Safety and Efficacy Study of VP20621 for Prevention of Recurrent Clostridium Difficile Infection

Sponsored by ViroPharma

Purpose

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.

 

Arms	Assigned Interventions
Placebo: Placebo Comparator Intervention: Other: Placebo	Other: Placebo 10 mL placebo once daily for 14 days
VP20621 Low Dose and Placebo: Experimental Interventions: Biological: VP20621 Other: Placebo	Biological: VP20621 VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for seven days Other: Placebo 10 mL placebo once daily for 14 days
VP20621 High Dose and Placebo: Experimental Interventions: Biological: VP20621 Other: Placebo	Biological: VP20621 VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for 7 days Other: Placebo 10 mL placebo once daily for 14 days
VP20621 High Dose: Experimental Intervention: Biological: VP20621	Biological: VP20621 VP20621 as oral liquid once daily for 14 days

Eligibility

Ages Eligible for Study:	18 Years and older
Genders eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 21 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 non-hormonal method of birth control.

Exclusion Criteria:

1. Subjects who have had more than 2 episodes of CDI within the last 6 months.
2. Subjects who have been diagnosed with Inflammatory Bowel Disease,active Irritable Bowel Syndrome, celiac disease, active gastroparesis, toxic megacolon.
3. GI surgery within 6 weeks before the day of randomization
4. Have known immunodeficiency disorder, such as HIV Infection or receiving current chemotherapy
5. Pregnant or breast feeding females.
6. Concurrent acute life-threatening diseases.
7. Inability to tolerate oral liquids.
8. Have an absolute neutrophil count < 1000/mm3 at screening

Physicians Involved:
Luis E Jauregui, MD
Arlette Aouad, MD
Tanyanyiwa Chinyadza, MD
Nelson Nicolasora, MD

Research Coordinators:
Dee Tilley, RN, CCRC
Pamela Beavers, RN, CCRC
Tina Steinhauser, BSN, CCRC

Please contact our office at 419-251-4919 if you believe you are eligible for this study.