Azithromycin Based Therapy for Induction of Remission in Active Pediatric Crohn's Disease

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 6

Inclusion Criteria

1. Children 5-17 years of age;2. Diagnosis of active Crohn's disease;3. Patients with a PCDAI equal of more then 10 and equal or less then 40 (mild to moderate disease);4. Have involvement of the colon and/or terminal ileum;5. Disease defined as L1, L2, L3 or any of the above and may have gastric, duodenal or esophageal disease (L4a) according to the paris classification for site of disease;6. The CRP is equal or more then 0.6 mg/dL;7. Duration of disease since diagnosis equal or less then 3 years;8. Negative stool culture, Clostridium Difficile Toxin from current flare

Exclusion Criteria

1. Duration of disease since diagnosis more then 3 years.
2. Positive stool culture or O&P last 30 days.
3. Presence of clostridium difficile toxin in stool.
4. Azithromycin or Metronidazole allergy or known intolerance.
5. Diagnosis of IBD-U
6. Presence of macroscopic disease involving the proximal ileum or jejunum (L4b)
7. Continuous macroscopic disease of the colon appearing as typical ulcerative colitis and Crohns diagnosed only by focality or granuloma on biopsies.
8. Presence of extraintestinal manifestations (such as arthritis, uveitis, or sclerosing cholangitis). Apthous lesions of mouth can be included.
9. Presence of fibrostenotic disease (strictures with prestenotic dilatation).
10. Presence of penetrating disease (fistulas or abscess).
11. Presence of current perianal disease defined as fistula or abscess.
12. Patients receiving concurrent corticosteroids or biologics.
13. Patients who have received steroids in the past 14 days.
14. Immune deficiency (CGD, GSD1, IL10R etc).
15. Known allergy or intolerance to any of the study medications.
16. Concurrent disease such as hepatitis, ALT more then 2 times, UNL, renal failure.
17. Pregnancy,
18. Patients with known heart disease.
19. Prolonged QTc by ECG at baseline.
20. Patients after surgical intestinal resection.
21. Present use of medications known to prolong QTc, such as cisapride, terfenadine, domperidone, erythromycin, and ergotamines.
22. Present use of acenocoumarol or digoxin.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Response rate at 8 weeks defined as a drop in PCDAI of at least 12.5 points (or<br /><br>remission without steroids, intention to treat principle)</p><br>

Secondary Outcome Measures