Personalized AZithromycin/metronidAZole Therapy in Pediatric Crohn's Disease (CD)

Exclusion Criteria

• •1. Current or previous use of biologic therapy;
• •2. Presence of stricturing, penetrating (intestinal or perianal) and/or fistulizing CD;
• •3. Pregnancy or lactation;
• •4. Have undergone intestinal resection;
• •5. Positive Clostridium Difficile toxin;
• •6. Treatment with another investigational drug or other intervention within 30 days before week 0;
• •7. Risk factors for arrhythmia including history of prolonged corrected QT interval (QTc), hypokalemia or hypomagnesemia, resting bradycardia, or concurrent treatment with other drugs with potential for QT prolongation;
• •8. History of cockayne syndrome;
• •9. Prior diagnosis of any hematologic condition/blood dyscrasia which may result in leukopenia (even if leukocyte count is normal at screening);
• •10. Known allergy or intolerance to azithromycin or metronidazole;
• •11. Subjects who received intravenous anti-infective within 35 days prior to week 0 visit or anti-infectives within 14 days prior to the week 0 visit;
• •12. Subject on oral aminosalicylates who has not been on stable doses for greater than, or discontinued within, at least 14 days prior to week 0;
• •13. Subject on cyclosporine, tacrolimus or mycophenolate mofetil. Stable doses (no change within 14 days prior to week 0) of azathioprine, 6-mercaptopurine or methotrexate (MTX) are not a reason for exclusion;
• •14. Subject who received fecal microbial transplantation within 35 days prior to week 0 visit;
• •15. Screening laboratory and other analyses show any of the following abnormal results:
• •* aspartate transaminase (AST), alanine transaminase (ALT) \> 2 X upper limit of the reference range,
• •* White blood cell (WBC) count \< 3.0 X 109/L,
• •* Total bilirubin \>= 20 micromol/liter (1.17 mg/dL); except for subjects with isolated elevation of indirect bilirubin relating to Gilbert syndrome,
• •* Estimated glomerular filtration rate (GFR) by simplified 4-variable Modification of Diet in Renal Disease (MDRD) formula of \< 30 mL/min/1.73 m²,
• •* Hemoglobin \< 80 gram/liter,
• •* Platelets \< 100,000/µL.