EUCTR2020-005559-19-HU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
入排标准
- 性别
- Female
入选标准
- •Inclusion criteria
- •The patients meeting the below mentioned criteria will be included into the study:
- •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.
- •2. Age: Subject must be = 18 < 65 years of age at the time of signing the informed consent
- •3. Sex: female.
- •4. Patients with diagnosis of the acute or recurrent uncomplicated lower urinary tract infection
- •(cystitis). For the purposes of this study, urinary tract infection (cystitis) is defined by:
- •a) presence of at least two of the following clinical symptoms: dysuria, urinary
- •frequency, urinary urgency, suprapubic pain,
- •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)
- •c) presence of pyuria, as determined by a dipstick test positive for leukocyte esterase or
- •at least 10 leukocytes per cubic millimeter (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 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), or using an acceptable and effective method of contraception
- •(an acceptable method of contraception is defined as a barrier method in conjunction with a
- •spermicide) for the duration of the study and for 1 month after the last dose of Furazidin
- •PR or Nitrofurantoin PR to prevent pregnancy. In addition, oral contraceptives, approved
- •contraceptive implant, long-term injectable contraception, intrauterine device, or tubal
- •ligation are allowed. Oral contraception alone is not acceptable; additional barrier methods
- •in conjunction with spermicide must 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
- •Patients must not meet any of the following exclusion criteria:
- •1. Symptoms suggesting probability of SARS-CoV-2 infection.
- •2. Direct contact with a person suffering from COVID-19 within 14 days before Visit 1.
- •3. Traveled and stayed in the country affected with SARS-CoV-2 transmition within 14 days
- •before Visit 1.
- •4. Any symptoms of complicated urinary tract infections (cUTI), 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. 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
- •urinary tract infection.
- •6. Recurrent urinary tract infections (more than 3 episodes of infection during the last year),
- •if there was an acute episode during the last 4 weeks.
- •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 bacteriostatic agents, 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.
- •9. Other acute infections (with the exception of acute UTI) requiring antibiotic treatment at
- •10. Catheter in the bladder or any other foreign body in the urinary tracts.
- •11. Overactive bladder.
- •12. Menstrual bleeding at the day of visit.
- •13. Immunomodulatory prophylaxis due to urinary tract infection within 6 months prior to
- •14. Treatment with vitamin K antagonists (Warfarin, Acenocumarol) as long the INR test is
- •out of the normal values resulting in significant haematuria, probenecid, sulfinpirazon,
- •alkalising drugs containing magnesium trisilicate, any antibiotics / bacteriostatic drugs,
- •ristomycin, metoclopramide, nalidixic acid, atropine, levomicetin, sulphanilamide.
- •15. Pregnancy or lactation.
- •16. The presence of known severe renal impairment (creatinine clearance glomerular filtration
- •rate < 30 ml/min/1.73m2).
- •17. The presence of: 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, glucose-galactose malabsorption or sucrase-isomaltase deficiency –
- •data obtained on the basis of patient medical history.
- •18. The known history of cancer disease, that is not cured nor stable within 12 months prior
- •to Visit 1.
- •19. Active peptic ulcers.
- •20. Current or previous history of addiction to alcohol and/or drugs.
- •21. Investigator’s opinion that the patient should not participate in the study if the subject is
- •unlikely to comply with study procedures, restrictions and requirements:
- •22. The legal inability and/or other circumstances that prevent the patient's understanding of
- •the extent and possible influence of the study.
研究者
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