Antibiotic therapy for children with active Crohn's disease

• Conditions: Crohn's disease; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2012-005226-29-PL
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-19
• Last Update Posted: 25 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 70

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
Are the trial subjects under 18? yes
Number of subjects for this age range: 70
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 to any other macrolide antibiotics
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Efficacy of remission induction by azithromycin + metronidazole versus metronidazol alone in pediatric Crohn's disease;Secondary Objective: Change inflammatory parameters;Primary end point(s): response rate at 8 weeks.;Timepoint(s) of evaluation of this end point: 8 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Normalization of CRP<br>Change in fecal calprotectin from baseline;Timepoint(s) of evaluation of this end point: 8 weeks