RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Azithromycin Pill for Crohn's Disease Relapse

Q: Is NCT05599347 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

Q: What phase is NCT05599347?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Q: Can PlainTrials tell me if I qualify for NCT05599347?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

This is a randomly assigned compared with a dummy treatment 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

Official registry: https://clinicaltrials.gov/study/NCT05599347 · Rambam Health Care Campus · enrollment listed as 180

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Azithromycin Pill, or Placebo. The registry lists allocation as randomized. This is a randomly assigned compared with a dummy treatment 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

They plan to enroll about 180 people at 9 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Pre-treatment With Azithromycin to Reduce Immunogenicity to Anti-Tumor Necrosis Factor-α Agents in Patients With Crohn's Disease

Interventions: Azithromycin Pill, Placebo

Primary outcome (registry wording): Anti-drug antibody development

Who it is for (from inclusion criteria)

Ages 18 Years to any
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

Who the registry excludes

Inclusion in another treatment study
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)

Public study contact (from the registry)

Haggai Bar-Yosef, MD

050-2064878

h_bar-yoseph@rmc.gov.il

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

9 listed

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)
Shaare Zedek — Jerusalem, Israel (recruiting)
Zvulun — Kiryat Bialik, Israel (recruiting)
Rabin Medical Center — Petah Tikva, Israel (recruiting)

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FAQ about this NCT record

Is NCT05599347 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05599347?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05599347?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary