EUCTR2012-000252-34-SE进行中（未招募）1 期
A Randomized, Double-Blinded, Active-Controlled Study of CB-183,315 in Patients with Clostridium Difficile Associated Diarrhea
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 606
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •To be eligible for enrollment, a subject must meet all of the following criteria prior to any study related procedures:
- •1. Informed Consent obtained and signed;
- •2. Age =18 and <90 years;
- •3. If female, subject must not be pregnant or nursing, and must be either:
- •a. Not of childbearing potential: defined as postmenopausal for at least 1 year or surgically sterile due to bilateral tubal ligation, bilateral oophorectomy, or hysterectomy (no pregnancy test required if 1 of these conditions are met; or
- •b. If of childbearing potential (and confirmed to not be pregnant by a negative serum or urine pregnancy test):
- •i. Must either abstain from sexual intercourse or;
- •ii. Must practice a barrier method of birth control (e.g., a diaphragm or contraceptive sponge) and 1 of the following methods: oral or parenteral contraceptives (oral or parenteral contraceptives must have been used for at least 3 months prior to study drug administration), or
- •iii. Must have a vasectomized partner.
- •4. Has diarrhea with a minimum of three unformed bowel movements or >200 mL volume of stool for subjects with a collection device (eg. rectal tube or colostomy bag) over a period of 24 hours just prior randomization/first dose of study drug; and
- •5. Has a positive result for C. difficile toxin by EIA, PCR, or a cell culture cytotoxin neutralization assay from a sample obtained within 48 hours prior to first dose of study drug.
- •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 243
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 365
排除标准
- •A subject will not be enrolled if the subject meets any of the following criteria:
- •1. Toxic megacolon and/or known small bowel ileus;
- •2. Received treatment with intravenous immune globulin (IVIG) within 30 days prior to the first dose of study drug;
- •3. Received treatment with a fecal transplant within 7 days, and/or is anticipated to receive a fecal transplant during the study.
- •4. Antibacterial therapy specific for current CDAD:
- •Received >4 doses or >24 hours of oral vancomycin for the current episode of CDAD prior to first dose of study drug.
- •Received >4 doses or >24 hours of oral/IV metronidazole for the current episode of CDAD prior to first dose of study drug unless patient received at least 3 days of such therapy, and is
- •considered a treatment failure for CDAD.
- •Received >24 hours of any other antibacterial for the current CDAD within 14 days prior to the first dose of study drug, unless considered a treatment failure for CDAD.
- •5. Received an investigational vaccine against C. difficile;
- •6. Received an investigational product containing monoclonal antibodies against toxin A or B within 180 days prior to first dose of study drug;
- •7. Patients with more than 2 episodes of CDAD, including the current episode, within 90 days of start of study therapy (i.e., patients can be enrolled with their 1st recurrence/2nd episode);
- •8. Major gastrointestinal (GI) surgery (i.e. significant bowel resection) within 3 months of enrollment;
- •9. History of prior inflammatory bowel disease: ulcerative colitis, Crohn’s disease, or microscopic colitis;
- •10. Continues to take loperamide, diphenoxylate/atropine, or cholestyramine during the duration of the study;
- •11. Continues to take opiate treatment unless on a stable dose as of onset of diarrhea and no increase in dose planned for the duration of the study;
- •12. Known positive stool cultures for other enteropathogens including but not limited to Salmonella, Shigella, and Campylobacter;
- •13. Known stool studies positive for pathogenic ova and/or parasites;
- •14. Known intolerance or hypersensitivity to daptomycin and/or vancomycin;
- •15. Life-threatening illness at the time of enrollment as measured by a score of 4 using a modified Horn’s index;
- •16. Poor concurrent medical risks with clinically significant co-morbid disease such that in the opinion of the Investigator the patient should not be enrolled;
- •17. Received an investigational drug or participated in any experimental procedure within 1 month prior to start of study therapy (Investigational use of approved products may be permitted with the approval of the Medical Monitor);
- •18. Subjects with HIV, whose latest CD4 count is <200 cells/mm3 or there is evidence of clinical immunosuppression;
- •19. Anticipated that systemic antibacterial therapy for a non-CDAD infection will be required for >7 days after start of study therapy;
- •20. Continues to take Saccharomyces or similar probiotic;
- •21. Concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy
- •22. Unable/unwilling
研究者
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