Campylobacter Jejuni Challenge Model Development: Dose Ranging Study

You may not qualify if:

• Presence of a significant medical condition, (e.g. psychiatric conditions or gastrointestinal disease, such as peptic ulcer, symptoms or evidence of active gastritis, inflammatory bowel disease, irritable bowel syndrome, alcohol or illicit drug abuse/dependency), or other laboratory abnormalities which in the opinion of the investigator precludes participation in the study.
• Immunosuppressive illness, IgA deficiency (below the normal limits), or antihistamine use within 48 h of admission or during inpatient period.
• Positive serology results for HIV, HBsAg, or HCV antibodies.
• Significant abnormalities in screening lab hematology, serum chemistry, as determined by PI or PI in consultation with the medical monitor and sponsor.
• Use of any medication known to affect the immune function (e.g., corticosteroids and others) within 30 days preceding receipt of the challenge inoculum or planned use during the active study period.
• Are not capable of fully informed consent (e.g. cannot read or write English)
• Personal or documented family history of an inflammatory arthritis such as reactive arthritis, Reiter's syndrome, ankylosing spondylitis, rheumatoid arthritis, or Guillain-Barré syndrome (would not include osteoarthritis or vague history of arthritis relatively late in adulthood).
• Evidence of neurologic abnormalities (specifically extremity weakness, abnormal deep tendon reflexes, symmetric sensory abnormalities - vibratory, light touch, and proprioception).
• Evidence of inflammatory arthritis on exam and/or HLA-B27 positive.
• Allergy or prior intolerance to either azithromycin or fluoroquinolones.
• Fewer than 3 stools per week or more than 3 stools per day as the usual frequency, loose or liquid stools other than on an occasional basis.
• Regular use of laxatives or any agent that increase gastric pH (regular defined as at least weekly).
• A recent fever in the 2 weeks prior to time of challenge.
• Use of antibiotics during the 7 days before bacterial dosing or proton pump inhibitors, H2 blockers, or antacids within 48 hours of dosing.
• Use of any investigational product within 30 days preceding the receipt of the challenge inoculum, or planned use during the active study period.
• +10 more criteria