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

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

Interventions

DRUG

Azithromycin + Metronidazole

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.

DRUG

Metronidazole

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

Sponsors & Collaborators

• Prof. Arie Levine

  lead OTHER_GOV

Principal Investigators

• Arie Levine, MD · Pediatric Gastroenterology and Nutrition Unit, The E. Wolfson MC, Tel-Aviv University, Holon, Israel

• Dan Turner, MD, PhD · Pediatric Gastroenterology and Nutrition Unit, The Hebrew University of Jerusalem, Shaare Zedek MC, Jerusalem, Israel

• Athos Bousvaros, MD · Bostons Childrens Hospital

• Michal Kori, MD · Kaplan Medical Center

• Ron Shaoul, MD · Rambam Health Care Campus

• Eyath Wine, MD · Women and Children's Health Research Institute, University of Alberta, Edmonton

• Jorge Amil Dias, MD · Hospital S. Joao, Porto, Porpugal

• Gigi Wauters Veereman, MD · Pedigastro, Antwerpen, Belgium

• Malgorzata Margaret Sladek, MD, PhD · Polish-American Children's Hospital

• Richard Russell, MD · Yorkhill Hospital, Glasgow, Scotland

• Johanna C. (Hankje), Escher, MD PhD · Erasmus MC-Sophia Children's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

5 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-10-31

Primary Completion

2015-12-31

Completion

2015-12-31

Countries

• Israel

Study Locations