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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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25 April 2016 |
Main ID: |
EUCTR2012-005226-29-PL |
Date of registration:
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19/09/2013 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Antibiotic therapy for children with active Crohn's disease
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Scientific title:
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Azithromycin Based Therapy for Induction of Remission in Active Pediatric Crohn's Disease - AZCRO |
Date of first enrolment:
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16/01/2014 |
Target sample size:
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70 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-005226-29 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
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Phase:
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Countries of recruitment
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Belgium
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Canada
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Israel
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Netherlands
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Poland
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Portugal
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United States
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Contacts
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Name:
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J.C. Escher
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Address:
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Dr. Molewaterplein 60
3015 GJ
Rotterdam
Netherlands |
Telephone:
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+31107036076 |
Email:
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j.escher@erasmusmc.nl |
Affiliation:
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Erasmus MC Sophia Childrens Hospital |
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Name:
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J.C. Escher
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Address:
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Dr. Molewaterplein 60
3015 GJ
Rotterdam
Netherlands |
Telephone:
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+31107036076 |
Email:
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j.escher@erasmusmc.nl |
Affiliation:
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Erasmus MC Sophia Childrens Hospital |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Crohn's disease
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Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
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Intervention(s)
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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
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Primary Outcome(s)
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Primary end point(s): response rate at 8 weeks.
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Timepoint(s) of evaluation of this end point: 8 weeks
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Main Objective: Efficacy of remission induction by azithromycin + metronidazole versus metronidazol alone in pediatric Crohn's disease
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Secondary Objective: Change inflammatory parameters
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: 8 weeks
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Secondary end point(s): Normalization of CRP Change in fecal calprotectin from baseline
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Secondary ID(s)
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2012-005226-29-NL
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IBD-0337
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NCT01596894
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Source(s) of Monetary Support
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Wolfson Medical Center
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University hospital Brussel
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Hospital S. Joao
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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