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

Conditions Phase Intervention Type
  • Clostridium Difficile Infection
  • Clostridium Infections
2
Other
Placebo
Biological
VP20621

Eligibility

Ages Eligible for Study
18 years and up
Genders Eligible for Study
Both

Keywords

Diarrhea, Clostridium difficile, Clostridium infections, Signs and Symptoms Digestive, Bacterial Infections, and Pharmacologic Actions

Sponsors

Industry
Shire

Inclusion Criteria

1. 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.

2. 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.

3. Subjects who are medically stable.

4. Subjects who are willing and able to comply with the study procedures and visit
schedules outlined.

5. If female be post-menopausal, surgically sterile or agree to follow an acceptable
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

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

Detailed Description

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01259726

Locations

  • Wilhelmshaven, Germany
    ()
  • Liege, Belgium
    ()
  • Salt LakeCity, Utah United States
    ()
  • North Massapequa, New York United States
    ()
  • Sault Sainte Marie, Michigan United States
    ()
  • Royal Oaks, Michigan United States
    ()

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