Antibiotic therapy for children with active Crohn's disease

• Register: EUCTR
• Last refreshed on: 25 April 2016
• Main ID: EUCTR2012-005226-29-PL
• Date of registration: 19/09/2013
• Prospective Registration: Yes
• Primary sponsor: Erasmus MC
• Public title: Antibiotic therapy for children with active Crohn's disease
• Scientific title: Azithromycin Based Therapy for Induction of Remission in Active Pediatric Crohn's Disease - AZCRO
• Date of first enrolment: 16/01/2014
• Target sample size: 70
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-005226-29
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: yes Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Belgium, Canada, Israel, Netherlands, Poland, Portugal, United States

Contacts

• Name: J.C. Escher
• Affiliation: Erasmus MC Sophia Childrens Hospital

• Name: J.C. Escher
• Affiliation: Erasmus MC Sophia Childrens Hospital

Key inclusion & exclusion criteria

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Crohn's disease

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Intervention(s)

Product Name: azithromycin
Pharmaceutical Form: Tablet

Trade Name: metronidazole
Product Name: metronidazole
Pharmaceutical Form: Tablet

Product Name: azithromycin
Pharmaceutical Form: Tablet

Product Name: azithromycin
Pharmaceutical Form: Granules for oral solution

Primary Outcome(s)

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(s)

Timepoint(s) of evaluation of this end point: 8 weeks

Secondary end point(s): Normalization of CRP
Change in fecal calprotectin from baseline

Secondary ID(s)

IBD-0337

NCT01596894

2012-005226-29-NL

Source(s) of Monetary Support

Wolfson Medical Center

University hospital Brussel

Hospital S. Joao

Secondary Sponsor(s)

Jagiellonian University Medical College

Hospital S. Joao

University hospital Brussel