Phase
Condition
Urinary Tract Infections
Treatment
Fosfomycin Trometamol Salt
Nitrofurantoin
Pivmecillinam
Clinical Study ID
Ages > 18 Female
Study Summary
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
Study Description
Connect with a study center
Calatayud Center
Calatayud, Aragón 50300
SpainSite Not Available
Arrabal Health Center
Zaragoza, Aragón 50015
SpainActive - Recruiting
Las Fuentes Center
Zaragoza, Aragón 50002
SpainActive - Recruiting
Parque Goya Health Center
Zaragoza, Aragón 50018
SpainActive - Recruiting
Santa Ponça Health Center
Calvià, Balearic Islands 07180
SpainActive - Recruiting
Camp Redó Health Center
Palma De Mallorca, Balearic Islands 07010
SpainActive - Recruiting
Emili Darder Center
Palma De Mallorca, Balearic Islands 07007
SpainActive - Recruiting
Escola Graduada Health Center
Palma De Mallorca, Balearic Islands 07002
SpainActive - Recruiting
Son Pisà Center
Palma De Mallorca, Balearic Islands 07011
SpainActive - Recruiting
Son Serra-La Vileta Health Center
Palma De Mallorca, Balearic Islands 07013
SpainActive - Recruiting
Santa Maria del Camí Center
Santa Maria del Camí, Balearic Islands 07320
SpainActive - Recruiting
Banyoles Center
Banyoles, Catalonia 17820
SpainActive - Recruiting
Corbera Center
Corbera De Llobregat, Catalonia 08757
SpainActive - Recruiting
La Gavarra Health Center
Cornellà De Llobregat, Catalonia 08940
SpainActive - Recruiting
17 de Setembre Center
El Prat De Llobregat, Catalonia 08820
SpainActive - Recruiting
Can Vidalet Center
Esplugues De Llobregat, Catalonia 08950
SpainActive - Recruiting
Santa Clara Center
Girona, Catalonia 17001
SpainActive - Recruiting
Can Serra Center
Hospitalet de Llobregat, Catalonia 08906
SpainActive - Recruiting
Florida Center
Hospitalet de Llobregat, Catalonia 08905
SpainActive - Recruiting
Montblanc Center
Montblanc, Catalonia 43400
SpainActive - Recruiting
Pere Garau Center
Palma De Mallorca, Catalonia 07007
SpainActive - Recruiting
Molí Nou Center
Sant Boi De Llobregat, Catalonia 08830
SpainActive - Recruiting
Sant Feliu de Guíxols Center
Sant Feliu De Guíxols, Catalonia 17220
SpainActive - Recruiting
Sant Just Desvern Center
Sant Just Desvern, Catalonia 08960
SpainActive - Recruiting
Vila Vella Center
Sant Vicenç Dels Horts, Catalonia 08620
SpainActive - Recruiting
Jaume I Health Center
Tarragona, Catalonia 43005
SpainActive - Recruiting
El Puerto Center
Coslada, Madrid 28821
SpainActive - Recruiting
Valleaguado Health Center
Coslada, Madrid 28823
SpainActive - Recruiting
San Fernando Health Center
San Fernando De Henares, Madrid 28830
SpainActive - Recruiting
Villarejo de Salvanés Health Center
Villarejo de Salvanés, Madrid 28590
SpainActive - Recruiting
Aquitania Health Center
Madrid, 28032
SpainActive - Recruiting
Buenos Aires Center
Madrid, 28038
SpainActive - Recruiting
Los Alpes Health Center
Madrid, 28022
SpainActive - Recruiting
Mar Báltico Center
Madrid, 28033
SpainActive - Recruiting
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