In This SectionTexas Health Research & Education Institute
Disease or Condition
A study of CB-183,315 in Patients with Clostridium Difficile Assocaited Diarrhea (Gastroenterology)
This is a medical research study designed to look at the safety and efficacy of an oral dose of CB 183,315 (the study drug) and oral vancomycin (an approved antibiotic) against CDAD (Clostridium difficile Associated Diarrhea).
Informed Consent obtained and signed.
Age =18 and <90 years.
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 (eg, 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.
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 the chosen contraception method for the duration of treatment and for at least 40 days after the last dose of study medication.
Has diarrhea with a minimum of 3 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 to randomization/first dose of study drug; and 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.
Toxic megacolon and/or known small bowel ileus.
Received treatment with intravenous immune globulin (IVIG) within 30 days prior to the first dose of study drug.
Received treatment with a fecal transplant within 7 days, and/or is anticipated to receive a fecal transplant during the study.
Antibacterial therapy specific for current CDAD:
a. Received >4 doses or >24 hours of oral vancomycin for the current episode of CDAD prior to first dose of study drug.
b. 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.
c. 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.
Received an investigational vaccine against C. difficile.
Received an investigational product containing monoclonal antibodies against toxin A or B within180 days prior to first dose of study drug.
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).
Major GI surgery (i.e. significant bowel resection) within 3 months of enrollment (this does not include appendectomy or cholecystectomy).
History of prior inflammatory bowel disease: ulcerative colitis, Crohn’s disease, or microscopic colitis.
Continues to take loperamide, diphenoxylate/atropine, or cholestyramine during the duration of the study.
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.
Known positive stool cultures for other enteropathogens including but not limited to Salmonella, Shigella, and Campylobacter.
Known stool studies positive for pathogenic ova and/or parasites.
Known intolerance or hypersensitivity to daptomycin and/or vancomycin.
Life-threatening illness at the time of enrollment as measured by a score of 4 using a modified Horn’s index.
Poor concurrent medical risks with clinically significant co-morbid disease such that in the opinion of the Investigator the patient should not be enrolled.
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).
Subjects with HIV, whose latest CD4 count is <200 cells/mm3 or who show evidence of clinical immunosuppresion.
Anticipated that systemic antibacterial therapy for a non-CDAD infection will be required for >7 days after start of study therapy.
Continues to take Saccharomyces or similar probiotic.
Concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy (subjects on consolidation cycles of chemotherapy may only be enrolled after consultation with Medical Monitor).
Unable/ unwilling to comply with the protocol requirements.
Any condition that, in the opinion of the Investigator, might interfere with study objectives.