uncomplicated lower urinary tract infections (acute or recurrent) MedDRA version: 20.0 Level: HLT Classification code 10046577 Term: Urinary tract infections System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.0 Level: PT Classification code 10046571 Term: Urinary tract infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.0 Level: LLT Classification code 10024981 Term: Lower urinary tract infection System Organ Class: 10021881 - Inf
Conditions
Interventions
Product Name: Furazidin prolonged-release tablets
Product Code: 200 mg
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Furazidine
CAS Number: 1672-88-4
Other descriptive name: FURAZ
Sponsors
Adamed Pharma S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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. For patients 7 days before Visit 1, each treatment should be evaluated individually by the Investigator to assess the risk of PK or PD carryover from previous antibiotics/ chemotherapeutic agents. 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 ovariectomy or hysterectomy), abstain from sexual intercourse 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 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? yes Number of subjects for this age range: 12 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 76 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: Exclusion criteria: 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. Travelled and stayed more than 48 hours in the country affected with SARS-CoV-2 transmission 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 duringthe 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. Known contraindications for furazidin treatment: severe pulmonary disease, diagnosed polyneuropathy, e.g., diabetic polyneuropathy, known glucose-6-phosphate dehydrogenase deficiency, anemia, known deficiency of vitamins B and folic acid, fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase deficiency. 8. 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; NOTE: Patients with mild to moderate renal impairment may be enrolled into the study, unless in Investigator’s opinion, patient will not be able to attend the study visits. 9. Any intake of systemic bacteriostatic agents within 7 days 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; NOTE in case of any bacteriostatic therapy administrated > 7 days before Visit 1, each treatment should be evaluated individually by the Investigator to assess the risk of PK or PD carryover. 10. Other acute infections (except for 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 urinary tract infection within 6 months prior to Visit 1; 15. The presence of known severe renal impairment (glomerular filtration rate < 30 ml/min). 16. Current or previous history of addiction to alcohol and/or drugs. 17. Patients who are expected to have problems with the insertion of intravenous catheters or venipuncture. 18. 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. 19. The legal inability and/or other circumstances that prevent the patient's understanding of the extent and possible influence of the study. 20. Sound suspicion that the patient fails to co
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the effectiveness of Furazidin PR in treatment of uncomplicated UTI (acute or recurrent). ;Secondary Objective: The secondary objectives of the study are: • to assess pharmacokinetics and pharmacodynamics (PK/PD) of Furazidin PR in general and special patient populations with uncomplicated UTI (acute or recurrent), • to model PK/PD relationships and assess demographic covariates and/or subpopulations in PK/PD relationships, • to evaluate safety profile of Furazidin PR, • to assess quality of life in UTI patients’ population, • observation of the treatment effectiveness at the Day 5 (First Resolution), • evaluation of patient compliance with dosing recommendation in respect to the meals, • evaluation of patients’ compliance with recommended dose regimens of Furazidin PR.;Primary end point(s): The primary efficacy criterion is defined as a composite endpoint consisting of the resolution or improvement of all clinical symptoms of urinary tract infection without need of additional antibacterial therapy and the efficacy measure according to the ACSS self-assessment scale (a score of typical symptoms of the ACSS = 5 but no item > 1 (mild) and no visible blood in urine) and the demonstration that the bacterial pathogen found at trial entry at CFU > 105 / ml is reduced to fewer than 103 CFU/mL on urine culture during Visit 5 (Test of Cure Visit, 14 (+/-2) days after treatment initiation). ;Timepoint(s) of evaluation of this end point: 14 days (+/- 2 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints assessed within the study include the following: • Assessment of population PK parameters of Furazidin PR in uncomplicated UTI (acute or recurrent) patient population such as clearance and volume of distribution including demographic covariate testing and/or subpopulation analysis, • Bacteriological assessment (PD) including pathogen identification and observed changes in bacterial count (CFU/mL) during the 7-day therapy with Furazidin PR; [Time Frame: Day 1, Day 3, Day 5, Day 7, Day 14], • Assessment of population PK/PD relationship and parameters including demographic covariate testing and/or subpopulation analysis, • Number of patients that achieved resolution or improvement of all clinical symptoms of UTI according to the ACSS self-assessment scale (a score of typical symptoms of ACSS = 5 but no item > 1 (mild)) and no visible blood in urine at Visit 3 (First Resolution), Visit 4 (End of Treatment), Visit 5 (Test of Cure), and Visit 6 (Follow-up); [Time Frame: Day 5, Day 7, Day 14, Day 28], • Number of patients that achieved reduction of pathogens count, present at the study entry (at Visit 1), to a level 1 (mild)) and no visible blood in urine); [Time Frame: Day 28], • Change in the patient self-reporting quality of life using the ACSS questionnaire at Visit 1 (Baseline), Visit 2 (PK/PD sampling), Visit 3 (First Resolution), Visit 4 (End of treatment), Visit 5 (Test of Cure), Visit 6 (Follow-up); [Time Frame: Day 1, Day 3, Day 5, Day 7, Day 14, Day 28], • Number of Treatment-Emergent AEs/ SAEs collected during the course of the study since Visit 1 until Visit 6; [Time Frame: Day 1 to Day 28], • The susceptibility of infecting strains to Furazidin PR and other antibiotics used for UTI treatment; [Time Frame: Day 1, Day 14], • Patient compliance with study treatment dosing regimen, defined as the range of 71-129% of total dose of study treatment that should be taken during the course of the study; [Time | — |
Countries
Poland
Contacts
Public ContactClinical Research Department
Adamed Pharma S.A.
Outcome results
None listed