Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Prevention
Participants needed
180 (estimated)
Sponsor
Rambam Health Care Campus · Other
Who this trial is looking for
This trial is looking for adults with Crohn's disease who are starting anti-TNF therapy. Participants will take a short course of azithromycin before beginning their treatment.
Are You a Good Fit for This Trial?
Must be takingThiopurineCorticosteroid
Rules you outSevere complications of Crohn's diseaseProlonged QTc interval
You may be able to join if
I am between 18 and 80 years old.
I have been diagnosed with Crohn's disease for at least 3 months.
I plan to start treatment with infliximab or adalimumab.
I can read and write to complete questionnaires.
I can provide written consent and attend all study visits.
You may not be able to join if
I am involved in another clinical trial.
I cannot provide informed consent.
I have ongoing infection or abscess related to Crohn's disease.
I have a history of allergy to azithromycin.
I am pregnant.
I have chronic kidney disease stage 5.
I have taken azithromycin in the past year.
I have received antibiotics in the last 4 weeks.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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
Trial Locations
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Status
Eligibility Criteria
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 a…
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
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