Clinical Effectiveness and Bacteriological Eradication of 4 Short-course Antibiotics for Uncomplicated UTIs in Women.

Last updated: December 5, 2023
Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Overall Status: Active - Recruiting

Phase

4

Condition

Urinary Tract Infections

Treatment

Fosfomycin Trometamol Salt

Nitrofurantoin

Pivmecillinam

Clinical Study ID

NCT04959331
IJG-SCOUT-2021
  • Ages > 18
  • Female

Study Summary

Randomized clinical trial in which women aged 18 or older and with symptoms of uncomplicated lower urinary tract infection and a positive urine dipstick analysis will be randomized to one of the following four groups: 2-day 3 g fosfomycin o.d., 3-day pivmecillinam 400 mg. t.i.d, 5-day nitrofurantoin 100 mg t.i.d. or a single dose of 3 g of fosfomycin. Sample: 1,000 patients. Two co-primary endpoints are considered: clinical effectiveness at day 7 and bacteriological eradication at day 14. Follow-up visits are scheduled at days 7 (phone call), 14 and 28 for assessing evolution. Urine samples will be collected in the three on-site visits and urine cultures performed.

Eligibility Criteria

Inclusion

Inclusion Criteria: Women of 18 years of age or older, with clinical features of uncomplicatedcommunity-acquired lower urinary tract infection including:

  • At least one of four key symptoms of lower urinary tract infection: dysuria, urgencyincluding nycturia, frequency, and suprapubic tenderness that could be attributed toan uncomplicated lower urinary tract infection, and no alternative explanation (i.e.symptoms suggestive of sexually-transmitted infection or vulvovaginitis), and
  • A urine dipstick analysis positive for either nitrites or leukocyte esterase.

Exclusion

Exclusion Criteria:

  • Male sex
  • High suspicion of pyelonephritis (i.e. fever ≥ 37.5°C or flank pain/tenderness)
  • Any condition that may lead or predispose to complicated urinary infection (i.e.indwelling urinary catheter, pregnancy, immunosuppressive therapy, abnormal urinarytracts, recurrent urinary tract infection, severe neurological disease affecting thebladder)
  • Pregnancy or planned pregnancy
  • Symptoms consistent with urinary tract infection in the preceding 4 weeks
  • Patients taking long-term antibiotic prophylaxis
  • Ongoing antibiotic therapy or use of any systemic antibiotic in the previous 7 days
  • Symptoms correlating with differential diagnosis (i.e. vaginal discharge or pain)
  • Hypersensitivity or allergy to β lactams, nitrofurantoin and/or fosfomycin
  • Moderate to severe chronic renal insufficiency
  • Pre-existing polyneuropathy
  • History of lung or liver reaction or peripheral neuropathy after previous use ofnitrofurantoin
  • Glucose-6-phosphate dehydrogenase deficiency
  • Porphyria or systemic primary carnitine deficiency or of the type organic aciduria (i.e. methylmalonic aciduria and propionicacidaemia)
  • Esophageal stricture
  • Current intake of allopurinol or probenecid or valproate
  • Currently part of another randomized clinical trial
  • Previous enrolment in the proposed study
  • Patients living in long-term institutions; and/or
  • Difficulty in conducting scheduled follow-up visits

Study Design

Total Participants: 1000
Treatment Group(s): 3
Primary Treatment: Fosfomycin Trometamol Salt
Phase: 4
Study Start date:
November 02, 2021
Estimated Completion Date:
December 31, 2024

Study Description

Uncomplicated lower urinary tract infections (LUTI) represent a common problem in primary care. Resistance of uropathogens to common antibiotics has significantly increased in the last years. Current local guidelines recommend the use of a single 3 g dose of fosfomycin for these infections, but most general practitioners prefer short-course therapies to single-dose therapy. No study has compared head-to-head short course antimicrobial agents for uncomplicated LUTIs. Therefore, the aim of this randomized clinical trial is to compare three different short-course antibiotic therapies with single-dose fosfomycin for uncomplicated LUTIs in adult women. This will be a pragmatic, multicenter, parallel group, open randomized trial. Women aged 18 or older and with symptoms of uncomplicated LUTI and a positive urine dipstick analysis will be randomized to one of the following four groups: 2-day 3 g fosfomycin o.d., 3-day pivmecillinam 400 mg. t.i.d, 5-day nitrofurantoin 100 mg t.i.d. or a single dose of 3 g of fosfomycin. Sample: 1,000 patients. Two co-primary endpoints are considered: clinical effectiveness, defined as resolution of symptoms, answered by the patients at day 7, and bacteriological eradication (proportion of patients bacteriologically cured) at day 14. Patients will be given a symptom diary for seven days. Follow-up visits are scheduled at days 7 (phone call), 14 and 28 for assessing evolution. Urine samples will be collected in the three on-site visits and urine cultures performed. If positive, antibiograms for the 3 antibiotics studied will be performed.

