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 uncomplicated community-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 3127047, Aragon 3336899 50300
SpainSite Not Available
Arrabal Health Center
Zaragoza 3104324, Aragon 3336899 50015
SpainSite Not Available
Las Fuentes Center
Zaragoza 3104324, Aragon 3336899 50002
SpainSite Not Available
Parque Goya Health Center
Zaragoza 3104324, Aragon 3336899 50018
SpainSite Not Available
Calatayud Center
Calatayud, Aragón 50300
SpainSite Not Available
Arrabal Health Center
Zaragoza, Aragón 50015
SpainActive - Recruiting
Las Fuentes Center
Zaragoza, Aragón 50002
SpainSite Not Available
Parque Goya Health Center
Zaragoza, Aragón 50018
SpainActive - Recruiting
Santa Ponça Health Center
Calvià, Balearic Islands 07180
SpainSite Not Available
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
SpainSite Not Available
Santa Ponça Health Center
Calvià 2520493, Balearic Islands 2521383 07180
SpainSite Not Available
Camp Redó Health Center
Palma de Mallorca 2512989, Balearic Islands 2521383 07010
SpainSite Not Available
Emili Darder Center
Palma de Mallorca 2512989, Balearic Islands 2521383 07007
SpainSite Not Available
Son Pisà Center
Palma de Mallorca 2512989, Balearic Islands 2521383 07011
SpainSite Not Available
Son Serra-La Vileta Health Center
Palma de Mallorca 2512989, Balearic Islands 2521383 07013
SpainSite Not Available
Santa Maria del Camí Center
Santa Maria del Camí 2511138, Balearic Islands 2521383 07320
SpainSite Not Available
Banyoles Center
Banyoles, Catalonia 17820
SpainSite Not Available
Corbera Center
Corbera De Llobregat, Catalonia 08757
SpainSite Not Available
La Gavarra Health Center
Cornellà De Llobregat, Catalonia 08940
SpainSite Not Available
17 de Setembre Center
El Prat De Llobregat, Catalonia 08820
SpainSite Not Available
Can Vidalet Center
Esplugues De Llobregat, Catalonia 08950
SpainSite Not Available
Santa Clara Center
Girona, Catalonia 17001
SpainSite Not Available
Can Serra Center
Hospitalet de Llobregat, Catalonia 08906
SpainSite Not Available
Florida Center
Hospitalet de Llobregat, Catalonia 08905
SpainActive - Recruiting
Montblanc Center
Montblanc, Catalonia 43400
SpainSite Not Available
Pere Garau Center
Palma De Mallorca, Catalonia 07007
SpainActive - Recruiting
Molí Nou Center
Sant Boi De Llobregat, Catalonia 08830
SpainSite Not Available
Sant Feliu de Guíxols Center
Sant Feliu De Guíxols, Catalonia 17220
SpainSite Not Available
Sant Just Desvern Center
Sant Just Desvern, Catalonia 08960
SpainSite Not Available
Vila Vella Center
Sant Vicenç Dels Horts, Catalonia 08620
SpainSite Not Available
Jaume I Health Center
Tarragona, Catalonia 43005
SpainSite Not Available
Banyoles Center
Banyoles 3128885, Catalonia 3336901 17820
SpainSite Not Available
Corbera Center
Corbera de Llobregat 3124628, Catalonia 3336901 08757
SpainSite Not Available
La Gavarra Health Center
Cornellà de Llobregat 3124569, Catalonia 3336901 08940
SpainSite Not Available
Can Vidalet Center
Esplugues de Llobregat 3122826, Catalonia 3336901 08950
SpainSite Not Available
Santa Clara Center
Girona 3121456, Catalonia 3336901 17001
SpainSite Not Available
Can Serra Center
L'Hospitalet de Llobregat 3120619, Catalonia 3336901 08906
SpainSite Not Available
Florida Center
L'Hospitalet de Llobregat 3120619, Catalonia 3336901 08905
SpainSite Not Available
Montblanc Center
Montblanc 3116411, Catalonia 3336901 43400
SpainSite Not Available
Pere Garau Center
Palma de Mallorca, Catalonia 3336901 07007
SpainSite Not Available
Molí Nou Center
Sant Boi de Llobregat 3110834, Catalonia 3336901 08830
SpainSite Not Available
Sant Feliu de Guíxols Center
Sant Feliu de Guíxols 3110643, Catalonia 3336901 17220
SpainSite Not Available
Sant Just Desvern Center
Sant Just Desvern 3109546, Catalonia 3336901 08960
SpainSite Not Available
Vila Vella Center
Sant Vicenç dels Horts 3109442, Catalonia 3336901 08620
SpainSite Not Available
Jaume I Health Center
Tarragona 3108288, Catalonia 3336901 43005
SpainSite Not Available
17 de Setembre Center
el Prat de Llobregat 3123329, Catalonia 3336901 08820
SpainSite Not Available
El Puerto Center
Coslada, Madrid 28821
SpainSite Not Available
Valleaguado Health Center
Coslada, Madrid 28823
SpainActive - Recruiting
San Fernando Health Center
San Fernando De Henares, Madrid 28830
SpainSite Not Available
Villarejo de Salvanés Health Center
Villarejo de Salvanés, Madrid 28590
SpainSite Not Available
El Puerto Center
Coslada 3124408, Madrid 3117732 28821
SpainSite Not Available
Valleaguado Health Center
Coslada 3124408, Madrid 3117732 28823
SpainSite Not Available
Aquitania Health Center
Madrid 3117735, Madrid 3117732 28032
SpainSite Not Available
Buenos Aires Center
Madrid 3117735, Madrid 3117732 28038
SpainSite Not Available
Los Alpes Health Center
Madrid 3117735, Madrid 3117732 28022
SpainSite Not Available
Mar Báltico Center
Madrid 3117735, Madrid 3117732 28033
SpainSite Not Available
San Fernando Health Center
San Fernando de Henares 3110627, Madrid 3117732 28830
SpainSite Not Available
Villarejo de Salvanés Health Center
Villarejo de Salvanés 3104979, Madrid 3117732 28590
SpainSite Not Available
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
SpainSite Not Available

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