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
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. 2. Age: Subject must be = 18 =65 years) no F.1.3.1 Number of subjects for this age range
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. 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 Visit 1. 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 Visit 1. 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. 23. Sound
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to demonstrate at least the same efficacy (a non-inferiority design) of Furazidin PR versus Nitrofurantoin PR in the treatment of the uncomplicated lower urinary tract infections (cystitis) in women (acute or recurrent).;Secondary Objective: The secondary objectives of the study are: • assessment of microbial response; • assessment of clinical response; • patient assessment of efficacy and quality of life; • evaluation of patient compliance with dosing regimen; • evaluation of safety profile; • observation of the treatment efficacy during Visit 2 at Day 5 (First Resolution) to find out whether the study results will be supportive enough to make the treatment posology shorter); • evaluation of patient compliance with dosing recommendation in respect to the meals.;Primary end point(s): The primary efficacy criteria 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 is reduced to fewer than 103 CFU/mL on urine culture during Visit 4 (Test of Cure Visit, 14 (+/- 2) days after completion of treatment).;Timepoint(s) of evaluation of this end point: 14 days (+/- 2 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy parameters include the following: • 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 2, Visit 3 (End of Treatment), Visit (Test of Cure), and Visit 5 (Follow up) in Furazidin PR arm in relation to Nitrofurantoin PR arm; [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 or = 105/ml and nitrofurantoine susceptibility will be assessed for microbiological secondary endpoint. • Number of patients with a need of any additional antimicrobial medication intake for UTI between Visit 1 and Visit 4 and between Visit 1 and Visit 5 in Furazidin PR arm in relation to Nitrofurantoin PR arm; [Time Frame: Day 5, Day 7, Day 14, Day 28]; • Maintenance of clinical response until Day 28 (Visit 5 - Follow up) in Furazidin PR arm in relation to Nitrofurantoin PR arm, based on the ACSS self-assessment scale (a score of typical symptoms of ACSS = 5 but no item > 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, Visit 2 (First Resolution), Visit 3 (End of treatment), Visit 4 (Test of Cure), Visit 5 ( Followup); in Furazidin PR arm in relation to Nitrofurantoin PR arm; [Time Frame: Day 1, 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 5 in Furazidin PR arm in relation to Nitrofurantoin PR; [Time Frame: Day 1 to Day 28]; • The susceptibility of infecting strains to Furazidin PR and Nitrofurantoin PR; [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 s | — |
Countries
Germany, Hungary, Poland, Russian Federation
Contacts
Public ContactPiotr Witkowski
ADAMED Pharma S.A.
Outcome results
None listed