EUCTR2021-001332-26-ESActive, not recruitingPhase 1
Clinical effectiveness and bacteriological eradication of 3 short-course antibiotic regimens and single-dose of fosfomicyn trometamol for lower urinary tract infections in adult women [SCOUT study]. - SCOUT
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- IDIAP Jordi Gol
- Enrollment
- 1,000
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
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
- •- 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.
Investigators
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