Connect with a study center

  • Calatayud Center

    Calatayud, Aragón 50300
    Spain

    Site Not Available

  • Arrabal Health Center

    Zaragoza, Aragón 50015
    Spain

    Active - Recruiting

  • Las Fuentes Center

    Zaragoza, Aragón 50002
    Spain

    Active - Recruiting

  • Parque Goya Health Center

    Zaragoza, Aragón 50018
    Spain

    Active - Recruiting

  • Santa Ponça Health Center

    Calvià, Balearic Islands 07180
    Spain

    Active - Recruiting

  • Camp Redó Health Center

    Palma De Mallorca, Balearic Islands 07010
    Spain

    Active - Recruiting

  • Emili Darder Center

    Palma De Mallorca, Balearic Islands 07007
    Spain

    Active - Recruiting

  • Escola Graduada Health Center

    Palma De Mallorca, Balearic Islands 07002
    Spain

    Active - Recruiting

  • Son Pisà Center

    Palma De Mallorca, Balearic Islands 07011
    Spain

    Active - Recruiting

  • Son Serra-La Vileta Health Center

    Palma De Mallorca, Balearic Islands 07013
    Spain

    Active - Recruiting

  • Santa Maria del Camí Center

    Santa Maria del Camí, Balearic Islands 07320
    Spain

    Active - Recruiting

  • Banyoles Center

    Banyoles, Catalonia 17820
    Spain

    Active - Recruiting

  • Corbera Center

    Corbera De Llobregat, Catalonia 08757
    Spain

    Active - Recruiting

  • La Gavarra Health Center

    Cornellà De Llobregat, Catalonia 08940
    Spain

    Active - Recruiting

  • 17 de Setembre Center

    El Prat De Llobregat, Catalonia 08820
    Spain

    Active - Recruiting

  • Can Vidalet Center

    Esplugues De Llobregat, Catalonia 08950
    Spain

    Active - Recruiting

  • Santa Clara Center

    Girona, Catalonia 17001
    Spain

    Active - Recruiting

  • Can Serra Center

    Hospitalet de Llobregat, Catalonia 08906
    Spain

    Active - Recruiting

  • Florida Center

    Hospitalet de Llobregat, Catalonia 08905
    Spain

    Active - Recruiting

  • Montblanc Center

    Montblanc, Catalonia 43400
    Spain

    Active - Recruiting

  • Pere Garau Center

    Palma De Mallorca, Catalonia 07007
    Spain

    Active - Recruiting

  • Molí Nou Center

    Sant Boi De Llobregat, Catalonia 08830
    Spain

    Active - Recruiting

  • Sant Feliu de Guíxols Center

    Sant Feliu De Guíxols, Catalonia 17220
    Spain

    Active - Recruiting

  • Sant Just Desvern Center

    Sant Just Desvern, Catalonia 08960
    Spain

    Active - Recruiting

  • Vila Vella Center

    Sant Vicenç Dels Horts, Catalonia 08620
    Spain

    Active - Recruiting

  • Jaume I Health Center

    Tarragona, Catalonia 43005
    Spain

    Active - Recruiting

  • El Puerto Center

    Coslada, Madrid 28821
    Spain

    Active - Recruiting

  • Valleaguado Health Center

    Coslada, Madrid 28823
    Spain

    Active - Recruiting

  • San Fernando Health Center

    San Fernando De Henares, Madrid 28830
    Spain

    Active - Recruiting

  • Villarejo de Salvanés Health Center

    Villarejo de Salvanés, Madrid 28590
    Spain

    Active - Recruiting

  • Aquitania Health Center

    Madrid, 28032
    Spain

    Active - Recruiting

  • Buenos Aires Center

    Madrid, 28038
    Spain

    Active - Recruiting

  • Los Alpes Health Center

    Madrid, 28022
    Spain

    Active - Recruiting

  • Mar Báltico Center

    Madrid, 28033
    Spain

    Active - Recruiting

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