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

Phase 2

Completed

• Conditions: Clostridium Difficile Infection
• Interventions: Biological: VP20621; Other: Placebo

• Registration Number: NCT01259726
• Lead Sponsor: Shire

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-12-09
• Study First Submitted QC: 2010-12-10
• Study First Posted: 2010-12-14
• Study Start: 2011-06-27
• Primary Completion: 2013-06-11
• Study Completion: 2013-06-11
• Results First Submitted: 2015-01-20
• Results First Submitted QC: 2015-02-11
• Results First Posted: 2015-02-12
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-30
• Last Update Posted: 2021-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 173

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VP20621 High Dose and Placebo	VP20621	-
VP20621 Low Dose and Placebo	VP20621	-
Placebo	Placebo	-
VP20621 High Dose and Placebo	Placebo	-
VP20621 Low Dose and Placebo	Placebo	-
VP20621 High Dose	VP20621	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Positive Clostridium Difficile Stool Cultures Demonstrating Non-Toxigenic Clostridium Difficile-Strain M3	After study drug administration period (14 days) through Week 6
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Baseline up to 7 days after the last dose of study drug (up to Week 3)	An adverse event (AE) is any untoward, undesired, unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiological observations occurring in a study participant, regardless of causal relationship. TEAEs were defined as all AEs that start during the study drug treatment period (and up to 7 days after the last dose of the study drug) and were not seen at baseline, or were seen at baseline but increased in frequency and/or severity during the study drug treatment period (and up to 7 days after the last dose of study drug). SAE was any AE that results in any of the following outcomes: death, a life-threatening event, inpatient hospitalization or prolongation of an existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly/birth defect, other medically important events based upon appropriate medical judgement.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Clostridium Difficile Infection (CDI) Recurrence	Baseline (Day 1) up to Week 6	CDI recurrence was defined as at least 1 event characterized by ALL of the following: \>=3 unformed (loose or watery) stools within 24 hours (data derived from Diarrhea case report form (CRF) page which was to be completed for any clinical event of diarrhea or loose/watery stool occurring between Day 1 and Week 6); a positive C. difficile stool assay, or pseudomembranes on endoscopy/surgery; and no other likely cause of the diarrhea in the opinion of the investigator.
Number of Participants With Use of Antibacterial Treatment for CDI	Baseline (Day 1) up to Week 6	Any antibacterial medication used after Day 1 for which the investigator selected the indication "antibacterial for C. difficile infection".
Number of Participants With Clinical Events of Diarrhea or Loose/Watery Stools	Baseline (Day 1) up to Week 6	Data were derived from all AEs starting on or after Day 1 for which a Diarrhea CRF page was completed.
Time to First CDI Recurrence	Baseline (Day 1) up to Week 6	CDI recurrence was defined as at least 1 event characterized by ALL of the following: \>=3 unformed (loose or watery) stools within 24 hours (data derived from Diarrhea CRF page which was to be completed for any clinical event of diarrhea or loose/watery stool occurring between Day 1 and Week 6); a positive C. difficile stool assay, or pseudomembranes on endoscopy/surgery; and no other likely cause of the diarrhea in the opinion of the investigator. Time of onset is from date of randomization to date of first CDI recurrence. Time to first CDI recurrence was assessed using Kaplan-Meier curve. Due to small number of subjects (\<50%) with CDI recurrence, median time to event was not evaluable.