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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: 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  
Phase: 
Countries of recruitment
Belgium Canada Israel Netherlands Poland Portugal United States
Contacts
Name: J.C. Escher   
Address:  Dr. Molewaterplein 60 3015 GJ Rotterdam Netherlands
Telephone: +31107036076
Email: j.escher@erasmusmc.nl
Affiliation:  Erasmus MC Sophia Childrens Hospital
Name: J.C. Escher   
Address:  Dr. Molewaterplein 60 3015 GJ Rotterdam Netherlands
Telephone: +31107036076
Email: j.escher@erasmusmc.nl
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)
Primary end point(s): response rate at 8 weeks.
Timepoint(s) of evaluation of this end point: 8 weeks
Main Objective: Efficacy of remission induction by azithromycin + metronidazole versus metronidazol alone in pediatric Crohn's disease
Secondary Objective: Change inflammatory parameters
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)
2012-005226-29-NL
IBD-0337
NCT01596894
Source(s) of Monetary Support
Wolfson Medical Center
University hospital Brussel
Hospital S. Joao
Secondary Sponsor(s)
Jagiellonian University Medical College
University hospital Brussel
Hospital S. Joao
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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