A research study to determine if VP 20621 can prevent another episode of Clostridium difficile infection (CDI) in adults who were already treated for CDI
- Conditions
- Clostridium difficile infectionMedDRA version: 14.1Level: LLTClassification code 10054236Term: Clostridium difficile infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2010-020484-20-DE
- Lead Sponsor
- ViroPharma Incorporated
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 174
To be eligible for this protocol, subjects must:
1.Be =18 years of age.
2.Have been diagnosed with a qualifying episode of CDI, defined as ALL of the following:
•=3 unformed (loose or watery) stools within a 24-hour period.
•A documented positive C. difficile toxin assay (enzyme immunoassay [EIA] or cellular cytotoxicity assay) or DNA PCR assay for toxigenic C. difficile from a stool sample collected while the subject was symptomatic; or documented colonic pseudomembranes on endoscopy.
•The diarrhea must have been considered unlikely to have another etiology.
3.Have a qualifying episode of CDI with symptoms that started within 28 days (inclusive) prior to the day of randomization.
4.Have a qualifying episode of CDI that is either a primary episode or a first recurrence of a prior episode.
•Primary episode: the subject had no episodes of CDI (other than the qualifying episode) within 6 months before the day of randomization.
•First recurrence: the subject had only one episode of CDI (other than the qualifying episode) within 6 months before the day of randomization; the prior episode of CDI was diagnosed within 8 weeks before the onset of symptoms of the qualifying episode of CDI, and subsequently resolved (in the opinion of the investigator) at least 2 days before the onset of the qualifying episode of CDI.
5.At the time of randomization, have been treated for the qualifying episode of CDI with a single course of metronidazole or oral vancomycin for a total of at least 10 and no more than 21 days. [The treatment may have switched between metronidazole (oral or intravenous) and oral vancomycin, provided that the total treatment course was of 10 21 days duration (inclusive).]
6.Have recovered from the qualifying episode of CDI, defined as ALL of the following:
•<3 unformed (loose or watery) stools per day for at least 2 consecutive days prior to and continuing to the time of randomization.
•Abdominal discomfort must be absent or only mild for at least 2 consecutive days prior to and continuing to the time of randomization.
7.Be randomized such that the first dose of study drug is administered 1 calendar day (or at most 2 calendar days) after the end of the course of metronidazole or oral vancomycin.
8.Be willing and able to follow study procedures (e.g., study visits, provide stool samples according to the study schedule, and reliably record information in a study diary), or have a caregiver who can ensure that study procedures are followed.
9.If female, be post-menopausal (cessation of menses greater than or equal to 1 year), surgically sterile or following an acceptable non-hormonal method of birth control such as abstinence, intrauterine device, or barrier control for at least 1 complete menstrual cycle before the screening visit, or using estrogen/progestin containing products for at least 3 months before the screening visit through discharge from the study.
10.Have reliable access to telephone service to allow for contact with study personnel.
11.Have reliable access to a refrigerator for storage of study drug.
12.Be informed of the nature of the study and provide written informed consent before any study-specific procedures are performed (or have a legally authorized representative provide such consent).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of sub
To be eligible for this protocol, subjects must not:
1.Have had more than 1 episode of CDI (other than the qualifying episode) within 6 months before the day of randomization.
2.Have received any of the following for treatment of the qualifying episode of CDI:
•Any anti-microbial therapy other than metronidazole or oral vancomycin
•Any immunotherapy (e.g., intravenous immunoglobulin)
•Any toxin-binding therapy (e.g., cholestyramine [Questran], colestipol [Colestid], or colesevelam [Welchol])
3.Have any of the following GI disorders:
•diagnosis of inflammatory bowel disease
•diagnosis of celiac disease
•active irritable bowel syndrome (associated with symptoms within 6 months before the day of randomization)
•active gastroparesis (associated with symptoms within 6 months before the day of randomization)
•toxic megacolon during the qualifying episode of CDI
•GI surgery within 6 weeks before the day of randomization
4.Have received loperamide (e.g., Imodium), diphenoxylate (e.g., Lomotil), or opium tincture (including laudanum and paregoric) within 3 days before the day of randomization.
5.Have an acute febrile illness (fever >38?C [100.4?F]) on Day 1 prior to the first dose of study drug.
6.Be planning to receive any oral or parenteral (e.g., intravenous, intramuscular, or intraperitoneal) antibacterial therapy after randomization.
7.Have any contraindication to oral/enteral therapy (e.g., severe nausea/vomiting or ileus).
8.Have an absolute neutrophil count <1000/mm3 [1.0 x 109/L] at screening.
9.Have a known immunodeficiency disorder, including but not limited to:
•HIV infection
•receiving treatment with systemic corticosteroids at a dosage equivalent to =10 mg/day of prednisone
•receiving myelosuppressive cancer chemotherapy
10.If outpatient at any time during the study, have household contacts (i.e., those who also occupy the subject’s particular housing unit as their residence during this time) who are <2 years of age or who have an immunodeficiency disorder (including but not limited to the conditions listed in Exclusion criterion #9).
11.Require or have an anticipated need for mechanical ventilation or vasopressors for hemodynamic support during the study.
12.Be pregnant or breastfeeding.
13.Have participated in an active dosing phase of any other investigational (unapproved) drug evaluation within 30 days prior to the screening visit.
14.Have any clinically significant medical or surgical condition that in the investigator’s or sponsor’s opinion could interfere with the administration of study drug, interpretation of study results, or compromise the safety or well-being of the subject.
15.Have a known hypersensitivity to any ingredient in the study formulation.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method