Personalized AZithromycin/metronidAZole Therapy in Pediatric Crohn's Disease (CD)

Stopped early · Phase 2

Conditions studied: Crohn Disease, Pediatric Crohns Disease

In brief

This is a multi-center, randomized, controlled open-label add-on design trial pilot study to evaluate the efficacy of personalized adjunctive antibiotic (azithromycin + metronidazole) therapy in pediatric subjects with mild to moderate Crohn's disease (CD) who have a microbiome profile associated with increased risk of early relapse. This an add-on design trial for subjects already receiving standard of care therapy to induce remission; there will be no placebos.

Key facts

Study ID: NCT04186247
Run by: University of North Carolina, Chapel Hill
People needed: 13
Starts: 2021-08-13
Expected to finish: 2023-12-31
Last updated by the study team: 2025-06-29

Who can join

Age: 3 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Provision of signed and dated informed consent form (and assent form, as applicable);
Stated willingness to comply with all study procedures and availability for the duration of the study;
Male or female, aged 3 to 17 years;
Diagnosed with CD according to standard clinical and histological criteria, within 36 months of week 0;
Exhibiting mild to moderate symptoms of active disease, as determined by a Pediatric Crohn's Disease Activity Index (PCDAI) score >10 (or > 7.5 excluding the height item) and ≤37.5;
Fecal calprotectin level >=250 µg/g within 30 days prior to week 0 visit based on local measurement, if available, or to be arranged with lead site if an endoscopy is not performed within 30 days prior to week 0 visit.

You may not qualify if…

Current or previous use of biologic therapy;
Presence of stricturing, penetrating (intestinal or perianal) and/or fistulizing CD;
Pregnancy or lactation;
Have undergone intestinal resection;
Positive Clostridium Difficile toxin;
Treatment with another investigational drug or other intervention within 30 days before week 0;
Risk factors for arrhythmia including history of prolonged corrected QT interval (QTc), hypokalemia or hypomagnesemia, resting bradycardia, or concurrent treatment with other drugs with potential for QT prolongation;
History of cockayne syndrome;
Prior diagnosis of any hematologic condition/blood dyscrasia which may result in leukopenia (even if leukocyte count is normal at screening);
Known allergy or intolerance to azithromycin or metronidazole;
Subjects who received intravenous anti-infective within 35 days prior to week 0 visit or anti-infectives within 14 days prior to the week 0 visit;
Subject on oral aminosalicylates who has not been on stable doses for greater than, or discontinued within, at least 14 days prior to week 0;
Subject on cyclosporine, tacrolimus or mycophenolate mofetil. Stable doses (no change within 14 days prior to week 0) of azathioprine, 6-mercaptopurine or methotrexate (MTX) are not a reason for exclusion;
Subject who received fecal microbial transplantation within 35 days prior to week 0 visit;
Screening laboratory and other analyses show any of the following abnormal results:
aspartate transaminase (AST), alanine transaminase (ALT) > 2 X upper limit of the reference range,
White blood cell (WBC) count < 3.0 X 109/L,
Total bilirubin >= 20 micromol/liter (1.17 mg/dL); except for subjects with isolated elevation of indirect bilirubin relating to Gilbert syndrome,
Estimated glomerular filtration rate (GFR) by simplified 4-variable Modification of Diet in Renal Disease (MDRD) formula of < 30 mL/min/1.73 m²,
Hemoglobin < 80 gram/liter,
Platelets < 100,000/µL.

Where it is running

UCSF Benioff Children's Hospital — San Francisco, California, United States
University of Pittsburgh Medical Center, Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
IWK Health Centre — Halifax, Canada
Wolfson Medical Centre — Tel Aviv, Israel
Amsterdam UMC — Amsterdam, Netherlands

Full record on ClinicalTrials.gov

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