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]

Phase 1

• Conditions: ncomplicated Lower urinary tract infections (uLUTI); MedDRA version: 20.0Level: LLTClassification code 10046544Term: Urinary infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2021-001332-26-ES
• Lead Sponsor: IDIAP Jordi Gol

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-02
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 1000

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified