Personalized AZithromycin/metronidAZole Therapy in Pediatric Crohn's Disease (CD)
Megadott ok: The DSMB concluded that feasibility endpoints were reached in time for Week 4 but no participants receiving standard of care dietary treatment could be randomized based on the at-risk of the microbiome signature.
Key facts
- Where
- Pittsburgh és San Francisco, Egyesült ÁllamokSee the 2 sites
- Phase
- 2. fázis
Where in Egyesült Államok
- University of Pittsburgh Medical Center - Children's Hospital of PittsburghPittsburgh, Egyesült ÁllamokNo longer taking part
- UCSF Benioff Children's HospitalSan Francisco, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- University of North Carolina, Chapel Hill
- Trial code
- NCT04186247
- Record updated
- 2025. június 29.
- Original description
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.Read full original descriptionShow less
Personalized AZithromycin/metronidAZole, in Combination With Standard Induction Therapy, to Achieve a Fecal Microbiome Community Structure and Metagenome Changes Associated With Sustained Remission in Pediatric Crohn's Disease (CD): a Pilot Study
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.
Inclusion: 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.
Exclusion: Current or previous use of biologic therapy; Have undergone intestinal resection; Treatment with another investigational drug or other intervention within 30 days before week 0; 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; History of cockayne syndrome; Known allergy or intolerance to azithromycin or metronidazole; 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; Prior diagnosis of any hematologic condition/blood dyscrasia which may result in leukopenia (even if leukocyte count is normal at screening); 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; Presence of stricturing, penetrating (intestinal or perianal) and/or fistulizing CD; Pregnancy or lactation; Positive Clostridium Difficile toxin.