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Completed

NCT Number: NCT01259726

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

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.

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Key information

Conditions

Clostridium Difficile Infection Bacterial Infections Bacterial Infections and Mycoses Clostridium Infections Diarrhea Gram-Positive Bacterial Infections Infections Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Aalst, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VP20621

Biological

VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for seven days

Placebo

Other

10 mL placebo once daily for 14 days

Primary outcomes

  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Time frame: 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.

  2. Number of Participants With Positive Clostridium Difficile Stool Cultures Demonstrating Non-Toxigenic Clostridium Difficile-Strain M3

    Time frame: After study drug administration period (14 days) through Week 6

Secondary outcomes

  1. Number of Participants With Clostridium Difficile Infection (CDI) Recurrence

    Time frame: 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.

  2. Number of Participants With Use of Antibacterial Treatment for CDI

    Time frame: 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".

  3. Number of Participants With Clinical Events of Diarrhea or Loose/Watery Stools

    Time frame: 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.

  4. Time to First CDI Recurrence

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Safety and Efficacy of VP 20621 for Prevention of Recurrence of Clostridium Difficile Infection (CDI) in Adults Previously Treated for CDI

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 14, 2010
Registry last updated
Jun 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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