A RANDOMIZED, DOUBLE-BLINDED, ACTIVE-CONTROLLED STUDY OF CB-183,315 IN PATIENTS WITH CLOSTRIDIUM DIFFICILE ASSOCIATED DIARRHEA.

Cubist Pharmaceuticals, Inc,0 个研究点目标入组 3 人开始时间: 2013年1月16日最近更新: 2023年9月4日

试验速览

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•1. INFORMED CONSENT OBTAINED AND SIGNED;
•2. AGE ≥ 18 AND < 90 YEARS;
•3. IF FEMALE, SUBJECT MUST NOT BE PREGNANT (CONFIRMED VIA SERUM OR URINE PREGNANCY TEST), NURSING, AND IS EITHER:
•A. NOT OF CHILDBEARING POTENTIAL: DEFINED AS POSTMENOPAUSAL FOR AT LEAST ONE YEAR OR SURGICALLY STERILE DUE TO BILATERAL TUBAL LIGATION, BILATERAL OOPHORECTOMY, OR HYSTERECTOMY;
•B. IF OF CHILDBEARING POTENTIAL:
•I. EITHER ABSTAINING FROM SEXUAL INTERCOURSE OR;
•II. PRACTICING A BARRIER METHOD OF BIRTH CONTROL (E.G., A DIAPHRAGM OR CONTRACEPTIVE SPONGE) AND ONE OF THE FOLLOWING METHODS: ORAL OR PARENTERAL CONTRACEPTIVES (FOR 3 MONTHS PRIOR TO STUDY DRUG ADMINISTRATION), OR
•III HAVE A VASECTOMIZED PARTNER.
•THE ABOVE IS THE MINIMUM REQUIREMENT FOR THE STUDY. ADDITIONAL LOCAL REQUIREMENTS/RESTRICTIONS ARE ACCEPTED IN THIS PROTOCOL, CONTINGENT UPON INCLUSION IN THE CONSENT FORM.
•SUBJECTS MUST BE WILLING TO PRACTICE THESE METHODS FOR THE DURATION OF THE TRIAL AND FOR AT LEAST 40 DAYS AFTER LAST DOSE OF STUDY MEDICATION.
•4. HAS DIARRHEA WITH A MINIMUM OF THREE UNFORMED BOWEL MOVEMENTS OR >200 ML VOLUME OF STOOL FOR SUBJECTS WITH A COLLECTION DEVICE (E.G. RECTAL TUBE OR COLOSTOMY BAG) OVER A PERIOD OF 24 HOURS;

•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;
•NOTE: SUBJECTS WHO PARTICIPATED IN A MONOCLONAL ANTIBODY STUDY AND RECEIVED PLACEBO ONLY MAY BE ENROLLED INTO THIS STUDY.

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