DRKS00025964已完成2 期
Immunomodulatory treatment of recurrent cystitis - An open label, randomized, single-center, phase II trial - ANAKINRA
SelectImmune Pharma AB (Lund, Schweden)Org nr: 559104-68740 个研究点目标入组 30 人开始时间: 2021年7月27日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- Female
入选标准
- •Stable patients with an acute episode of recurrent uncomplicated cystitis; Signed written informed consent; Ability and willingness to comply with study procedures; Adult female patients = 18 - 65 years; Negative urine pregnancy test in women of childbearing age; Sum score of major symptoms of UUTI reported on the ACSS typical domain (Acute Cystitis Symptom Score) at visit 1 = 6; Typical symptoms must be acute and develop within = 6 days; History of recurrent cystitis (= 3 documented episodes in the history in the past year) or (= 2 documented episodes in the history in the past 6 months)); Contraception should be maintained during treatment and 30 days after the last dose. Women of childbearing age must use contraceptive methods that are considered highly effective methods of birth control. Such methods include: combined (estrogen and progestin) hormonal contraception associated with inhibition of ovulation:
- •oral, intravaginal, transdermal, or progesterone-only hormonal contraception associated with inhibition of ovulation:
- •Oral, injectable, implantable, and intrauterine device (IUD), intrauterine hormone release system (IUS), bilateral tubal occlusion, vasectomized partner, sexual abstinence. Hormonal contraceptive methods should be combined with barrier methods.
排除标准
- •Breastfeeding;
- •Signs of pyelonephritis;
- •Uncontrolled diabetes mellitus;
- •Neutropenia (<1.5x10 9/L);
- •Signs of genital infections (vaginitis/cervicitis);
- •History exclusion of patients with active severe infections, history of viral hepatitis (only anamnestic exclusion possible, as immediate inclusion in the study is urgently required for this disease pattern. Serological and other blood test results (processing time = 24 hours) cannot be waited for);
- •Patients using CYP450 drugs (e.g. warfarin, phenytoin);
- •Patients using phenytoin medications;
- •History exclusion of patients with history of tuberculosis or active tuberculosis (only anamnestic exclusion possible, as immediate inclusion in the study is urgently required for this disease pattern. Serological and other blood test results (processing time = 24 hours) cannot be waited for);
- •Extragenital conditions, nephrologic conditions, urologic conditions, urinary catheters that may lead to complicated urinary tract infection;
- •Severe uncontrolled systemic disease;
- •Systemic antibiotic therapy within 5 days prior to enrollment;
- •Impaired renal function (creatinine clearance < 60 ml /min);
- •Known allergies/contraindications to Kineret® and nitrofurantoin or their other components or to proteins derived from E. coli;
- •Malignant diseases;
- •Immunosuppression;
- •Pathological liver enzymes;
- •Polyneuropathies;
- •Glucose-6-phosphate dehydrogenase deficiency;
- •Previously participated in this study;
- •Participation in other interventional clinical trials;
- •No use of diclofenac and ibuprofen as analgesics during participation in this clinical study.
研究者
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