Actively Recruiting
Pre-treatment With Azithromycin to Reduce Immunogenicity to to Anti-TNF Agents in Patients With Crohn's Disease
Led by Rambam Health Care Campus · Updated on 2025-04-04
180
Participants Needed
9
Research Sites
192 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a randomized placebo-controlled trial in Crohn's disease patients before initiation of anti-tumor necrosis factor-α (anti-TNF) therapy that aims to test the effect of a pre-treatment short course of azithromycin therapy on immunogenicity
CONDITIONS
Official Title
Pre-treatment With Azithromycin to Reduce Immunogenicity to to Anti-TNF Agents in Patients With Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide written informed consent and willing to attend all study visits and complete questionnaires
- Aged 18 to 80 years at the time of consent
- Diagnosed with Crohn's disease with symptoms for at least 3 months prior to screening
- Planned to start infliximab or adalimumab therapy (including biosimilars)
- Thiopurine and corticosteroid co-therapy allowed
You will not qualify if you...
- Currently participating in another interventional study
- Unable to provide informed consent or lacking a legal guardian
- Perianal disease expected to require antibiotic therapy
- On chronic antibiotic therapy for any reason
- Ongoing internal or perianal fluid collection or abscess
- Known allergy to azithromycin or placebo components
- Prolonged QTc interval or risk factors for QT prolongation
- Chronic kidney disease stage 5 (GFR < 10)
- Crohn's disease complications requiring surgery
- Planned or ongoing methotrexate co-therapy
- Fecal microbiota transplantation within 8 weeks before randomization
- Any disorder compromising study participation as judged by investigator
- Pregnancy
- Received azithromycin within the past year
- Received any antibiotic treatment within 4 weeks before randomization
- Re-induction of the same anti-TNF medication
- On chronic therapy with colchicine, phenytoin, or digoxin that cannot be stopped
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Soroka University Medical Center
Beersheba, Israel
Actively Recruiting
2
Bnei Zion
Haifa, Israel
Actively Recruiting
3
Carmel Medical Center
Haifa, Israel
Actively Recruiting
4
Rambam Health Care Campus
Haifa, Israel
Actively Recruiting
5
Wolfson Medical Center
Holon, Israel
Actively Recruiting
6
Hadassah Medical Center
Jerusalem, Israel
Actively Recruiting
7
Shaare Zedek
Jerusalem, Israel
Actively Recruiting
8
Zvulun
Kiryat Bialik, Israel
Actively Recruiting
9
Rabin Medical Center
Petah Tikva, Israel
Actively Recruiting
Research Team
H
Haggai Bar-Yosef, MD
CONTACT
A
Anastasia Weis, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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