Efficacy and Safety of Nitrofurantoin in the Treatment of Uncomplicated Urinary Tract Infections in Adults

Inclusion criteria

• non-pregnant women and men aged above 18 years old
• presence of ≥ 2 signs or symptoms suggestive of a UTI (dysuria, urinary frequency, urgency, suprapubic pain) with onset 10 days before enrollment
• asymptomatic patients with available positive urine culture
• pyuria defined as positive leucocyte esterase (LE) test with any color change after two minutes
• collection of clean-voided midstream urine sample for culture and susceptibility testing to confirm bacteriuria
• normal renal function (defined as blood creatinine < 1.4 mg/100 ml)
• able to take oral medication on an outpatient basis
• written informed consent before enrollment

Exclusion criteria

• suspicion of complicated UTI (presence of fever above 38°C, flank pain, known urologic structural abnormality) or prostatitis
• negative urine dipslide results (uropathogen < 100000 CFU (colony-forming units)/mL) or presence of nitrofurantoin resistant isolate uropathogens or mixed cultures of more than two isolates
• symptoms of UTI within the past 4 weeks
• evidence of predisposing factor to UTI (e.g. calculi, stricture, primary renal disease like polycystic renal diseases and neurogenic bladder)
• medical history of anaemia, complicated diabetes mellitus, peripheral neuropathy, vitamin B deficiency, renal insufficiency, other significant renal, hepatic or lung diseases
• medical history of glucose-6-phosphate dehydrogenase deficiency (G6PD)
• electrolytes disorders
• pregnant, breast-feeding women or not using medically accepted, effective method of birth control
• history of nitrofurantoin hypersensitivity
• use of systemic bacteriological agent within 48 hours before enrollment