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

Crohn's Disease research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Crohn's Disease

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Azithromycin + MetronidazoleAzithromycin 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:MetronidazoleOral metronidazole 10mg/kg X2/day (maximum 1000mg) for 8 weeks.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Azithromycin + MetronidazoleOral 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.

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

Study Status

Completed

Start Date: October 2012

Completed Date: December 2015

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: 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)

Secondary Outcome: Normalization of CRP ( CRP ≤0.5 mg/dL).

Study sponsors, principal investigator, and references

Principal Investigator: Arie Levine, MD

Lead Sponsor: Prof. Arie Levine

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01596894

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