccine in Healthy Adult Volunteers
|
Phase 1 | |
| Completed |
NCT00350298 -
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
|
Phase 2 | |
| Withdrawn |
NCT05077085 -
Bezlotoxumab Versus FMT for Multiple Recurrent CDI
|
Phase 4 | |
| Recruiting |
NCT02681068 -
MicroTrans - A Multicenter Registry of Fecal Microbiota Transplantation
|
N/A | |
| Completed |
NCT00446355 -
Clinical Outcomes of Patients With Clostridium Difficile Associated Disease Attributable to Diverse tcdC Genotypes
|
N/A | |
| Terminated |
NCT00384527 -
Study of Nitazoxanide in the Treatment of Clostridium Difficile-associated Disease
|
Phase 3 | |
| Completed |
NCT00269399 -
A Trial to Compare Xifaxan to Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)
|
Phase 3 | |
| Completed |
NCT04026009 -
Safety and Immunogenicity Study of GSK's Clostridium Difficile Vaccine 2904545A When Administered in Healthy Adults Aged 18-45 Years and 50-70 Years
|
Phase 1 | |
| Recruiting |
NCT06277999 -
C.Difficile Observational Study
|
||
| Completed |
NCT00468728 -
PAR-101/OPT-80 Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)
|
Phase 3 |