Azithromycin Based Therapy for Induction of Remission in Active Pediatric Crohn's Disease

NCT01596894 | Completed Phase 4

• 1 other identifier: 0035-12-WOMC
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate effectiveness of 2 months antibiotic course of Azithromycin combined with Metronidazole compared with 2 months antibiotic course of Metronidazole alone.

Conditions

Crohn's Disease

Keywords

Pediatric; Crohn's disease; Azithromycin; Metronidazole; Mild to moderate Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• Response rate at 8 weeks defined as a drop in PCDAI (Pediatric Crohn's Disease Activity Index ) of at least 12.5 points (or remission without steroids, intention to treat principle)

  8 weeks

Secondary Outcomes (3)

• Normalization of CRP ( CRP ≤0.5 mg/dL).

  At week 8

• Fecal calprotectin at 8 weeks .

  8 weeks

• Remission at week 8

  8 weeks

Study Arms (2)

Azithromycin + Metronidazole

EXPERIMENTAL

Oral Azithromycin 7.5 mg/kg once daily (maximum 500mg) 5 consecutive days a week for the first 4 weeks and 3 consecutive days a week for the last 4 weeks +metronidazole 10mg/kg X2/day (maximum 1000mg) for 8 weeks.

Drug: Azithromycin + Metronidazole

Metronidazole

ACTIVE COMPARATOR

Oral metronidazole 10mg/kg X2/day (maximum 1000mg) for 8 weeks.

Drug: Metronidazole

Interventions

Azithromycin + Metronidazole DRUG

Azithromycin 7.5 mg/kg once daily (maximum 500mg) 5 consecutive days a week for the first 4 weeks and 3 consecutive days a week for the next 4 weeks +metronidazole 10mg/kg X2/day (maximum 1000mg) for 8 weeks.

Also known as: Azanil, Flagyl

Azithromycin + Metronidazole

Metronidazole DRUG

Oral metronidazole 10mg/kg X2/day (maximum 1000mg) for 8 weeks.

Also known as: Flagyl

Metronidazole

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children 5-17 years of age.
• Diagnosis of active Crohn's Disease.4. Patients with a PCDAI≥10 ≤40 (mild to moderate disease).
• Have involvement of the colon and/or terminal ileum.
• 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.
• The CRP ≥ 0.6 mg/dL.
• Duration of disease since diagnosis \< 3 years.
• Negative stool culture, Clostridium Difficile Toxin from current flare.

You may not qualify if:

• Duration of disease since diagnosis \> 3 years.
• Positive stool culture or O\&P last 30 days.
• Presence of clostridium difficile toxin in stool.
• Azithromycin or Metronidazole allergy or known intolerance.
• Diagnosis of IBD -U.
• Presence of macroscopic disease involving the proximal ileum or jejunum (L4b).
• Continuous macroscopic disease of the colon appearing as typical ulcerative colitis and Crohns diagnosed only by focality or granuloma on biopsies.
• Presence of extraintestinal manifestations (such as arthritis, uveitis, or sclerosing cholangitis).Apthous lesions of mouth can be included.
• Presence of fibrostenotic disease (strictures with prestenotic dilatation).
• Presence of penetrating disease (fistulas or abscess).
• Presence of current perianal disease defined as fistula or abscess.
• Patients receiving concurrent corticosteroids or biologics.
• Patients who have received steroids in the past 14 days.
• Immune deficiency (CGD, GSD1, IL10R etc).
• Known allergy or intolerance to any of the study medications.

Sponsors & Collaborators

• Prof. Arie Levine: lead

Study Sites (1)

The E. Wolfson.Medical Center

Holon, 58100, Israel

Location

Related Publications (1)

• Levine A, Kori M, Kierkus J, Sigall Boneh R, Sladek M, Escher JC, Wine E, Yerushalmi B, Amil Dias J, Shaoul R, Veereman Wauters G, Boaz M, Abitbol G, Bousvaros A, Turner D. Azithromycin and metronidazole versus metronidazole-based therapy for the induction of remission in mild to moderate paediatric Crohn's disease : a randomised controlled trial. Gut. 2019 Feb;68(2):239-247. doi: 10.1136/gutjnl-2017-315199. Epub 2018 Feb 2.

  PMID: 29420227 DERIVED

MeSH Terms

Conditions

Crohn Disease

Interventions

Azithromycin; Metronidazole

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Arie Levine, MD

  Pediatric Gastroenterology and Nutrition Unit, The E. Wolfson MC, Tel-Aviv University, Holon, Israel

  STUDY CHAIR

• Dan Turner, MD, PhD

  Pediatric Gastroenterology and Nutrition Unit, The Hebrew University of Jerusalem, Shaare Zedek MC, Jerusalem, Israel

  STUDY DIRECTOR

• Athos Bousvaros, MD

  Bostons Childrens Hospital

  STUDY DIRECTOR

• Michal Kori, MD

  Kaplan Medical Center

  PRINCIPAL INVESTIGATOR

• Ron Shaoul, MD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

• Eyath Wine, MD

  Women and Children's Health Research Institute, University of Alberta, Edmonton

  PRINCIPAL INVESTIGATOR

• Jorge Amil Dias, MD

  Hospital S. Joao, Porto, Porpugal

  PRINCIPAL INVESTIGATOR

• Gigi Wauters Veereman, MD

  Pedigastro, Antwerpen, Belgium

  PRINCIPAL INVESTIGATOR

• Malgorzata Margaret Sladek, MD, PhD

  Polish-American Children's Hospital

  PRINCIPAL INVESTIGATOR

• Richard Russell, MD

  Yorkhill Hospital, Glasgow, Scotland

  PRINCIPAL INVESTIGATOR

• Johanna C. (Hankje), Escher, MD PhD

  Erasmus MC-Sophia Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Pediatric Gastroenterology and Nutrition unit.

Study Record Dates

• First Submitted: April 12, 2012
• First Posted: May 11, 2012
• Study Start: October 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 10, 2017

Record last verified: 2017-08

Locations

IL (1)