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ViroPharma C Diff Banner

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.

 
ArmsAssigned 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

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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.
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