Microbiologically confirmed acute uncomplicated lower urinary tract infections in women. MedDRA version: 20.0 Level: HLT Classification code 10046577 Term: Urinary tract infections System Organ Class: 100000004862
Conditions
Sponsors
"Olainfarm" AS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Female outpatients aged between 18 and 55 years (inclusive). 2. Patients with all below defined clinical signs and symptoms of uUTI: • Dysuria (discomfort associated with urination). •Urinary frequency (abnormally frequent urination). •Urinary urgency (abrupt, strong, often overwhelming, need to urinate). 3. Patients with onset of symptoms of uUTI = 72 hours prior to randomization. 4. Urine dipstick test positive for either nitrites and/or leukocyte esterase. 5. Patients who signed written informed consent. 6. Patients in a good general physical and mental health as determined by Investigator. 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 745 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients who are pregnant or breast-feeding, or with positive pregnancy test at screening. 2. Patients of child-bearing potential who are not using acceptable effective contraceptive method(s). 3. Patients with vaginal discharge or irritation. 4. Patients with known or suspected hypersensitivity or intolerance to Nitrofurantoinum, Furaginum solubile, other nitrofuran derivatives, or to any excipients of investigational medicinal products. 5. Patients unable to take oral medication for any reason. 6. Patients with complicated urinary tract infection or pyelonephritis suggested by the presence of systemic and/or local signs and symptoms: fever (body temperature > 38 °C), chills, flank pain, nausea, vomiting, or costovertebral angle tenderness. 7. Patients with known (in medical history) presence of an anatomical or functional abnormality of the urinary tract including urinary calculi, stricture, primary renal disease (e.g., polycystic renal disease), neurogenic bladder. 8. Patients with the presence of urinary catheterization, currently or within the 4 weeks prior to randomization. 9. Patients with symptoms of a lower urinary tract infection (UTI) – dysuria, urinary urgency, urinary frequency – within the 4 weeks prior to the present episode. 10. Patients with three or more episodes of any UTI in the past 12 months. 11. Patients with evidence of uncontrolled diabetes mellitus. 12. Patients who received systemic antimicrobial therapy within 72 hours prior to randomization. 13. Patients who received products containing cranberry (Vaccinium macrocarpon) within 24 hours prior to randomization. 14. Patients who received Magnesium trisilicate (antacid) within 2 hours prior to randomization. 15. Patients with known immunosuppression and/or neutropenia with a neutrophil count <1000/mm3 in the past 24 months. 16. Patients with renal impairment (estimated baseline glomerular filtration rate (eGFR) < 45 mL/min/1.73 m²). 17. Patients with clinically significant pulmonary disease. 18. Patients with known anaemia, deficiency of vitamin B group or folic acid. 19. Patients with clinically significant hepatic disease. 20. Patients with polyneuropathy (including diabetic). 21. Patients with porphyria. 22. Patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency. 23. Patients requiring concomitant systemic antibacterial therapy with agents not specified in this protocol. 24. Patients requiring therapy with non-steroidal anti-inflammatory drugs (NSAIDs) on a regular basis. 25. Patients with any condition which, in the opinion of the Investigator, affects the safety of the patient, and/or the patient’s ability to participate in this study. 26. Patients previously enrolled in this clinical study and/or at the time of screening participate in other clinical study in parallel. 27. Patients taking an investigational medicinal product currently or in the last 30 days. 28. Patients who, in the opinion of the Investigator, are unsuitable for enrollment, unlikely to complete the course of study medication treatment, or unlikely to attend the end of study visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the clinical and bacteriological efficacy of Furamag 50 mg hard capsules (containing 50 mg of Furaginum solubile) in the treatment of microbiologically confirmed acute uncomplicated urinary tract infections in women taken 2 hard capsules three times a day (300 mg/day) for 5 days in comparison to the active comparator, Furantoina® 50 mg tablets (containing 50 mg of Nitrofurantoinum), taken 2 tablets three times a day (300 mg/day) for 5 days;Secondary Objective: To evaluate the safety and tolerability of Furamag 50 mg hard capsules (containing 50 mg of Furaginum solubile) in the treatment of microbiologically confirmed acute uncomplicated urinary tract infections in women taken 2 hard capsules three times a day (300 mg/day) for 5 days in comparison to the active comparator, Furantoina® 50 mg tablets (containing 50 mg of Nitrofurantoinum), taken 2 tablets three times a day (300 mg/day) for 5 days;Primary end point(s): Combined clinical and bacteriological response: Resolution of the symptoms of uUTI (clinical response) and demonstration that the true uropathogen found at randomization is reduced to less than 103 CFU/mL (bacteriological response) assessed at Visit 3 (Day 12 + 2 days) using the micro-ITT population.;Timepoint(s) of evaluation of this end point: Visit 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • For efficacy (primary population is the micro-ITT population): - Combined clinical and bacteriological response is evaluated at Visit 2 (Day 6 + 2 days) and at Visit 4 (Day 28 ± 2 days). - Clinical response (assessed by UTISA) at further ancillary time points during treatment period (Days 2–5), at Visit 2 (Day 6 + 2 days), Visit 3 (Day 12+2 days) and at Visit 4 (Day 28 ± 2 days) - Bacteriological response is evaluated at Visit 2 (Day 6 + 2 days), at Visit 3 (Day 12 + 2 days) and at Visit 4 (Day 28 ± 2 days). • For safety (assessed using safety population): AEs, SAEs, CSIs, Safety laboratory values (blood tests and urinalysis), vital signs, and physical examination findings. • For tolerability (assessed using safety population): Number of drug-related AEs/SAEs/CSIs.;Timepoint(s) of evaluation of this end point: Treatment period Day 2 - 5, Visit 2 and Visit 4 | — |
Countries
Czechia, Czech Republic, Latvia, Lithuania, Poland, Russian Federation
Contacts
Public ContactMedical and Regulatory Department
"Olainfarm" AS
Outcome results
None listed