Phase 2
N=168
Safety and Efficacy Study of VP20621 for Prevention of Recurrent Clostridium Difficile Infection
Clostridium Difficile Infection
Bottom Line
View on ClinicalTrials.gov: NCT01259726 ↗Enrolled (actual)
168
Serious AEs
16.1%
Results posted
Feb 2015
Primary outcome: Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) — 37; 33; 34; 31 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- VP20621 (Biological); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shire
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
37; 33; 34; 31; 3; 1 | — |
| PRIMARY Number of Participants With Positive Clostridium Difficile Stool Cultures Demonstrating Non-Toxigenic Clostridium Difficile-Strain M3 |
4; 26; 31; 29 | <=0.0001 sig |
| SECONDARY Number of Participants With Clostridium Difficile Infection (CDI) Recurrence |
13; 6; 2; 6 | =0.088 |
| SECONDARY Number of Participants With Use of Antibacterial Treatment for CDI |
14; 6; 4; 7 | =0.054 |
| SECONDARY Number of Participants With Clinical Events of Diarrhea or Loose/Watery Stools |
33; 23; 25; 23 | =0.045 sig |
| SECONDARY Time to First CDI Recurrence |
NA; NA; NA; NA | — |
Summary
The objectives of this study are: (1) to evaluate the safety and tolerability of VP 20621 dosed orally for up to 14 days in adults previously treated for CDI; (2) to characterize the frequency and duration of stool colonization with the VP 20621 strain of C. difficile; (3) to evaluate the efficacy of VP 20621 for prevention of recurrence of CDI; and (4)to select a dose regimen of VP 20621 to be used in future studies.
Eligibility Criteria
Inclusion Criteria
- Adult subjects, 18 years of age and over, who understand the risks and benefits of participation and have provided written informed consent for the study.
- Subjects who are experiencing a first event or first recurrence of clostridium difficile (CDI) within the last 28 days and have been successfully treated with an antibiotic for CDI.
- Subjects who are medically stable.
- Subjects who are willing and able to comply with the study procedures and visit schedules outlined.
- If female be post-menopausal, surgically sterile or agree to follow an acceptable method of birth control.
Exclusion Criteria
- Subjects who have had more than 2 episodes of CDI within the last 6 months.
- Subjects who have been diagnosed with Inflammatory Bowel Disease,active Irritable Bowel Syndrome, celiac disease, active gastroparesis, toxic megacolon.
- GI surgery within 6 weeks before the day of randomization
- Have known immunodeficiency disorder, such as HIV Infection
- Pregnant or breast feeding females.
- Concurrent acute life-threatening diseases.
- Inability to tolerate oral liquids.
- Have an absolute neutrophil count < 1000/mm3 at screening
Data sourced from ClinicalTrials.gov (NCT01259726). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.