Uncomplicated Lower urinary tract infections (uLUTI) MedDRA version: 20.0 Level: LLT Classification code 10046544 Term: Urinary infection System Organ Class: 100000004862
Conditions
Interventions
Product Name: Nitrofurantoína
Pharmaceutical Form: Tablet
INN or Proposed INN: NITROFURANTOIN
CAS Number: 67-20-9
Other descriptive name: Nitrofurantoina
Concentration unit: mg milligram(s)
Concentrat
Sponsors
IDIAP Jordi Gol
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Women of 18 years of age or older, with clinical features of uncomplicated community-acquired LUTI including: (1) at least one of four key symptoms of LUTI: dysuria, urgency including nocturia, frequency, and/or suprapubic tenderness that could be attributed to an uncomplicated LUTI, and no alternative explanation (i.e. symptoms suggestive of sexually-transmitted infection or vulvovaginitis), and (2) a urine dipstick analysis positive for either nitrites or leukocyte esterase. -Agree to participate in the clinical trial. 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 800 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria
Exclusion criteria: - Male sex. - Clear signs of (i.e. high fever = 38.5°C or flank pain/tenderness) or high suspicion of pyelonephritis. - Symptoms correlating with differential diagnosis (i.e. vaginal discharge or pain). - Any condition that may lead or predispose to complicated urinary infection (i.e. indwelling urinary catheter, pregnancy, immunosuppressive therapy, abnormal urinary tracts, recurrent UTI, severe neurological disease affecting the bladder). - Pregnancy or lactation. - Symptoms consistent with UTI in the preceding 4 weeks. - Patients taking long-term antibiotic prophylaxis. - Ongoing antibiotic therapy or use of any antibiotics in the previous 7 days. - Hypersensitivity or allergy to penicillins, nitrofurantoin and/or fosfomycin. - Moderate to severe chronic renal insufficiency (stage III or higher). - Pre-existing polyneuropathy. - History of lung or liver reaction or peripheral neuropathy after previous use of nitrofurantoin. - Glucose-6-phosphate dehydrogenase deficiency. - Porphyria or systemic primary carnitine deficiency or of the type organic aciduria (i.e. methylmalonic aciduria and propionacidanaemia). - Oesophageal stricture. - Current intake of allopurinol (i.e. increases the risk of allergic skin reaction to mecillinam) or probenecid (i.e. decreases the renal excretion of mecillinam) or valproate. - Currently part of another clinical trial. - Previous enrolment in the SCOUT study. - Inability/unable to understand and/or take part in the clinical trial. - Active neoplasia - Terminal illness. - Institutionalized patients - Difficulty to perform the follow-up visits.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Day 7 (primary end point 1) Day 14 (primary end point 2);Main Objective: The main aim of the trial is double: (1) Evaluate the clinical effectiveness of the 3 short-course antibiotic regimens (3 g of fosfomycin once daily for two-days; three-day pivmecillinam 400 mg. t.i.d.; five-day nitrofurantoin 100 mg t.i.d.) and the single 3 g dose of fosfomycin in uncomplicated LUTIs in adult women at day 7; and (2) Assess the bacteriological eradication in the four medication arms, measured at day 14.;Secondary Objective: To evaluate in the four medication arms: - Time to clinical recovery. - Bacteriological efficacy at day 28. - Proportion of patients presenting a relapse of symptoms within the first four weeks after inclusion in the study and timing of relapse of symptoms and/or bacteriuria. - Proportion of patients developing complications (i.e. pyelonephritis and/or urosepsis) within the first 4 weeks. - Treatment Adherence - Proportion of patients who have taken another antibiotic during the study period. - Satisfaction with care. - Change in the quality of life. - Mapping of uropathogens causing uncomplicated LUTIs and resistance rates to the antibiotics evaluated in the project. - Predictive value of the different clinical criteria collected with microbiologically-confirmed LUTI. - Cost-effectiveness of each of the treatment arms (cost of the drug, consumption of resources and indirect costs). Evaluate the adverse reactions in each of the test strategies;Primary end point(s): Two co-primary endpoints are considered: · Co-primary endpoint no. 1, clinical effectiveness: proportion of patients who report being cured by day 7, defined as the resolution of the symptoms, answered by the patient. · Co-primary endpoint no. 2, bacteriological eradication: proportion of patients bacteriologically cured at first control urine sample, day 14. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Time to clinical recovery (D0-D7). - Bacteriological efficacy at day 28. - Proportion of patients presenting a relapse of symptoms within the first four weeks after inclusion in the study and timing of relapse of symptoms and/or bacteriuria. - Proportion of patients developing complications (i.e. pyelonephritis and/or urosepsis) within the first 4 weeks. - Treatment Adherence - Proportion of patients who have taken another antibiotic during the study period. - Satisfaction with care. - Change in the quality of life. - Cost-effectiveness of each of the treatment arms -Number of adverse reactions in each of the test strategies;Timepoint(s) of evaluation of this end point: Day 7, 14 and 28 | — |
Countries
Spain
Contacts
Public ContactUnitat Estudis Medicament
IDIAP Jordi Gol
Outcome results
None listed