EUCTR2020-005559-19-DE进行中（未招募）1 期
FRUTI - a phase III, randomized, multicenter, double-blind, active control study to evaluate the efficacy and safety of Furazidin prolonged-release tablets, 200 mg compared with Nitrofurantoin prolonged-release capsules, 100 mg, in the treatment of patients with uncomplicated lower urinary tract infections (acute or recurrent) - FRUTI
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 636
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
- Female
入选标准
- •1. Informed Consent: Willingness to comply with all the study activities and procedures and provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses. For pediatric population – parents’ or legal guardian’s informed consent required.
- •2. Age: Subject must be = 12 years of age at the time of signing the informed consent form.
- •Germany only: Subject must be = 18 years of age at the time of signing the informed consent form.
- •3. Sex: female.
- •4. Patients with diagnosis of acute or recurrent uncomplicated cystitis. For the purposes of this study, acute uncomplicated urinary tract infection is defined by:
- •a. presence of at least two of the following clinical symptoms: dysuria, urinary frequency, urinary urgency, suprapubic pain, and
- •b. at least a score of 6 of typical symptoms obtained by the Acute Cystitis Symptom Score (ACSS) questionnaire applied as additional tool for the clinical inclusion
- •criteria defined by the draft guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (EMA/844951/2018 Rev. 3), and
- •c. presence of pyuria, as determined by a dipstick test positive for leukocyte esterase or at least 10 leukocytes per cubic millimeter [1 µl] (WBC = 10/mm3) as required by the draft EMA Guideline (EMA/844951/2018 Rev. 3).
- •5. Onset of symptoms of urinary tract infection at least 12 hours but not more than 72h prior to Visit 1 (Screening).
- •6. No prior treatment with systemic antibiotics and/ or chemotherapeutic agents for any reason within 7 days prior to Visit 1.
- •7. Negative urine pregnancy test for female subjects of childbearing potential.
- •8. Female patients must be post-menopausal (i.e.: no menstrual bleeding for at least 12 consecutive months), surgically sterile (i.e. after surgery as bilateral tubal ligation, bilateral ovarectomy or hysterectomy), abstain from sexual intercourse or using an acceptable and highly-effective method of contraception (defined as: combined oral, transdermal or intravaginal (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner, sexual abstinence) for the duration of the study and for 1 month after the last dose of Furazidin PR or Nitrofurantoin PR to prevent pregnancy. Additional barrier methods in conjunction with spermicide are recommended to be used.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 636
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Symptoms suggesting probability of SARS-CoV-2 infection or known positive COVID-19 rapid antigen test within last 7 days.
- •2. Direct contact with a person suffering from COVID-19 within 14 days before Visit 1.
- •3. Travelled and stayed more than 48 hours in the country affected with SARS-CoV-2 transmission within 14 days before Visit 1, with an exemption of fully anti-COVID-19
- •vaccinated patients.
- •4. Any symptoms of complicated UTI, pyelonephritis (i.e., fever T = 38.0°C, flank pain (costovertebral angle pain), chills and/or inflammation of the vulva and vagina and/or abnormal discharge from the vagina or urethra at Visit 1.
- •5. Known clinically significant anatomic and functional disorders of the urinary tracts (including, but not limited to congenital malformations, conditions after surgery within the urogenital tracts during the last 30 days, clinically significant residual urine (more than 100 ml of urine being retained in urinary bladder based on PVR USG examination*), neurogenic bladder, urolithiasis, urogenital system malignancies) allowing to recognize complicated UTI.
- •*if required, at discretion of Investigator.
- •6. Previous UTI episode treated (resolved or unresolved) within 4 weeks before Visit 1.
- •7. As judged by the investigator, any evidence of disease/condition which in the investigator’s opinion makes it undesirable for the subject to participate in the trial.
- •8. Any intake of systemic bacteriostatic agents and/ or antibiotics within 7d prior to Visit 1 and OTC drugs, including ibuprofen and other NSAIDs, and/or dietary supplements, food preparations used in the urinary tract infections, within 7 days prior to Visit 1, with an exemption for acetylosalicylic acid at a stable dose of 75 mg or 150 mg per day, taken over 30 days before Visit 1 to reduce blood clotting.
- •9. Hypersensitivity to furazidin, nitrofurantoin, nitrofuran derivatives or other drug components.
- •10. Other acute infections (except acute UTI) requiring antibiotic treatment at Visit 1.
- •11. Catheter in the bladder or any other foreign body in the urinary tracts.
- •12. Overactive bladder.
- •13. Menstrual bleeding at the day of visit.
- •14. Immunomodulatory prophylaxis due to UTI within 6 months prior to Visit 1.
- •15. Treatment with vit. K antagonists (...) as long the INR test is out of the normal values resulting in significant haematuria (decision about randomization based on the last known INR results), probenecid, sulfinpirazon, alkalising drugs containing magnesium trisilicate, ristomycin, metoclopramide, nalidixic acid, atropine, levomicetin, sulphanilamide within 7 days before Visit 1.
- •16. Presence of known severe renal impairment.
- •17. Known presence of:
- •a. severe abdominal pain with special attention to pancreatitis (strong abdominal pain in the area of epi- or mesogastrium, girdle or radiating to back area, nausea and
- •vomiting, diarrhorea) – data obtained on the basis of patient medical interview and physical examination.
- •b. electrolytes disturbancies (based on symptoms assessment (...))- data obtained on the basis of patient medical interview and physical exam.
- •c. polycystic kidney disease, severe pulmonary disease, diagnosed polyneuropathy, e.g. diabetic polyneuropathy, known glucose-6-phosphate dehydrogenase deficiency,
- •anemia, known deficiency of vitamins B and folic acid, neutropenia, severe thrombocytopenia, liver failure, porphyria, immunosuppressive or immunomodulatory treatment, HIV/AIDS infection, chemotherapy, steroid therapy, fructose intolerance,
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