EUCTR2019-004219-29-NL进行中（未招募）1 期
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” - PAZAZ
Amsterdam UMC0 个研究点目标入组 20 人开始时间: 2020年2月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Provision of signed and dated informed consent form (and assent form, as applicable)
- •2. Stated willingness to comply with all study procedures and availability for the duration of the study
- •3. Male or female, aged 3 to 17 years
- •4. Diagnosed with CD according to standard clinical and histological criteria, within 36 months of week 0
- •5. Exhibiting mild to moderate symptoms of active disease, as determined by a PCDAI score >10 (or >7.5 excluding the height item) and =37.5
- •6. Evidence of active inflammation based on either: fecal calprotectin level >=250 microgram/g (local laboratory or pre-arranged sponsor testing) within 30 days prior to week 0 visit; or according to accepted endoscopic and histologic evidence obtained during an endoscopy procedure completed within 30 days prior to Week 0 Visit.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 20
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.Current or previous use of anti-TNF or other biologic therapy
- •2.Presence of stricturing, penetrating (intestinal or perianal) and/or fistulizing CD.
- •3.Pregnancy or lactation
- •4.Have undergone intestinal resection
- •5.Laboratory diagnosis of Clostridium Difficile Infection (CDI), if performed for clinical indication
- •6.Treatment with another investigational drug or other intervention within 30 days before week 0
- •7.Risk factors for arrhythmia including history of prolonged QTc, hypokalemia or hypomagnesemia, resting bradycardia, or concurrent treatment with other drugs with potential for QT prolongation.
- •8.History of Cockayne syndrome
- •9.Prior diagnosis of any hematologic condition/blood dyscrasia which may result in leukopenia (even if leukocyte count is normal at screening)
- •10.Known allergy or intolerance to azithromycin or metronidazole
- •11.Subjects who received IV anti-infective within 35 days prior to week 0 visit or oral anti-infectives within 14 days prior to the week 0 visit.
- •12.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.
- •13.Subject on cyclosporine, tacrolimus or mycophenolate mofetil. Stable doses (no change within 14 days prior to week 0) of Azathioprine, 6-mercaptopurine or MTX are not a reason for exclusion.
- •14.Subject who received fecal microbial transplantation within 35 days prior to week 0 visit.
- •15.Screening laboratory and other analyses show any of the following abnormal results:
- •o AST, ALT > 2 X upper limit of the reference range (as determined locally at each site)
- •o Urea, Creatinine > 1.5X upper limit of the reference range (as determined locally at each site)
- •o White blood cell (WBC) count < 3.0 X 109/L
- •o Total bilirubin >= 20 micromol/liter (1.17mg/dl); except for subjects with isolated elevation of indirect bilirubin relating to Gilbert syndrome
- •o Hemoglobin < 80 gram/liter
- •o Platelets < 100,000/µL
研究者
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