None listed
Conditions
Interventions
A 250 MG BID DOSE REGIMEN OF CB-183,315 WILL BE COMPARED WITH THE ACTIVE COMPARATOR ORAL VANCOMYCIN (125 MG QID). SUBJECTS WITH DIARRHEA AT RISK FOR CDAD [E.G. RECEIVED PRIOR OR CONCOMITANT ANTIBIOTIC
75 YEARS) AND NUMBER OF PREVIOUS CDAD EPISODES (0 OR ≥
1) IN THE LAST 90 DAYS.
ALL SUBJECTS WILL BE EVALUATED FOR CLINICAL RESPONSE TWO DAYS AFTER LAST DOSE OF STUDY DRUG, AND WILL CONTINUED TO BE ASSESSED THROUGHOUT THE COURSE OF THE STUDY. A FAVORABL
2 LOOSE STOOLS PER 24 HOUR PERIOD FOR AT LEAST 2 CONSECUTIVE DAYS
Sponsors
Cubist Pharmaceuticals, Inc,
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. INFORMED CONSENT OBTAINED AND SIGNED; 2. AGE ≥ 18 AND 200 ML VOLUME OF STOOL FOR SUBJECTS WITH A COLLECTION DEVICE (E.G. RECTAL TUBE OR COLOSTOMY BAG) OVER A PERIOD OF 24 HOURS;
Exclusion criteria
Exclusion 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; NOTE: SUBJECTS WHO PARTICIPATED IN A MONOCLONAL ANTIBODY STUDY AND RECEIVED PLACEBO ONLY MAY BE ENROLLED INTO THIS STUDY.
Countries
Argentina, Australia, Belgium, Canada, Chile, Korea North, New Zealand, Taiwan, United States
Outcome results
None listed