Clinical Drug Experience Knowledgebase

Criteria

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