NL-OMON39861已完成3 期
Azithromycin Based Therapy for Induction of Remission in Active Pediatric Crohn's Disease - AZCRO
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 17（—）
入选标准
- •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
排除标准
- •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.
研究者
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