Using azithromycin to reduce immune reactions in Crohn's disease patients starting anti-TNF therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a randomized placebo-controlled study aimed at Crohn's disease patients who are about to begin anti-TNF therapy. It investigates whether a short course of azithromycin can lower the development of anti-drug antibodies (ADA), which can reduce the effectiveness of these treatments. The study will compare the outcomes of patients receiving azithromycin with those receiving a placebo, while also analyzing historical data for additional insights. The primary outcome measure will be the rate of ADA development after one year of therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Ability to provide written informed consent prior to any study procedures and willing and able to attend all study visits, comply with the study procedures, read and write in order to complete questionnaires, and be able to complete the study period.
* Aged 18 to 80 years of age, inclusive, at the time of signing the informed consent.
* Diagnosis of CD with an onset of symptoms for a minimum of 3 months prior to Screening as determined by the investigator based on clinical history, exclusion of infectious causes, and characteristic endoscopic and histologic findings.
* Prior decision of starting infliximab or adalimumab therapy (including biosimilar drugs).
* Thiopurine and corticosteroid co-therapy will be permitted.

Exclusion Criteria:

* Inclusion in another interventional study
* Patients who cannot provide informed consent and do not have a legal guardian
* Patients with perianal involvement who are expected to require antibiotic therapy for their disease
* Patients on chronic antibiotic therapy due to any cause
* Patients with ongoing fluid collection/abscess either internal or perianal
* Known history of allergy to the study intervention formulation or any of its excipients or components of the delivery device
* Prolonged QTc interval or conditions leading to additional risk for QT prolongation
* Chronic kidney disease stage 5 (GFR \< 10)
* Crohn's Disease complication requiring surgical treatment
* Planned/ongoing methotrexate co-therapy
* Fecal microbiota transplantation within 8 weeks prior to randomization
* Participant has any disorder that, in the opinion of the investigator, may compromise the ability to participate in the study
* Pregnancy
* Patients who received azithromycin therapy in the previous year (we will not exclude prior use of other antibiotic therapy)
* Patients who received any antibiotic treatment within 4 weeks prior to randomization
* Re-induction of the same anti-TNF medication
* Patients who are on chronic therapy which cannot be withheld in one of these medications: colchicine, phenytoin, and digoxin

Where it's running

• Rambam Health Care Campus
  Haifa, Haifa District, Israel Recruiting
• Soroka University Medical Center
  Beersheba, Israel Recruiting
• Bnei Zion
  Haifa, Israel Recruiting
• Carmel Medical Center
  Haifa, Israel Recruiting
• Wolfson Medical Center
  Holon, Israel Recruiting
• Hadassah Medical Center
  Jerusalem, Israel Recruiting

Study contacts

• Study coordinator: Haggai Bar-Yosef, MD
• Email: h_bar-yoseph@rmc.gov.il
• Phone: 050-2064878

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.